Trial Outcomes & Findings for Study Evaluating Safety, Tolerability and Clinical Activity of GSK2857916 in Combination With Pembrolizumab in Subjects With Relapsed/Refractory Multiple Myeloma (RRMM) (NCT NCT03848845)

NCT ID: NCT03848845

Last Updated: 2024-04-09

Results Overview

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 41 participants
• Primary outcome timeframe: Up to approximately 31 months
• Results posted on: 2024-04-09

Participant Flow

The study consisted of two phases - Main Study Phase and Post Analysis Continued Treatment (PACT) Phase. In PACT phase those participants still benefiting from drug continued to receive study drug until discontinued or withdrawn from study.

Total of 41 participants were enrolled in this study.

Participant milestones

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion Participants were administered belantamab mafodotin with recommended phase 2 dose (RP2D) of 2.5 mg/kg in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.	PACT Phase- Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Participants who completed approximately 178 weeks of treatment of 2.5 mg/kg belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion had the opportunity to continue receiving belantamab mafodotin in the PACT phase up to approximately 221 weeks.
Main Study Phase (Day 1 to Week 178) STARTED	6	7	28	0
Main Study Phase (Day 1 to Week 178) COMPLETED	3	4	19	0
Main Study Phase (Day 1 to Week 178) NOT COMPLETED	3	3	9	0
PACT Phase (Week 178 to Week 221) STARTED	0	0	0	2
PACT Phase (Week 178 to Week 221) COMPLETED	0	0	0	1
PACT Phase (Week 178 to Week 221) NOT COMPLETED	0	0	0	1

Reasons for withdrawal

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion Participants were administered belantamab mafodotin with recommended phase 2 dose (RP2D) of 2.5 mg/kg in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.	PACT Phase- Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Participants who completed approximately 178 weeks of treatment of 2.5 mg/kg belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion had the opportunity to continue receiving belantamab mafodotin in the PACT phase up to approximately 221 weeks.
Main Study Phase (Day 1 to Week 178) Lost to Follow-up	0	1	0	0
Main Study Phase (Day 1 to Week 178) Physician Decision	0	0	1	0
Main Study Phase (Day 1 to Week 178) Withdrawal by Subject	3	2	8	0
PACT Phase (Week 178 to Week 221) Withdrawal by Subject	0	0	0	1

Baseline Characteristics

Study Evaluating Safety, Tolerability and Clinical Activity of GSK2857916 in Combination With Pembrolizumab in Subjects With Relapsed/Refractory Multiple Myeloma (RRMM)

Baseline characteristics by cohort

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=6 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation n=7 Participants Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion n=28 Participants Participants were administered belantamab mafodotin with recommended phase 2 dose (RP2D) of 2.5 mg/kg in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.	Total n=41 Participants Total of all reporting groups
Age, Continuous	66.8 YEARS STANDARD_DEVIATION 12.09 • n=5 Participants	67.7 YEARS STANDARD_DEVIATION 9.21 • n=7 Participants	61.5 YEARS STANDARD_DEVIATION 9.41 • n=5 Participants	63.3 YEARS STANDARD_DEVIATION 9.92 • n=4 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants	19 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	3 Participants n=7 Participants	18 Participants n=5 Participants	22 Participants n=4 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Black OR African American	1 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	7 Participants n=4 Participants
Race/Ethnicity, Customized White	5 Participants n=5 Participants	5 Participants n=7 Participants	23 Participants n=5 Participants	33 Participants n=4 Participants

PRIMARY outcome

Timeframe: Up to approximately 31 months

Population: All Treated Population included all participants who received at least one dose of study treatment.

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=6 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation n=7 Participants Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 1 - Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	4 Participants	5 Participants
Part 1 - Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	6 Participants	7 Participants

PRIMARY outcome

Timeframe: Up to 21 days

Population: All Treated Population

DLT is an AE that is considered by the investigator to be clinically relevant and attributed to the study therapy during the 21 day DLT period and meets at least one of the DLT criteria: any Grade 4 and 3 non-hematologic toxicity, any Grade 3 or greater non-hematologic laboratory value, hematologic toxicity lasting >=7 days, except Grade 4 thrombocytopenia of any duration or Grade 3 thrombocytopenia associated with clinically significant bleeding. Grade 3 or greater febrile neutropenia lasting >48 hours (h) despite adequate treatment, Nephrotoxicity requiring dialysis, Liver toxicity, prolonged delay (>14 days) in initiating Cycle 2 due to any treatment (pembrolizumab or GSK2857916) related toxicity, any treatment-related toxicity that causes discontinuation of treatment during Cycle 1, any other toxicity considered to be dose-limiting that occurs beyond 21 days and any other event which in the judgment of the investigator and GlaxoSmithKline Medical Monitor is considered to be a DLT.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=6 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation n=7 Participants Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 1 - Number of Participants With Dose Limiting Toxicities (DLTs)	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) and up to approximately 31 months

Population: All Treated Population

Blood samples were collected for the analysis of following hematology parameters: hemoglobin, White blood cells (WBC) count, lymphocytes, neutrophils and platelet count. The laboratory parameters were graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Any worst-case post baseline increase in grade along with any increase to a maximum grade of 3 and a maximum grade of 4 are presented.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=6 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation n=7 Participants Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters Hemoglobin Decreased (Anemia), Any Grade Increase	4 Participants	2 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters Hemoglobin Decreased (Anemia), Increase to Grade 3	3 Participants	1 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters Hemoglobin Decreased (Anemia), Increase to Grade 4	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters Hemoglobin Increased, Any Grade Increase	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters Hemoglobin Increased, Increase to Grade 3	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters Hemoglobin Increased, Increase to Grade 4	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters WBC Increased (Leukocytosis), Any Grade Increase	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters WBC Increased (Leukocytosis), Increase to Grade 3	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters WBC Increased (Leukocytosis), Increase to Grade 4	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters WBC Decreased, Any Grade Increase	3 Participants	3 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters WBC Decreased, Increase to Grade 3	1 Participants	1 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters WBC Decreased, Increase to Grade 4	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters Lymphocyte Decreased, Any Grade Increase	4 Participants	1 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters Lymphocyte Decreased, Increase to Grade 3	1 Participants	1 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters Lymphocyte Decreased, Increase to Grade 4	1 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters Lymphocyte Increased, Any Grade Increase	0 Participants	1 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters Lymphocyte Increased, Increase to Grade 3	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters Lymphocyte Increased, Increase to Grade 4	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters Neutrophil Decreased, Any Grade Increase	5 Participants	2 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters Neutrophil Decreased, Increase to Grade 3	2 Participants	1 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters Neutrophil Decreased, Increase to Grade 4	0 Participants	1 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters Platelet Decreased, Any Grade Increase	5 Participants	5 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters Platelet Decreased, Increase to Grade 3	3 Participants	3 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters Platelet Decreased, Increase to Grade 4	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) and up to approximately 31 months

Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.

Blood samples were collected for the analysis of following hematology parameters: basophils, eosinophils, mean corpuscular hemoglobin concentration (MCHC), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), erythrocytes, hematocrit, monocytes, neutrophils and reticulocyte. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=6 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation n=7 Participants Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters Basophils, Decrease to Low	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters Basophils, Change to Normal or No Change	6 Participants	6 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters Basophils, Increase to High	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters Eosinophils, Decrease to Low	2 Participants	1 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters Eosinophils, Change to Normal or No Change	4 Participants	6 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters Eosinophils, Increase to High	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters MCHC, Decrease to Low	0 Participants	1 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters MCHC, Change to Normal or No Change	6 Participants	4 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters MCHC, Increase to High	0 Participants	2 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters MCH, Decrease to Low	2 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters MCH, Change to Normal or No Change	3 Participants	5 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters MCH, Increase to High	0 Participants	1 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters MCV, Decrease to Low	1 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters MCV, Change to Normal or No Change	5 Participants	6 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters MCV, Increase to High	0 Participants	1 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters Erythrocytes, Decrease to Low	0 Participants	1 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters Erythrocytes, Change to Normal or No Change	6 Participants	6 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters Erythrocytes, Increase to High	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters Hematocrit, Decrease to Low	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters Hematocrit, Change to Normal or No Change	5 Participants	7 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters Hematocrit, Increase to High	1 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters Monocytes, Decrease to Low	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters Monocytes, Change to Normal or No Change	3 Participants	4 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters Monocytes, Increase to High	3 Participants	3 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters Reticulocyte, Decrease to Low	4 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters Reticulocyte, Change to Normal or No Change	0 Participants	4 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters Reticulocyte, Increase to High	4 Participants	2 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) and up to approximately 31 months

Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.

Blood samples were collected for the analysis of clinical chemistry parameters: glucose, alanine aminotransferase (ALT), albumin, alkaline phosphatase, aspartate aminotransferase (AST), blood bilirubin, calcium, creatine kinase (CPK), creatinine, gamma glutamyl transferase (GGT), magnesium, phosphate, potassium and sodium. Laboratory parameters were graded according to NCI-CTCAE version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Any worst case post baseline increase in grade along with any increase to a maximum grade of 3 and a maximum grade of 4 are presented.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=6 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation n=7 Participants Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters AST Increased, Increase to Grade 4	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Magnesium Decreased (Hypomagnesemia), Increase to Grade 3	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Phosphate Decreased (Hypophosphatemia), Any Grade Increase	2 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Phosphate Decreased (Hypophosphatemia), Increase to Grade 3	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Magnesium Decreased (Hypomagnesemia), Increase to Grade 4	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Glucose Decreased (Hypoglycemia), Any Grade Increase	1 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Glucose Increased (Hyperglycemia), Any Grade Increase	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Glucose Increased (Hyperglycemia), Increase to Grade 3	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Glucose Increased (Hyperglycemia), Increase to Grade 4	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Glucose Decreased (Hypoglycemia), Increase to Grade 3	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Glucose Decreased (Hypoglycemia), Increase to Grade 4	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters ALT Increased, Any Grade Increase	3 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters ALT Increased, Increase to Grade 3	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters ALT Increased, Increase to Grade 4	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Albumin Decreased (Hypoalbuminemia), Any Grade Increase	1 Participants	4 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Albumin Decreased (Hypoalbuminemia), Increase to Grade 3	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Albumin Decreased (Hypoalbuminemia), Increase to Grade 4	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Alkaline phosphatase Increased, Any Grade Increase	3 Participants	2 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Alkaline phosphatase Increased, Increase to Grade 3	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Alkaline phosphatase Increased, Increase to Grade 4	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters AST Increased, Any Grade Increase	5 Participants	5 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters AST Increased, Increase to Grade 3	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Blood bilirubin Increased, Any Grade Increase	0 Participants	1 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Blood bilirubin Increased, Increase to Grade 3	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Blood bilirubin Increased, Increase to Grade 4	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Calcium Increased (Hypercalcemia), Any Grade Increase	2 Participants	1 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Calcium Increased (Hypercalcemia), Increase to Grade 3	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Calcium Increased (Hypercalcemia), Increase to Grade 4	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Calcium Decreased (Hypocalcemia), Any Grade Increase	2 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Calcium Decreased (Hypocalcemia), Increase to Grade 3	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Calcium Decreased (Hypocalcemia), Increase to Grade 4	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters CPK Increased, Any Grade Increase	1 Participants	2 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters CPK Increased, Increase to Grade 3	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters CPK Increased, Increase to Grade 4	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Creatinine Increased, Any Grade Increase	2 Participants	1 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Creatinine Increased, Increase to Grade 3	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Creatinine Increased, Increase to Grade 4	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters GGT Increased, Any Grade Increase	3 Participants	2 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters GGT Increased, Increase to Grade 3	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters GGT Increased, Increase to Grade 4	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Magnesium Increased (Hypermagnesemia), Any Grade Increase	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Magnesium Increased (Hypermagnesemia), Increase to Grade 3	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Magnesium Increased (Hypermagnesemia), Increase to Grade 4	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Magnesium Decreased (Hypomagnesemia), Any Grade Increase	2 Participants	2 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Phosphate Decreased (Hypophosphatemia), Increase to Grade 4	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Potassium Increased (Hyperkalemia), Any Grade Increase	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Potassium Increased (Hyperkalemia), Increase to Grade 3	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Potassium Increased (Hyperkalemia), Increase to Grade 4	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Potassium Decreased (Hypokalemia), Any Grade Increase	2 Participants	2 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Potassium Decreased (Hypokalemia), Increase to Grade 3	0 Participants	1 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Potassium Decreased (Hypokalemia), Increase to Grade 4	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Sodium Increased (Hypernatremia), Any Grade Increase	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Sodium Increased (Hypernatremia), Increase to Grade 3	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Sodium Increased (Hypernatremia), Increase to Grade 4	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Sodium Decreased (Hyponatremia), Any Grade Increase	1 Participants	3 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Sodium Decreased (Hyponatremia), Increase to Grade 3	0 Participants	2 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Sodium Decreased (Hyponatremia), Increase to Grade 4	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) and up to 31 months

Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.

Blood samples were collected for the analysis of following chemistry parameters: calcium, carbon dioxide, chloride, direct bilirubin, protein, thyrotropin (TSH), thyroxine (T4) and triiodothyronine (T3). The summaries of worst case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=6 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation n=7 Participants Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters Calcium, Decrease to Low	1 Participants	2 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters Calcium, Change to Normal or No Change	4 Participants	4 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters Calcium, Increase to High	1 Participants	1 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters Carbon dioxide, Decrease to Low	2 Participants	1 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters Carbon dioxide, Change to Normal or No Change	3 Participants	4 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters Carbon dioxide, Increase to High	1 Participants	1 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters Chloride, Decrease to Low	1 Participants	2 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters Chloride, Change to Normal or No Change	4 Participants	4 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters Chloride, Increase to High	1 Participants	1 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters Direct bilirubin, Decrease to Low	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters Direct bilirubin, Change to Normal or No Change	4 Participants	5 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters Direct bilirubin, Increase to High	1 Participants	1 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters Protein, Decrease to Low	2 Participants	3 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters Protein, Change to Normal or No Change	3 Participants	4 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters Protein, Increase to High	1 Participants	1 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters TSH, Decrease to Low	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters TSH, Change to Normal or No Change	3 Participants	4 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters TSH, Increase to High	3 Participants	2 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters T4, Decrease to Low	1 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters T4, Change to Normal or No Change	5 Participants	6 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters T4, Increase to High	1 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters T3, Decrease to Low	1 Participants	1 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters T3, Change to Normal or No Change	1 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters T3, Increase to High	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) and up to approximately 31 months

Population: All Treated Population. Only those participants with data available for worst-case post baseline have been presented.

Urine samples were collected to assess urine glucose, protein, occult blood and ketones using dipstick method. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Result for urinalysis parameters were recorded as no change/decreased and any increase. Data for worst-case post baseline urinalysis results is presented.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=6 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation n=7 Participants Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 1 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results Protein, No Change/Decreased	4 Participants	4 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results Protein, Any Increase	2 Participants	2 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results Glucose, No Change/Decreased	6 Participants	5 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results Glucose, Any Increase	0 Participants	1 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results Ketones, No Change/Decreased	3 Participants	5 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results Ketones, Any Increase	3 Participants	1 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results Occult Blood, No Change/Decreased	4 Participants	4 Participants
Part 1 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results Occult Blood, Any Increase	2 Participants	1 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) and Week 46

Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.

Urine samples were collected from participants to assess urine pH levels. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=2 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation n=1 Participants Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 1 - Changes From Baseline in Urine Potential of Hydrogen (pH)	1.0 Potential of Hydrogen (pH) Standard Deviation 2.83	0.0 Potential of Hydrogen (pH)

PRIMARY outcome

Timeframe: Baseline (Day 1) and Week 46

Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.

Urine samples were collected from participants to assess urine specific gravity. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=2 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation n=1 Participants Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 1 - Changes From Baseline in Urine Specific Gravity	-0.0010 Ratio Standard Deviation 0.00566	0.0100 Ratio

PRIMARY outcome

Timeframe: Baseline (Day 1) and up to approximately 31 months

Population: All Treated Population

DBP and SBP were measured after resting for at least 5 minutes in a supine or semi-recumbent position. They were graded according to NCI-CTCAE version 4.03. For SBP: Grade 0 (<=120 millimeter of mercury [mmHg]), Grade 1 (121-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (>=160 mmHg). For DBP: Grade 0 (<=80 mmHg), Grade 1 (81-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (>=100 mmHg). Higher grade indicates greater severity. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post baseline with any grade increase and a maximum post-baseline grade increase to Grade 3 from their baseline grade are presented.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=6 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation n=7 Participants Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) DBP, Any Grade Increase	6 Participants	4 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) DBP, Increase to Grade 2	2 Participants	1 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) DBP, Increase to Grade 3	0 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) SBP, Any Grade Increase	6 Participants	5 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) SBP, Increase to Grade 2	3 Participants	2 Participants
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) SBP, Increase to Grade 3	0 Participants	3 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) and up to approximately 31 months

Population: All Treated Population

Vital signs (pulse rate and temperature) were measured after resting for at least 5 minutes in a supine or semi-recumbent position. The abnormal vital sign ranges were: For pulse rate (low <60 beats per minute [bpm] and high >100 bpm); For body temperature (<=35 degrees Celsius or >=38 degrees Celsius). Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst case change from baseline was presented as Baseline to low, Baseline to Normal or No change and Baseline to High.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=6 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation n=7 Participants Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 1 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature Temperature · Baseline To Normal or No Change	4 Participants	6 Participants
Part 1 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature Temperature · Baseline To High	2 Participants	0 Participants
Part 1 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature Pulse Rate · Baseline To Low	3 Participants	2 Participants
Part 1 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature Pulse Rate · Baseline To Normal or No Change	3 Participants	3 Participants
Part 1 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature Pulse Rate · Baseline To High	0 Participants	2 Participants
Part 1 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature Temperature · Baseline To Low	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Up to approximately 31 months

Population: All Treated Population

ORR was defined as the percentage of participants with a confirmed partial response (PR) or better (i.e., PR, very good partial response [VGPR], complete response [CR] and stringent complete response [sCR]), according to the International Myeloma Working Group (IMWG) Response Criteria. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24 h; PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 h.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=28 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 2 - Percentage of Participants With Overall Response Rate (ORR)	43 Percentage of Participants Interval 24.5 to 62.8	—

SECONDARY outcome

Timeframe: Up to approximately 178 weeks

Population: All Treated Population

ORR was defined as the percentage of participants with a confirmed PR or better (i.e., PR, VGPR, CR and sCR), according to the IMWG Response Criteria. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR >= 90% reduction in serum M-component plus urine M-component <100 mg/24 h; PR = >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to <200 mg/24 h.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=6 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation n=7 Participants Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 1 - Percentage of Participants With Overall Response Rate (ORR)	67 Percentage of Participants Interval 22.3 to 95.7	43 Percentage of Participants Interval 9.9 to 81.6

SECONDARY outcome

Timeframe: Up to approximately 178 weeks

Population: All Treated Population

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=28 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 2 - Number of Participants With AEs and SAEs SAEs	5 Participants	—
Part 2 - Number of Participants With AEs and SAEs AEs	27 Participants	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to approximately 178 weeks

Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.

Blood samples were collected for the analysis of following hematology parameters: hemoglobin, White blood cell (WBC) count, lymphocytes, neutrophils and platelet. The laboratory parameters were graded according to NCI-CTCAE version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Any worst case post baseline increase in grade along with any increase to a maximum grade of 3 and a maximum grade of 4 are presented.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=27 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters Anemia, Any Grade Increase	10 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters Anemia, Increase to Grade 3	3 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters Anemia, Increase to Grade 4	0 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters Hemoglobin increased, Any Grade Increase	2 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters Hemoglobin increased, Increase to Grade 3	0 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters Hemoglobin increased, Increase to Grade 4	0 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters Leukocytosis, Any Grade Increase	1 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters Leukocytosis, Increase to Grade 3	0 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters Leukocytosis, Increase to Grade 4	0 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters WBC decreased, Any Grade Increase	11 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters WBC decreased, Increase to Grade 3	1 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters WBC decreased, Increase to Grade 4	2 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters Lymphocyte count decreased, Any Grade Increase	14 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters Lymphocyte count decreased, Increase to Grade 3	3 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters Lymphocyte count decreased, Increase to Grade 4	4 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters Lymphocyte count increased, Any Grade Increase	2 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters Lymphocyte count increased, Increase to Grade 3	1 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters Lymphocyte count increased, Increase to Grade 4	0 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters Neutrophil count decreased, Any Grade Increase	9 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters Neutrophil count decreased, Increase to Grade 3	1 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters Neutrophil count decreased, Increase to Grade 4	2 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters Platelet count decreased, Any Grade Increase	18 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters Platelet count decreased, Increase to Grade 3	7 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters Platelet count decreased, Increase to Grade 4	4 Participants	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to approximately 178 weeks

Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.

Blood samples were collected for the analysis of following hematology parameters: basophils, eosinophils, mean corpuscular hemoglobin concentration (MCHC), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), Erythrocytes, hematocrit, monocytes, neutrophils and reticulocyte. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=27 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters Basophils, Increase to High	1 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters Eosinophils, Decrease to Low	2 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters Eosinophils, Change to Normal or No Change	22 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters Eosinophils, Increase to High	3 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters MCHC, Decrease to Low	3 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters MCHC, Change to Normal or No Change	24 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters MCHC, Increase to High	0 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters MCH, Decrease to Low	3 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters MCH, Change to Normal or No Change	16 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters MCH, Increase to High	3 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters MCV, Decrease to Low	0 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters MCV, Change to Normal or No Change	25 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters MCV, Increase to High	2 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters Erythrocytes, Decrease to Low	0 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters Erythrocytes, Change to Normal or No Change	26 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters Erythrocytes, Increase to High	1 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters Hematocrit, Decrease to Low	3 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters Hematocrit, Change to Normal or No Change	23 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters Hematocrit, Increase to High	1 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters Monocytes, Decrease to Low	0 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters Monocytes, Change to Normal or No Change	20 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters Monocytes, Increase to High	7 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters Neutrophils, Segmented, Decrease to Low	0 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters Neutrophils, Segmented, Change to Normal or No Change	1 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters Neutrophils, Segmented, Increase to High	0 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters Reticulocytes, Decrease to Low	2 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters Reticulocytes, Change to Normal or No Change	14 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters Reticulocytes, Increase to High	5 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters Basophils, Decrease to Low	0 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters Basophils, Change to Normal or No Change	22 Participants	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to approximately 178 weeks

Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.

Blood samples were collected for the analysis of clinical chemistry parameters: glucose, alanine aminotransferase (ALT), albumin, alkaline phosphatase, aspartate aminotransferase (AST), blood bilirubin, calcium, creatine kinase (CPK), creatinine, gamma glutamyl transferase (GGT), magnesium, phosphate potassium and sodium. Laboratory parameters were graded according to NCI-CTCAE version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Any worst case post baseline increase in grade along with any increase to a maximum grade of 3 and a maximum grade of 4 are presented.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=27 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Creatinine increased, Increase to Grade 4	0 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Hyperglycemia, Any Grade Increase	1 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Hyperglycemia, Increase to Grade 3	0 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Hyperglycemia, Increase to Grade 4	0 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Hypoglycemia, Any Grade Increase	4 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Hypoglycemia, Increase to Grade 3	0 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Hypoglycemia, Increase to Grade 4	0 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters ALT increased, Any Grade Increase	5 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters ALT increased, Increase to Grade 3	1 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters ALT increased, Increase to Grade 4	0 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Hypoalbuminemia, Any Grade Increase	9 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Hypoalbuminemia, Increase to Grade 3	1 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Hypoalbuminemia, Increase to Grade 4	0 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Alkaline phosphatase increased, Any Grade Increase	9 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Alkaline phosphatase increased, Increase to Grade 3	1 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Alkaline phosphatase increased, Increase to Grade 4	0 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters AST increased, Any Grade Increase	20 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters AST increased, Increase to Grade 3	1 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters AST increased, Increase to Grade 4	0 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Blood bilirubin increased, Any Grade Increase	3 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Blood bilirubin increased, Increase to Grade 3	1 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Blood bilirubin increased, Increase to Grade 4	0 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Hypercalcemia, Any Grade Increase	3 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Hypercalcemia, Increase to Grade 3	0 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Hypercalcemia, Increase to Grade 4	0 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Hypocalcemia, Any Grade Increase	3 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Hypocalcemia, Increase to Grade 3	0 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Hypocalcemia, Increase to Grade 4	0 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters CPK increased, Any Grade Increase	4 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters CPK increased, Increase to Grade 3	1 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters CPK increased, Increase to Grade 4	0 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Creatinine increased, Any Grade Increase	7 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Creatinine increased, Increase to Grade 3	0 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters GGT increased, Any Grade Increase	10 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters GGT increased, Increase to Grade 3	1 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters GGT increased, Increase to Grade 4	0 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Hypermagnesemia, Any Grade Increase	0 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Hypermagnesemia, Increase to Grade 3	0 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Hypermagnesemia, Increase to Grade 4	0 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Hypomagnesemia, Any Grade Increase	6 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Hypomagnesemia, Increase to Grade 3	0 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Hypomagnesemia, Increase to Grade 4	0 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Hypophosphatemia, Any Grade Increase	3 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Hypophosphatemia, Increase to Grade 3	1 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Hypophosphatemia, Increase to Grade 4	0 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Hyperkalemia, Any Grade Increase	0 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Hyperkalemia, Increase to Grade 3	0 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Hyperkalemia, Increase to Grade 4	0 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Hypokalemia, Any Grade Increase	4 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Hypokalemia, Increase to Grade 3	1 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Hypokalemia, Increase to Grade 4	0 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Hypernatremia, Any Grade Increase	0 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Hypernatremia, Increase to Grade 3	0 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Hypernatremia, Increase to Grade 4	0 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Hyponatremia, Any Grade Increase	3 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Hyponatremia, Increase to Grade 3	1 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters Hyponatremia, Increase to Grade 4	0 Participants	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to approximately 178 weeks

Population: All Treated Population. Only those participants with data available at specified time points have been analyzed. Participants are counted twice if the participant has values that changed "Decreased to Low" and "Increased to High", so the sum of the percentages may not add to 100% for each row

Blood samples were collected for the analysis of following chemistry parameters: calcium, carbon dioxide, chloride, direct bilirubin, protein, thyrotropin (TSH), thyroxine (T4) and triiodothyronine (T3). Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. The summaries of worst case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. The number of participants with decreases to low, changes to normal or no changes from baseline, and increases to high values have been presented.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=27 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters Calcium, Decrease to Low	4 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters Calcium, Change to Normal or No Change	18 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters Calcium, Increase to High	5 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters Carbon Dioxide, Decrease to Low	4 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters Carbon Dioxide, Change to Normal or No Change	14 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters Carbon Dioxide, Increase to High	9 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters Chloride, Decrease to Low	4 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters Chloride, Change to Normal or No Change	20 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters Chloride, Increase to High	3 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters Direct Bilirubin, Decrease to Low	2 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters Direct Bilirubin, Change to Normal or No Change	15 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters Direct Bilirubin, Increase to High	7 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters Protein, Decrease to Low	8 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters Protein, Change to Normal or No Change	18 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters Protein, Increase to High	2 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters TSH, Decrease to Low	1 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters TSH, Change to Normal or No Change	17 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters TSH, Increase to High	8 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters T4, Free, Decrease to Low	2 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters T4, Free, Change to Normal or No Change	23 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters T4, Free, Increase to High	1 Participants	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to approximately 178 weeks

Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.

Urine samples were collected to assess urine glucose, protein, occult blood and ketones using dipstick method. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Result for uranalysis parameters were recorded as no change/decreased and any increase. Data for worst-case post baseline are presented.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=26 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 2 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results Glucose, No Change/Decreased	25 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results Glucose, Any Increase	1 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results Ketones, No Change/Decreased	21 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results Ketones, Any Increase	5 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results Occult Blood, No Change/Decreased	15 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results Occult Blood, Any Increase	9 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results Protein, No Change/Decreased	20 Participants	—
Part 2 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results Protein, Any Increase	6 Participants	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and until end of treatment (up to 178 weeks)

Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.

Urine samples were collected from participants to assess urine specific gravity. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=25 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 2 - Changes From Baseline in Urine Specific Gravity Baseline	1.0171 Ratio Standard Deviation 0.00965	—
Part 2 - Changes From Baseline in Urine Specific Gravity End of Treatment	-0.0001 Ratio Standard Deviation 0.00813	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and until end of treatment (up to 178 weeks)

Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.

Urine samples were collected from participants to assess urine pH levels. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=28 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 2 - Changes From Baseline in Urine pH Baseline	5.71 Potential of Hydrogen (pH) Standard Deviation 0.844	—
Part 2 - Changes From Baseline in Urine pH End of Treatment	0.10 Potential of Hydrogen (pH) Standard Deviation 0.687	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to approximately 178 weeks

Population: All Treated Population

DBP and SBP were measured after resting for at least 5 minutes in a supine or semi-recumbent position. They were graded according to NCI-CTCAE version 4.0. For SBP: Grade 0 (<=120 millimeter of mercury [mmHg]), Grade 1 (121-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (>=160 mmHg). For DBP: Grade 0 (<=80 mmHg), Grade 1 (81-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (>=100 mmHg). Higher grade indicates greater severity. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. An increase is defined as an increase in grade relative to Baseline grade. Data for worst-case post Baseline with any grade increase and a maximum post-baseline grade increase to Grade 3 from their baseline grade are presented.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=28 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: DBP and SBP DBP, Any Grade Increase	20 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: DBP and SBP DBP, Increase to Grade 2	12 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: DBP and SBP DBP, Increase to Grade 3	2 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: DBP and SBP SBP, Any Grade Increase	24 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: DBP and SBP SBP, Increase to Grade 2	16 Participants	—
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: DBP and SBP SBP, Increase to Grade 3	6 Participants	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to approximately 178 weeks

Population: All Treated Population

Vital signs (pulse rate and temperature) were measured after resting for at least 5 minutes in a supine or semi-recumbent position. The abnormal vital sign ranges were: For pulse rate (low <60 beats per minute [bpm] and high >100 bpm); For body temperature (<=35 degrees Celsius or >=38 degrees Celsius). Participants were counted in the worst case category that their value changed to (low, normal or high), unless there was no change in their category. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=28 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 2 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature Pulse Rate, To Low	10 Participants	—
Part 2 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature Pulse Rate, To Normal or No Change	11 Participants	—
Part 2 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature Pulse Rate, To High	7 Participants	—
Part 2 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature Temperature, To Low	2 Participants	—
Part 2 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature Temperature, To Normal or No Change	23 Participants	—
Part 2 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature Temperature, To High	3 Participants	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to approximately 178 weeks

Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.

BCVA score was calculated based on the Logarithm of the Minimum Angle of Resolution (logMAR score). Any maximum worst-case change from baseline categories are presented for right and left eyes. No change/improved vision is defined as a change from baseline <0.12; a possible worsened vision is defined as a change from baseline >=0.12 to <0.3; a definite worsened vision is defined as a change from baseline >=0.3 logMAR score. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=27 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 2 - Number of Participants With Maximum Worst-case Change From Baseline in Best Corrected Visual Acuity Test (BCVA) Scores Left Eye, No change/improved vision	14 Participants	—
Part 2 - Number of Participants With Maximum Worst-case Change From Baseline in Best Corrected Visual Acuity Test (BCVA) Scores Left Eye, Possible worsened vision	5 Participants	—
Part 2 - Number of Participants With Maximum Worst-case Change From Baseline in Best Corrected Visual Acuity Test (BCVA) Scores Left Eye, Definite worsened vision	8 Participants	—
Part 2 - Number of Participants With Maximum Worst-case Change From Baseline in Best Corrected Visual Acuity Test (BCVA) Scores Right Eye, No change/improved vision	16 Participants	—
Part 2 - Number of Participants With Maximum Worst-case Change From Baseline in Best Corrected Visual Acuity Test (BCVA) Scores Right Eye, Possible worsened vision	4 Participants	—
Part 2 - Number of Participants With Maximum Worst-case Change From Baseline in Best Corrected Visual Acuity Test (BCVA) Scores Right Eye, Definite worsened vision	7 Participants	—

SECONDARY outcome

Timeframe: Up to approximately 178 weeks

Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.

The time for the onset of any visual acuity event (change from baseline logMAR score >= 0.3 in either eye) was calculated.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=10 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 2 - Time Taken for the Onset of First Occurrence of Worsening in BCVA Score	78.0 Days Interval 37.0 to 273.0	—

SECONDARY outcome

Timeframe: Up to approximately 178 weeks

Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.

The onset of any visual acuity event (change from baseline in logMAR score >= 0.3 in either eye) was considered resolved if the change from baseline in logMAR score was less than 0.3 in both eyes. Participants with resolved and not resolved outcome of the worsening eye were presented.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=10 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 2 - Outcome of First Occurrence of Worsening Eye in BCVA Score Resolved prior to end of treatment exposure	7 Participants	—
Part 2 - Outcome of First Occurrence of Worsening Eye in BCVA Score Resolved post end of treatment exposure	2 Participants	—
Part 2 - Outcome of First Occurrence of Worsening Eye in BCVA Score Not resolved	1 Participants	—

SECONDARY outcome

Timeframe: Up to approximately 178 weeks

Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.

The time from onset of any visual acuity event (change from baseline logMAR score >= 0.3 in either eye) until the event is resolved (change from baseline logMAR score < 0.3 in both eyes) was used to calculate the duration of first occurrence.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=9 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 2 - Duration of First Occurrence of Worsening in BCVA Score	47.0 Days Interval 3.0 to 65.0	—

SECONDARY outcome

Timeframe: Up to approximately 178 weeks

Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.

A definite worsened vision was defined as a change from baseline >=0.3 logMAR score.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=10 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 2 - Number of Participants According to the Number of Definite Events of Worsening of Vision One	6 Participants	—
Part 2 - Number of Participants According to the Number of Definite Events of Worsening of Vision Two	1 Participants	—
Part 2 - Number of Participants According to the Number of Definite Events of Worsening of Vision Three or more	3 Participants	—

SECONDARY outcome

Timeframe: Up to approximately 178 weeks

Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.

The event was considered resolved if the change from baseline in logMAR score < 0.3 in both eyes.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=4 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 2 - Number of Participants With Resolution of Post Treatment Exposure Worsening in BCVA Score Resolved	2 Participants	—
Part 2 - Number of Participants With Resolution of Post Treatment Exposure Worsening in BCVA Score Not resolved, follow-up ongoing	0 Participants	—
Part 2 - Number of Participants With Resolution of Post Treatment Exposure Worsening in BCVA Score Not resolved, follow-up ended	2 Participants	—

SECONDARY outcome

Timeframe: Up to approximately 178 weeks

Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.

The time taken for the resolution of worsening eye post treatment exposure. Duration was defined as the time from onset of any visual acuity event (change from baseline logMAR score >= 0.3 in either eye) until the event was considered resolved (change from baseline logMAR score < 0.3 in both eyes). It required at least a one day gap between the resolution of all events from first occurrence to the onset of second occurrence. The end of treatment exposure was defined as 20 days from last infusion date.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=2 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 2 - Duration of Resolution Post-treatment Exposure of Worsening in BCVA Score	34.5 Days Interval 22.0 to 47.0	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to approximately 178 weeks

Population: All Treated Population. Data was not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to approximately 178 weeks

Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.

Participants with worst-case shift from baseline in corneal epithelium defects by right eye, left eye and worse eye are presented as normal (N), abnormal (AN) and missing. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=28 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam Worse Eye · Baseline AN, Post-Baseline AN	7 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam Right Eye · Baseline N, Post-Baseline N	3 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam Right Eye · Baseline N, Post-Baseline AN	16 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam Right Eye · Baseline AN, Post-Baseline N	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam Right Eye · Baseline AN, Post-Baseline AN	8 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam Right Eye · Baseline N, Post-Baseline Missing	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam Right Eye · Baseline AN, Post-Baseline Missing	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam Left Eye · Baseline N, Post-Baseline N	2 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam Left Eye · Baseline N, Post-Baseline AN	16 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam Left Eye · Baseline AN, Post-Baseline N	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam Left Eye · Baseline AN, Post-Baseline AN	8 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam Left Eye · Baseline N, Post-Baseline Missing	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam Left Eye · Baseline AN, Post-Baseline Missing	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam Worse Eye · Baseline N, Post-Baseline N	3 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam Worse Eye · Baseline N, Post-Baseline AN	17 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam Worse Eye · Baseline AN, Post-Baseline N	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam Worse Eye · Baseline N, Post-Baseline Missing	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam Worse Eye · Baseline AN, Post-Baseline Missing	0 Participants	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to approximately 178 weeks

Population: All Treated Population

Participants with worst-case shift from baseline in corneal examination: corneal ulcer, epithelial microcystic edema, subepithelial haze, corneal neovascularization and microcysts without edema, by right eye (R), left eye (L) and worse eye (W) are presented as yes (Y), no (N) and missing (M). Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=28 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Epithelial microcystic edema indicator right eye · Baseline Y, Post-Baseline Missing	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Epithelial microcystic edema indicator right eye · Baseline Missing, Post-Baseline N	3 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal neovascularization indicator left eye · Baseline N, Post-Baseline N	22 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal neovascularization indicator right eye · Baseline Missing, Post-Baseline Missing	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal ulcer indicator left eye · Baseline N, Post-Baseline Missing	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal ulcer indicator left eye · Baseline Y, Post-Baseline N	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal ulcer indicator left eye · Baseline Y, Post-Baseline Y	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal ulcer indicator left eye · Baseline Y, Post-Baseline Missing	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal ulcer indicator left eye · Baseline Missing, Post-Baseline N	3 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal ulcer indicator left eye · Baseline Missing, Post-Baseline Y	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal ulcer indicator left eye · Baseline Missing, Post-Baseline Missing	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal ulcer indicator right eye · Baseline N, Post-Baseline N	21 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal ulcer indicator right eye · Baseline N, Post-Baseline Y	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal ulcer indicator worst eye · Baseline Y, Post-Baseline Y	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal ulcer indicator worst eye · Baseline Y, Post-Baseline Missing	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal ulcer indicator worst eye · Baseline Missing, Post-Baseline N	3 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal ulcer indicator worst eye · Baseline Missing, Post-Baseline Y	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal ulcer indicator right eye · Baseline N, Post-Baseline Missing	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal ulcer indicator right eye · Baseline Y, Post-Baseline N	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal ulcer indicator right eye · Baseline Y, Post-Baseline Y	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal ulcer indicator right eye · Baseline Y, Post-Baseline Missing	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal ulcer indicator right eye · Baseline Missing, Post-Baseline N	5 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal ulcer indicator right eye · Baseline Missing, Post-Baseline Y	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal ulcer indicator right eye · Baseline Missing, Post-Baseline Missing	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal ulcer indicator worst eye · Baseline N, Post-Baseline N	23 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal ulcer indicator worst eye · Baseline N, Post-Baseline Y	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal ulcer indicator worst eye · Baseline N, Post-Baseline Missing	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal ulcer indicator worst eye · Baseline Y, Post-Baseline N	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal ulcer indicator left eye · Baseline N, Post-Baseline N	23 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal ulcer indicator left eye · Baseline N, Post-Baseline Y	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal ulcer indicator worst eye · Baseline Missing, Post-Baseline Missing	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Epithelial microcystic edema indicator left eye · Baseline N, Post-Baseline N	17 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Epithelial microcystic edema indicator left eye · Baseline N, Post-Baseline Y	6 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Epithelial microcystic edema indicator left eye · Baseline N, Post-Baseline Missing	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Epithelial microcystic edema indicator left eye · Baseline Y, Post-Baseline N	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Epithelial microcystic edema indicator left eye · Baseline Y, Post-Baseline Y	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Epithelial microcystic edema indicator left eye · Baseline Y, Post-Baseline Missing	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Epithelial microcystic edema indicator left eye · Baseline Missing, Post-Baseline N	2 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Epithelial microcystic edema indicator left eye · Baseline Missing, Post-Baseline Y	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Epithelial microcystic edema indicator left eye · Baseline Missing, Post-Baseline Missing	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Epithelial microcystic edema indicator right eye · Baseline N, Post-Baseline N	16 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Epithelial microcystic edema indicator right eye · Baseline N, Post-Baseline Y	5 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Epithelial microcystic edema indicator right eye · Baseline N, Post-Baseline Missing	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Epithelial microcystic edema indicator right eye · Baseline Y, Post-Baseline N	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Epithelial microcystic edema indicator right eye · Baseline Y, Post-Baseline Y	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Epithelial microcystic edema indicator right eye · Baseline Missing, Post-Baseline Y	2 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Epithelial microcystic edema indicator right eye · Baseline Missing, Post-Baseline Missing	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Epithelial microcystic edema indicator worst eye · Baseline N, Post-Baseline N	17 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Epithelial microcystic edema indicator worst eye · Baseline N, Post-Baseline Y	6 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Epithelial microcystic edema indicator worst eye · Baseline N, Post-Baseline Missing	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Epithelial microcystic edema indicator worst eye · Baseline Y, Post-Baseline N	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Epithelial microcystic edema indicator worst eye · Baseline Y, Post-Baseline Y	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Epithelial microcystic edema indicator worst eye · Baseline Y, Post-Baseline Missing	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Epithelial microcystic edema indicator worst eye · Baseline Missing, Post-Baseline N	2 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Epithelial microcystic edema indicator worst eye · Baseline Missing, Post-Baseline Y	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Epithelial microcystic edema indicator worst eye · Baseline Missing, Post-Baseline Missing	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Microcysts without edema indicator left eye · Baseline N, Post-Baseline N	8 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Microcysts without edema indicator left eye · Baseline N, Post-Baseline Y	15 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Microcysts without edema indicator left eye · Baseline N, Post-Baseline Missing	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Microcysts without edema indicator left eye · Baseline Y, Post-Baseline N	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Microcysts without edema indicator left eye · Baseline Y, Post-Baseline Y	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Microcysts without edema indicator left eye · Baseline Y, Post-Baseline Missing	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Microcysts without edema indicator left eye · Baseline Missing, Post-Baseline N	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Microcysts without edema indicator left eye · Baseline Missing, Post-Baseline Y	3 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Microcysts without edema indicator left eye · Baseline Missing, Post-Baseline Missing	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Microcysts without edema indicator right eye · Baseline N, Post-Baseline N	7 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Microcysts without edema indicator right eye · Baseline N, Post-Baseline Y	14 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Microcysts without edema indicator right eye · Baseline N, Post-Baseline Missing	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Microcysts without edema indicator right eye · Baseline Y, Post-Baseline N	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Microcysts without edema indicator right eye · Baseline Y, Post-Baseline Y	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Microcysts without edema indicator right eye · Baseline Y, Post-Baseline Missing	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Microcysts without edema indicator right eye · Baseline Missing, Post-Baseline N	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Microcysts without edema indicator right eye · Baseline Missing, Post-Baseline Y	4 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Microcysts without edema indicator right eye · Baseline Missing, Post-Baseline Missing	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Microcysts without edema indicator worst eye · Baseline N, Post-Baseline N	8 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Microcysts without edema indicator worst eye · Baseline N, Post-Baseline Y	15 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Microcysts without edema indicator worst eye · Baseline N, Post-Baseline Missing	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Microcysts without edema indicator worst eye · Baseline Y, Post-Baseline N	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Microcysts without edema indicator worst eye · Baseline Y, Post-Baseline Y	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Microcysts without edema indicator worst eye · Baseline Y, Post-Baseline Missing	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Microcysts without edema indicator worst eye · Baseline Missing, Post-Baseline N	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Microcysts without edema indicator worst eye · Baseline Missing, Post-Baseline Y	3 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Microcysts without edema indicator worst eye · Baseline Missing, Post-Baseline Missing	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal neovascularization indicator left eye · Baseline N, Post-Baseline Y	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal neovascularization indicator left eye · Baseline N, Post-Baseline Missing	2 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal neovascularization indicator left eye · Baseline Y, Post-Baseline N	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal neovascularization indicator left eye · Baseline Y, Post-Baseline Y	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal neovascularization indicator left eye · Baseline Y, Post-Baseline Missing	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal neovascularization indicator left eye · Baseline Missing, Post-Baseline N	2 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal neovascularization indicator left eye · Baseline Missing, Post-Baseline Y	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal neovascularization indicator left eye · Baseline Missing, Post-Baseline Missing	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal neovascularization indicator right eye · Baseline N, Post-Baseline N	20 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal neovascularization indicator right eye · Baseline N, Post-Baseline Y	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal neovascularization indicator right eye · Baseline N, Post-Baseline Missing	2 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal neovascularization indicator right eye · Baseline Y, Post-Baseline N	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal neovascularization indicator right eye · Baseline Y, Post-Baseline Y	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal neovascularization indicator right eye · Baseline Y, Post-Baseline Missing	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal neovascularization indicator right eye · Baseline Missing, Post-Baseline N	3 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal neovascularization indicator right eye · Baseline Missing, Post-Baseline Y	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal neovascularization indicator worst eye · Baseline N, Post-Baseline N	21 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal neovascularization indicator worst eye · Baseline N, Post-Baseline Y	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal neovascularization indicator worst eye · Baseline N, Post-Baseline Missing	2 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal neovascularization indicator worst eye · Baseline Y, Post-Baseline N	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal neovascularization indicator worst eye · Baseline Y, Post-Baseline Y	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal neovascularization indicator worst eye · Baseline Y, Post-Baseline Missing	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal neovascularization indicator worst eye · Baseline Missing, Post-Baseline N	2 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal neovascularization indicator worst eye · Baseline Missing, Post-Baseline Y	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Corneal neovascularization indicator worst eye · Baseline Missing, Post-Baseline Missing	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Subepithelial haze indicator left eye · Baseline N, Post-Baseline N	16 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Subepithelial haze indicator left eye · Baseline N, Post-Baseline Y	9 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Subepithelial haze indicator left eye · Baseline N, Post-Baseline Missing	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Subepithelial haze indicator left eye · Baseline Y, Post-Baseline N	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Subepithelial haze indicator left eye · Baseline Y, Post-Baseline Y	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Subepithelial haze indicator left eye · Baseline Y, Post-Baseline Missing	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Subepithelial haze indicator left eye · Baseline Missing, Post-Baseline N	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Subepithelial haze indicator left eye · Baseline Missing, Post-Baseline Y	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Subepithelial haze indicator left eye · Baseline Missing, Post-Baseline Missing	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Subepithelial haze indicator right eye · Baseline N, Post-Baseline N	16 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Subepithelial haze indicator right eye · Baseline N, Post-Baseline Y	8 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Subepithelial haze indicator right eye · Baseline N, Post-Baseline Missing	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Subepithelial haze indicator right eye · Baseline Y, Post-Baseline N	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Subepithelial haze indicator right eye · Baseline Y, Post-Baseline Y	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Subepithelial haze indicator right eye · Baseline Y, Post-Baseline Missing	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Subepithelial haze indicator right eye · Baseline Missing, Post-Baseline N	2 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Subepithelial haze indicator right eye · Baseline Missing, Post-Baseline Y	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Subepithelial haze indicator right eye · Baseline Missing, Post-Baseline Missing	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Subepithelial haze indicator worst eye · Baseline N, Post-Baseline N	17 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Subepithelial haze indicator worst eye · Baseline N, Post-Baseline Y	9 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Subepithelial haze indicator worst eye · Baseline N, Post-Baseline Missing	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Subepithelial haze indicator worst eye · Baseline Y, Post-Baseline N	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Subepithelial haze indicator worst eye · Baseline Y, Post-Baseline Y	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Subepithelial haze indicator worst eye · Baseline Y, Post-Baseline Missing	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Subepithelial haze indicator worst eye · Baseline Missing, Post-Baseline N	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Subepithelial haze indicator worst eye · Baseline Missing, Post-Baseline Y	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations Subepithelial haze indicator worst eye · Baseline Missing, Post-Baseline Missing	0 Participants	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to approximately 178 weeks

Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.

Participants with worse case punctate keratopathy findings post baseline at any ocular exam by right eye, left eye and worse eye are presented as none, mild, moderate and severe. Worse eye indicates the eye with the worst visual acuity. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=26 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings Right eye, Worst findings · None	2 Participants	—
Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings Right eye, Worst findings · Mild	11 Participants	—
Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings Right eye, Worst findings · Moderate	7 Participants	—
Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings Right eye, Worst findings · Severe	6 Participants	—
Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings Left eye, Worst findings · None	2 Participants	—
Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings Left eye, Worst findings · Mild	9 Participants	—
Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings Left eye, Worst findings · Moderate	9 Participants	—
Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings Left eye, Worst findings · Severe	6 Participants	—
Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings Worst eye, Worst findings · None	2 Participants	—
Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings Worst eye, Worst findings · Mild	8 Participants	—
Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings Worst eye, Worst findings · Moderate	10 Participants	—
Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings Worst eye, Worst findings · Severe	6 Participants	—
Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings Right eye, Most frequent findings · None	10 Participants	—
Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings Right eye, Most frequent findings · Mild	14 Participants	—
Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings Right eye, Most frequent findings · Moderate	2 Participants	—
Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings Right eye, Most frequent findings · Severe	0 Participants	—
Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings Left eye, Most frequent findings · None	8 Participants	—
Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings Left eye, Most frequent findings · Mild	13 Participants	—
Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings Left eye, Most frequent findings · Moderate	5 Participants	—
Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings Left eye, Most frequent findings · Severe	0 Participants	—
Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings Worst eye, Most frequent findings · None	7 Participants	—
Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings Worst eye, Most frequent findings · Mild	14 Participants	—
Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings Worst eye, Most frequent findings · Moderate	5 Participants	—
Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings Worst eye, Most frequent findings · Severe	0 Participants	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to approximately 178 weeks

Population: All Treated Population

Participants with worst-case shift from baseline in corneal examination which included: clear, pseudophakia, nuclear sclerosis, cortical cataract and posterior subcapsular cataract by right eye, left eye and worse eye are presented as yes (Y), no (N) and missing. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=28 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Posterior Subcapsular Cataract, Right eye · Baseline Missing, Post-Baseline Missing	10 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Posterior Subcapsular Cataract, Worse eye · Baseline N, Post-Baseline N	6 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Pseudophakia, Right eye · Baseline Y, Post-Baseline Missing	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Pseudophakia, Right eye · Baseline Missing, Post-Baseline Missing	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Pseudophakia, Worse eye · Baseline N, Post-Baseline Y	4 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Pseudophakia, Worse eye · Baseline N, Post-Baseline N=Missing	3 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Pseudophakia, Worse eye · Baseline Y, Post-Baseline N	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Clear Indicator, Left eye · Baseline N, Post-Baseline N	12 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Clear Indicator, Left eye · Baseline N, Post-Baseline Y	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Clear Indicator, Left eye · Baseline N, Post-Baseline N=Missing	3 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Clear Indicator, Left eye · Baseline Y, Post-Baseline N	3 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Clear Indicator, Left eye · Baseline Y, Post-Baseline Y	10 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Clear Indicator, Left eye · Baseline Y, Post-Baseline Missing	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Clear Indicator, Left eye · Baseline Missing, Post-Baseline N	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Clear Indicator, Left eye · Baseline Missing, Post-Baseline Y	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Clear Indicator, Left eye · Baseline Missing, Post-Baseline Missing	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Clear Indicator, Right eye · Baseline N, Post-Baseline N	12 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Clear Indicator, Right eye · Baseline N, Post-Baseline Y	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Clear Indicator, Right eye · Baseline N, Post-Baseline N=Missing	3 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Clear Indicator, Right eye · Baseline Y, Post-Baseline N	3 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Clear Indicator, Right eye · Baseline Y, Post-Baseline Y	10 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Clear Indicator, Right eye · Baseline Y, Post-Baseline Missing	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Clear Indicator, Right eye · Baseline Missing, Post-Baseline N	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Clear Indicator, Right eye · Baseline Missing, Post-Baseline Y	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Clear Indicator, Right eye · Baseline Missing, Post-Baseline Missing	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Clear Indicator, worse eye · Baseline N, Post-Baseline N	12 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Clear Indicator, worse eye · Baseline N, Post-Baseline Y	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Clear Indicator, worse eye · Baseline N, Post-Baseline N=Missing	3 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Clear Indicator, worse eye · Baseline Y, Post-Baseline N	3 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Clear Indicator, worse eye · Baseline Y, Post-Baseline Y	10 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Clear Indicator, worse eye · Baseline Y, Post-Baseline Missing	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Clear Indicator, worse eye · Baseline Missing, Post-Baseline N	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Clear Indicator, worse eye · Baseline Missing, Post-Baseline Y	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Clear Indicator, worse eye · Baseline Missing, Post-Baseline Missing	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Cortical Cataract Indicator, Left eye · Baseline N, Post-Baseline N	7 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Cortical Cataract Indicator, Left eye · Baseline N, Post-Baseline Y	3 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Cortical Cataract Indicator, Left eye · Baseline N, Post-Baseline N=Missing	2 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Cortical Cataract Indicator, Left eye · Baseline Y, Post-Baseline N	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Cortical Cataract Indicator, Left eye · Baseline Y, Post-Baseline Y	2 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Cortical Cataract Indicator, Left eye · Baseline Y, Post-Baseline Missing	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Cortical Cataract Indicator, Left eye · Baseline Missing, Post-Baseline N	2 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Cortical Cataract Indicator, Left eye · Baseline Missing, Post-Baseline Y	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Cortical Cataract Indicator, Left eye · Baseline Missing, Post-Baseline Missing	10 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Cortical Cataract Indicator, Right eye · Baseline N, Post-Baseline N	7 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Cortical Cataract Indicator, Right eye · Baseline N, Post-Baseline Y	3 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Cortical Cataract Indicator, Right eye · Baseline N, Post-Baseline N=Missing	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Cortical Cataract Indicator, Right eye · Baseline Y, Post-Baseline N	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Cortical Cataract Indicator, Right eye · Baseline Y, Post-Baseline Y	2 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Cortical Cataract Indicator, Right eye · Baseline Y, Post-Baseline Missing	2 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Cortical Cataract Indicator, Right eye · Baseline Missing, Post-Baseline N	3 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Cortical Cataract Indicator, Right eye · Baseline Missing, Post-Baseline Y	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Cortical Cataract Indicator, Right eye · Baseline Missing, Post-Baseline Missing	10 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Cortical Cataract Indicator, Worse eye · Baseline N, Post-Baseline N	7 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Cortical Cataract Indicator, Worse eye · Baseline N, Post-Baseline Y	3 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Cortical Cataract Indicator, Worse eye · Baseline N, Post-Baseline N=Missing	2 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Cortical Cataract Indicator, Worse eye · Baseline Y, Post-Baseline N	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Cortical Cataract Indicator, Worse eye · Baseline Y, Post-Baseline Y	2 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Cortical Cataract Indicator, Worse eye · Baseline Y, Post-Baseline Missing	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Cortical Cataract Indicator, Worse eye · Baseline Missing, Post-Baseline N	2 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Cortical Cataract Indicator, Worse eye · Baseline Missing, Post-Baseline Y	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Cortical Cataract Indicator, Worse eye · Baseline Missing, Post-Baseline Missing	10 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Nuclear Sclerosis, Left eye · Baseline N, Post-Baseline N	2 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Nuclear Sclerosis, Left eye · Baseline N, Post-Baseline Y	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Nuclear Sclerosis, Left eye · Baseline N, Post-Baseline N=Missing	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Nuclear Sclerosis, Left eye · Baseline Y, Post-Baseline N	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Nuclear Sclerosis, Left eye · Baseline Y, Post-Baseline Y	8 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Nuclear Sclerosis, Left eye · Baseline Y, Post-Baseline Missing	3 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Nuclear Sclerosis, Left eye · Baseline Missing, Post-Baseline N	2 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Nuclear Sclerosis, Left eye · Baseline Missing, Post-Baseline Y	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Nuclear Sclerosis, Left eye · Baseline Missing, Post-Baseline Missing	10 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Nuclear Sclerosis, Right eye · Baseline N, Post-Baseline N	2 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Nuclear Sclerosis, Right eye · Baseline N, Post-Baseline Y	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Nuclear Sclerosis, Right eye · Baseline N, Post-Baseline N=Missing	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Nuclear Sclerosis, Right eye · Baseline Y, Post-Baseline N	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Nuclear Sclerosis, Right eye · Baseline Y, Post-Baseline Y	8 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Nuclear Sclerosis, Right eye · Baseline Y, Post-Baseline Missing	3 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Nuclear Sclerosis, Right eye · Baseline Missing, Post-Baseline N	3 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Nuclear Sclerosis, Right eye · Baseline Missing, Post-Baseline Y	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Nuclear Sclerosis, Right eye · Baseline Missing, Post-Baseline Missing	10 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Nuclear Sclerosis, Worse eye · Baseline N, Post-Baseline N	2 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Nuclear Sclerosis, Worse eye · Baseline N, Post-Baseline Y	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Nuclear Sclerosis, Worse eye · Baseline N, Post-Baseline N=Missing	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Nuclear Sclerosis, Worse eye · Baseline Y, Post-Baseline N	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Nuclear Sclerosis, Worse eye · Baseline Y, Post-Baseline Y	8 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Nuclear Sclerosis, Worse eye · Baseline Y, Post-Baseline Missing	3 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Nuclear Sclerosis, Worse eye · Baseline Missing, Post-Baseline N	2 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Nuclear Sclerosis, Worse eye · Baseline Missing, Post-Baseline Y	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Nuclear Sclerosis, Worse eye · Baseline Missing, Post-Baseline Missing	10 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Posterior Subcapsular Cataract, Left eye · Baseline N, Post-Baseline N	7 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Posterior Subcapsular Cataract, Left eye · Baseline N, Post-Baseline Y	3 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Posterior Subcapsular Cataract, Left eye · Baseline N, Post-Baseline N=Missing	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Posterior Subcapsular Cataract, Left eye · Baseline Y, Post-Baseline N	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Posterior Subcapsular Cataract, Left eye · Baseline Y, Post-Baseline Y	2 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Posterior Subcapsular Cataract, Left eye · Baseline Y, Post-Baseline Missing	3 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Posterior Subcapsular Cataract, Left eye · Baseline Missing, Post-Baseline N	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Posterior Subcapsular Cataract, Left eye · Baseline Missing, Post-Baseline Y	2 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Posterior Subcapsular Cataract, Left eye · Baseline Missing, Post-Baseline Missing	10 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Posterior Subcapsular Cataract, Right eye · Baseline N, Post-Baseline N	7 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Posterior Subcapsular Cataract, Right eye · Baseline N, Post-Baseline Y	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Posterior Subcapsular Cataract, Right eye · Baseline N, Post-Baseline N=Missing	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Posterior Subcapsular Cataract, Right eye · Baseline Y, Post-Baseline N	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Posterior Subcapsular Cataract, Right eye · Baseline Y, Post-Baseline Y	4 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Posterior Subcapsular Cataract, Right eye · Baseline Y, Post-Baseline Missing	3 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Posterior Subcapsular Cataract, Right eye · Baseline Missing, Post-Baseline N	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Posterior Subcapsular Cataract, Right eye · Baseline Missing, Post-Baseline Y	2 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Posterior Subcapsular Cataract, Worse eye · Baseline N, Post-Baseline Y	3 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Posterior Subcapsular Cataract, Worse eye · Baseline N, Post-Baseline N=Missing	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Posterior Subcapsular Cataract, Worse eye · Baseline Y, Post-Baseline N	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Posterior Subcapsular Cataract, Worse eye · Baseline Y, Post-Baseline Y	4 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Posterior Subcapsular Cataract, Worse eye · Baseline Y, Post-Baseline Missing	3 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Posterior Subcapsular Cataract, Worse eye · Baseline Missing, Post-Baseline N	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Posterior Subcapsular Cataract, Worse eye · Baseline Missing, Post-Baseline Y	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Posterior Subcapsular Cataract, Worse eye · Baseline Missing, Post-Baseline Missing	10 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Pseudophakia, Left eye · Baseline N, Post-Baseline N	11 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Pseudophakia, Left eye · Baseline N, Post-Baseline Y	3 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Pseudophakia, Left eye · Baseline N, Post-Baseline N=Missing	3 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Pseudophakia, Left eye · Baseline Y, Post-Baseline N	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Pseudophakia, Left eye · Baseline Y, Post-Baseline Y	10 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Pseudophakia, Left eye · Baseline Y, Post-Baseline Missing	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Pseudophakia, Left eye · Baseline Missing, Post-Baseline N	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Pseudophakia, Left eye · Baseline Missing, Post-Baseline Y	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Pseudophakia, Left eye · Baseline Missing, Post-Baseline Missing	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Pseudophakia, Right eye · Baseline N, Post-Baseline N	12 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Pseudophakia, Right eye · Baseline N, Post-Baseline Y	2 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Pseudophakia, Right eye · Baseline N, Post-Baseline N=Missing	3 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Pseudophakia, Right eye · Baseline Y, Post-Baseline N	1 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Pseudophakia, Right eye · Baseline Y, Post-Baseline Y	10 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Pseudophakia, Right eye · Baseline Missing, Post-Baseline N	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Pseudophakia, Right eye · Baseline Missing, Post-Baseline Y	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Pseudophakia, Worse eye · Baseline N, Post-Baseline N	11 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Pseudophakia, Worse eye · Baseline Y, Post-Baseline Y	10 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Pseudophakia, Worse eye · Baseline Y, Post-Baseline Missing	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Pseudophakia, Worse eye · Baseline Missing, Post-Baseline N	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Pseudophakia, Worse eye · Baseline Missing, Post-Baseline Y	0 Participants	—
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations Pseudophakia, Worse eye · Baseline Missing, Post-Baseline Missing	0 Participants	—

SECONDARY outcome

Timeframe: Up to approximately 178 weeks

Population: All Treated Population

Clinical benefit rate was defined as the percentage of participants with a confirmed minimal response (MR) or better according to the IMWG Response Criteria. MR is >= 25% but < 49% reduction of serum M-protein and reduction in 24-hour urinary M-protein by 50-89%.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=28 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 2 - Percentage of Participants With Clinical Benefit Rate	43 Percentage of Participants Interval 24.5 to 62.8	—

SECONDARY outcome

Timeframe: Up to approximately 178 weeks

Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.

Duration of response was defined as the time from first documented evidence of PR or better, to the time when disease progression (PD) is documented per IMWG response criteria; or death due to PD occurs among participants who achieve an overall response, i.e. confirmed PR or better. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of >= 0.5 g/dL; Serum M-protein increase >= 1 g/dL if the lowest M-component was >=5 g/dL; Urinary M-protein (absolute increase must be >= 200 mg per 24 h). PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to <200 mg/24 h.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=12 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 2 - Duration of Response	7.6 Months Interval 1.4 to The upper limit of 95% CI was not estimate due to limited number of events	—

SECONDARY outcome

Timeframe: Up to approximately 178 weeks

Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.

Time to response (TTR) was defined as the time between the date of first dose and the first documented evidence of response (PR or better) among participants who achieved a confirmed response of PR or better.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=12 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 2 - Time to Response	0.7 Months Interval 0.7 to 1.4	—

SECONDARY outcome

Timeframe: Up to approximately 178 weeks

Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.

Time to best response was defined as the time between the date of first dose and the first best documented response (PR or better) among participants who achieved a confirmed response of PR or better.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=12 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 2 - Time to Best Response	1.7 Months Interval 0.7 to 5.6	—

SECONDARY outcome

Timeframe: Up to approximately 178 weeks

Population: All Treated Population

Progression-free survival was defined as the time from first dose until the earliest date of PD per IMWG response criteria, or death due to any cause. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of >= 0.5 g/dL; Serum M-protein increase >= 1 g/dL if the lowest M-component was >=5 g/dL; Urinary M-protein (absolute increase must be >= 200 mg per 24 h).

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=28 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 2 - Progression-free Survival	2.5 Months Interval 0.8 to 5.6	—

SECONDARY outcome

Timeframe: Up to approximately 178 weeks

Population: All Treated Population

Time to disease progression was defined as the time from first dose until the earliest date of PD per IMWG response criteria, or death due to PD. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of >= 0.5 g/dL; Serum M-protein increase >= 1 g/dL if the lowest M-component was >=5 g/dL; Urinary M-protein (absolute increase must be >= 200 mg per 24 h).

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=28 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 2 - Time to Disease Progression	2.5 Months Interval 0.8 to 5.6	—

SECONDARY outcome

Timeframe: Up to approximately 178 weeks

Population: All Treated Population

Overall Survival was defined as the time from first dose until death due to any cause.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=28 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 2 - Overall Survival	NA Months Interval 19.1 to The median and upper limit of 95% CI was not estimate due to limited number of events	—

SECONDARY outcome

Timeframe: Pre-dose, end of infusion (EOI), 2, 4, 9, and 24 h post-SOI (start of infusion) on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Population: Pharmacokinetic (PK) Population included participants in the all treated population from whom at least one PK sample was obtained and analyzed for belantamab mafodotin. Due to bioanalytical issues, PK data were not collected and analyzed for belantamab mafodotin. Therefore, this PK parameter was not reported in this study.

Blood samples were collected for Pharmacokinetic (PK) analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Population: Pharmacokinetic Population. Due to bioanalytical issues, PK data were not collected and analyzed for belantamab mafodotin. Therefore, this PK parameter was not reported in this study

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: EOI post belantamab mafodotin dose on Day 1 of each 21 day Cycle till Cycle 11

Population: Pharmacokinetic Population. Due to bioanalytical issues, PK data were not collected and analyzed for belantamab mafodotin. Therefore, this PK parameter was not reported in this study

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: EOI post belantamab mafodotin dose on Day 1 of each 21 day Cycle till Cycle 11

Population: Pharmacokinetic Population. Due to bioanalytical issues, PK data were not collected and analyzed for belantamab mafodotin. Therefore, this PK parameter was not reported in this study

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Population: Pharmacokinetic Population. Due to bioanalytical issues, PK data were not collected and analyzed for belantamab mafodotin. Therefore, this PK parameter was not reported in this study

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Population: Pharmacokinetic Population. Due to bioanalytical issues, PK data were not collected and analyzed for belantamab mafodotin. Therefore, this PK parameter was not reported in this study

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose on Day 1 of each 21 day cycle from Cycle 1 until Cycle 13

Population: Pharmacokinetic Population. Due to bioanalytical issues, PK data were not collected and analyzed for belantamab mafodotin. Therefore, this PK parameter was not reported in this study

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. Ctrough was calculated as the observed concentration at the end of a dosing interval, immediately before next study drug administration on Day 1 of each Cycle. PK parameter was determined using standard non-compartmental methods.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose on Day 1 of each 21 day cycle from Cycle 1 until Cycle 13

Population: Pharmacokinetic Population. Due to bioanalytical issues, PK data were not collected and analyzed for belantamab mafodotin. Therefore, this PK parameter was not reported in this study

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. Ctrough was calculated as the observed concentration at the end of a dosing interval, immediately before next study drug administration on Day 1 of each Cycle. PK parameter was determined using standard non-compartmental methods.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Population: Pharmacokinetic Population. Due to bioanalytical issues, PK data were not collected and analyzed for belantamab mafodotin. Therefore, this PK parameter was not reported in this study

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Population: Pharmacokinetic Population. Due to bioanalytical issues, PK data were not collected and analyzed for belantamab mafodotin. Therefore, this PK parameter was not reported in this study

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Population: Pharmacokinetic Population. Due to bioanalytical issues, PK data were not collected and analyzed for belantamab mafodotin. Therefore, this PK parameter was not reported in this study

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Population: Pharmacokinetic Population. Due to bioanalytical issues, PK data were not collected and analyzed for belantamab mafodotin. Therefore, this PK parameter was not reported in this study

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=4 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation n=7 Participants Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 1 - Cmax for Total Monoclonal Antibody (mAb) After First Dose	43.57 ug/mL Geometric Coefficient of Variation 7.1	64.45 ug/mL Geometric Coefficient of Variation 21.5

SECONDARY outcome

Timeframe: Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=26 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 2 - Cmax for Total mAb After First Dose	46.70 ug/mL Geometric Coefficient of Variation 23.3	—

SECONDARY outcome

Timeframe: EOI post belantamab mafodotin dose on Day 1 of Cycle 1, Cycle 2, Cycle 5, Cycle 8, and Cycle 11

Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=4 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation n=7 Participants Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 1 - C-EOI for Total mAb Cycle 1	40.15 ug/mL Interval 36.3 to 44.4	65.30 ug/mL Interval 44.6 to 73.5
Part 1 - C-EOI for Total mAb Cycle 2	53.90 ug/mL Interval 39.1 to 66.3	64.65 ug/mL Interval 16.1 to 90.1
Part 1 - C-EOI for Total mAb Cycle 5	54.65 ug/mL Interval 46.5 to 78.2	73.90 ug/mL Interval 42.6 to 101.0
Part 1 - C-EOI for Total mAb Cycle 8	63.70 ug/mL Interval 63.7 to 63.7	39.75 ug/mL Interval 12.9 to 66.6
Part 1 - C-EOI for Total mAb Cycle 11	65.40 ug/mL Interval 65.4 to 65.4	54.80 ug/mL Interval 54.8 to 54.8

SECONDARY outcome

Timeframe: EOI post belantamab mafodotin dose on Day 1 of Cycle 1, Cycle 2, and Cycle 5

Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=23 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 2 - C-EOI for Total mAb Cycle 1	48.60 ug/mL Interval 17.4 to 68.9	—
Part 2 - C-EOI for Total mAb Cycle 2	53.00 ug/mL Interval 26.5 to 71.1	—
Part 2 - C-EOI for Total mAb Cycle 5	52.35 ug/mL Interval 36.9 to 70.5	—

SECONDARY outcome

Timeframe: Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=4 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation n=7 Participants Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 1 - Tmax for Total mAb After First Dose	1.100 Hour Interval 0.53 to 2.18	1.520 Hour Interval 0.75 to 2.05

SECONDARY outcome

Timeframe: Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=26 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 2 - Tmax for Total mAb After First Dose	0.945 Hour Interval 0.47 to 2.33	—

SECONDARY outcome

Timeframe: Cycle 1, Cycle 4, Cycle 7, Cycle 10, and Cycle 13

Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. Ctrough was calculated as the observed concentration at the end of a dosing interval, immediately before next study drug administration on Day 1 of each Cycle. PK parameter was determined using standard non-compartmental methods.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=5 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation n=4 Participants Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 1 - Ctrough for Total mAb Cycle 1	5.420 ug/mL Interval 3.85 to 7.87	13.350 ug/mL Interval 1.83 to 13.5
Part 1 - Ctrough for Total mAb Cycle 4	8.91 ug/mL Interval 0.0 to 30.8	18.80 ug/mL Interval 18.1 to 19.5
Part 1 - Ctrough for Total mAb Cycle 7	26.90 ug/mL Interval 26.9 to 26.9	45.05 ug/mL Interval 23.9 to 66.2
Part 1 - Ctrough for Total mAb Cycle 10	18.40 ug/mL Interval 18.4 to 18.4	21.70 ug/mL Interval 21.7 to 21.7
Part 1 - Ctrough for Total mAb Cycle 13	18.05 ug/mL Interval 18.0 to 18.1	—

SECONDARY outcome

Timeframe: Cycle 1 and Cycle 4

Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. Ctrough was calculated as the observed concentration at the end of a dosing interval, immediately before next study drug administration on Day 1 of each Cycle. PK parameter was determined using standard non-compartmental methods.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=20 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 2 - Ctrough for Total mAb Cycle 1	7.735 ug/mL Interval 1.28 to 12.7	—
Part 2 - Ctrough for Total mAb Cycle 4	11.60 ug/mL Interval 9.15 to 31.0	—

SECONDARY outcome

Timeframe: Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. Tlast is the time of last observed quantifiable concentration of belantamab mafodotin in Cycle 1 which extended beyond protocol defined duration for some participants across treatment groups.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=5 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation n=7 Participants Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 1 - Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) for Total mAb After First Dose	501.800 Hour Interval 70.03 to 507.23	481.580 Hour Interval 72.27 to 551.8

SECONDARY outcome

Timeframe: Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Population: Pharmacokinetic Population

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. Tlast is the time of last observed quantifiable concentration of belantamab mafodotin in Cycle 1 which extended beyond protocol defined duration for some participants across treatment groups.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=28 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 2 - Tlast for Total mAb After First Dose	503.140 Hour Interval 72.5 to 2060.68	—

SECONDARY outcome

Timeframe: Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=3 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation n=4 Participants Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 1 - AUC (0-tau) for Total mAb After First Dose	6237.2 h*ug/mL Geometric Coefficient of Variation 17.9	10817.8 h*ug/mL Geometric Coefficient of Variation 48.5

SECONDARY outcome

Timeframe: Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=19 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 2 - AUC (0-tau) for Total mAb After First Dose	7949.0 h*ug/mL Geometric Coefficient of Variation 27.2	—

SECONDARY outcome

Timeframe: Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=2 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation n=5 Participants Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 1 - Cmax for Cysteine Maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) After First Dose	1.5799 ng/mL Geometric Coefficient of Variation 30.4	1.0966 ng/mL Geometric Coefficient of Variation 40.9

SECONDARY outcome

Timeframe: Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=26 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 2 - Cmax for Cys-mcMMAF After First Dose	1.2481 ng/mL Geometric Coefficient of Variation 111.5	—

SECONDARY outcome

Timeframe: EOI post belantamab mafodotin dose on Day 1 of Cycle 1

Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=2 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation n=7 Participants Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 1 - C-EOI for Cys-mcMMAF After First Dose	0.7110 ng/mL Interval 0.342 to 1.08	0.7630 ng/mL Interval 0.169 to 1.98

SECONDARY outcome

Timeframe: EOI post belantamab mafodotin dose on Day 1 of Cycle 1

Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=25 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 2 - C-EOI for Cys-mcMMAF After First Dose	0.3150 ng/mL Interval 0.131 to 20.3	—

SECONDARY outcome

Timeframe: Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. Tlast is the time of last observed quantifiable concentration of belantamab mafodotin in Cycle 1 which extended beyond protocol defined duration for some participants across treatment groups.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=2 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation n=5 Participants Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 1 - Tmax for Cys-mcMMAF After First Dose	13.510 Hour Interval 4.05 to 22.97	4.120 Hour Interval 0.57 to 73.03

SECONDARY outcome

Timeframe: Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. Tlast is the time of last observed quantifiable concentration of belantamab mafodotin in Cycle 1 which extended beyond protocol defined duration for some participants across treatment groups.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=26 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 2 - Tmax for Cys-mcMMAF After First Dose	23.580 Hour Interval 0.52 to 70.65	—

SECONDARY outcome

Timeframe: Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. Tlast is the time of last observed quantifiable concentration of belantamab mafodotin in Cycle 1 which extended beyond protocol defined duration for some participants across treatment groups.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=3 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation n=7 Participants Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 1 - Tlast for Cys-mcMMAF After First Dose	161.380 Hour Interval 70.03 to 168.13	171.250 Hour Interval 72.27 to 501.28

SECONDARY outcome

Timeframe: Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Population: Pharmacokinetic Population

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. Tlast is the time of last observed quantifiable concentration of belantamab mafodotin in Cycle 1 which extended beyond protocol defined duration for some participants across treatment groups.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=28 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 2 - Tlast for Cys-mcMMAF After First Dose	167.510 Hour Interval 23.9 to 503.15	—

SECONDARY outcome

Timeframe: Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, and Cycle 1 Day 8

Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=1 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation n=4 Participants Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 1 - AUC From Time 0 to 168 h After Dosing [AUC (0-168h)] for Cys-mcMMAF After First Dose	155.27 h*ug/mL	90.61 h*ug/mL Geometric Coefficient of Variation 34.5

SECONDARY outcome

Timeframe: Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, and Cycle 1 Day 8

Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=18 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 2 - AUC (0-168 h) for Cys-mcMMAF After First Dose	128.38 h*ug/mL Geometric Coefficient of Variation 70.9	—

SECONDARY outcome

Timeframe: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Population: Pharmacokinetic Population. Pembrolizumab data were not collected and analyzed. Therefore, this PK parameter was not reported in this study.

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Population: Pharmacokinetic Population. Pembrolizumab data were not collected and analyzed. Therefore, this PK parameter was not reported in this study.

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Population: Pharmacokinetic Population. Pembrolizumab data were not collected and analyzed. Therefore, this PK parameter was not reported in this study.

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Population: Pharmacokinetic Population. Pembrolizumab data were not collected and analyzed. Therefore, this PK parameter was not reported in this study.

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Population: Pharmacokinetic Population. Pembrolizumab data were not collected and analyzed. Therefore, this PK parameter was not reported in this study.

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Population: Pharmacokinetic Population. Pembrolizumab data were not collected and analyzed. Therefore, this PK parameter was not reported in this study.

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (Day 1) and until end of treatment (up to 178 weeks)

Population: All Treated Population

Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were tested in screening assay, and positive samples were further characterized for antibody titers. At the time of primary results posting, there was no participants with positive ADA results. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=4 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation n=7 Participants Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 1 - Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin Baseline	0 Participants	0 Participants
Part 1 - Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin End of Treatment	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and until end of treatment (up to 178 weeks)

Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.

Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were tested in screening assay, and positive samples were further characterized for antibody titers. At the time of primary results posting, there was no participants with positive ADA results. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.

Outcome measures

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=27 Participants Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
Part 2 - Number of Participants With Post-baseline Positive ADAs Against Belantamab Mafodotin Baseline	0 Participants	—
Part 2 - Number of Participants With Post-baseline Positive ADAs Against Belantamab Mafodotin End of Treatment	0 Participants	—

SECONDARY outcome

Timeframe: Up to approximately 178 weeks

Population: All Treated Population. There were no participants with positive ADA results. Hence the titer (concentration) of ADA was not collected.

Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were to be further tested in screening assay, and positive samples were further to be characterized for antibody titers.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to approximately 178 weeks

Population: All Treated Population. There were no participants with positive ADA results. Hence the titer (concentration) of ADA was not collected.

Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were to be further tested in screening assay, and positive samples were further to be characterized for antibody titers.

Outcome measures

Outcome data not reported

Adverse Events

Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation

Serious events: 4 serious events

Other events: 6 other events

Deaths: 2 deaths

Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation

Serious events: 5 serious events

Other events: 6 other events

Deaths: 3 deaths

Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion

Serious events: 5 serious events

Other events: 27 other events

Deaths: 7 deaths

PACT Phase- Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=6 participants at risk Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation n=7 participants at risk Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion n=28 participants at risk Participants were administered belantamab mafodotin with recommended phase 2 dose (RP2D) of 2.5 mg/kg in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.	PACT Phase- Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg n=2 participants at risk Participants who completed approximately 178 weeks of treatment of 2.5 mg/kg belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion had the opportunity to continue receiving belantamab mafodotin in the PACT phase up to approximately 221 weeks.
Blood and lymphatic system disorders Febrile neutropenia	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/28 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Cardiac disorders Atrial flutter	0.00% 0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	3.6% 1/28 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Cardiac disorders Cardiac failure congestive	0.00% 0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	3.6% 1/28 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Cardiac disorders Cardiopulmonary failure	0.00% 0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/28 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Gastrointestinal disorders Large intestinal haemorrhage	0.00% 0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/28 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
General disorders Chest pain	0.00% 0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	3.6% 1/28 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Immune system disorders Anaphylactic reaction	0.00% 0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/28 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Immune system disorders Cytokine release syndrome	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/28 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Infections and infestations Bacteraemia	0.00% 0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	3.6% 1/28 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Infections and infestations Infection	0.00% 0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	7.1% 2/28 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Infections and infestations Leishmaniasis	0.00% 0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/28 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Infections and infestations Pneumonia	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	14.3% 1/7 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	14.3% 4/28 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Infections and infestations Pneumonia haemophilus	0.00% 0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/28 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Infections and infestations Sepsis	0.00% 0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	3.6% 1/28 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Infections and infestations Urinary tract infection	33.3% 2/6 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/28 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Femur fracture	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/28 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Infusion related reaction	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	7.1% 2/28 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/28 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Investigations Platelet count decreased	0.00% 0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	3.6% 1/28 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	3.6% 1/28 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/28 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasmacytoma	0.00% 0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	3.6% 1/28 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Psychiatric disorders Mental status changes	0.00% 0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	3.6% 1/28 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Renal and urinary disorders Acute kidney injury	0.00% 0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/28 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Renal and urinary disorders Renal failure	0.00% 0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	3.6% 1/28 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	3.6% 1/28 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
General disorders Pyrexia	0.00% 0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/28 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.

Other adverse events

Measure	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation n=6 participants at risk Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation n=7 participants at risk Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion n=28 participants at risk Participants were administered belantamab mafodotin with recommended phase 2 dose (RP2D) of 2.5 mg/kg in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.	PACT Phase- Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg n=2 participants at risk Participants who completed approximately 178 weeks of treatment of 2.5 mg/kg belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion had the opportunity to continue receiving belantamab mafodotin in the PACT phase up to approximately 221 weeks.
Blood and lymphatic system disorders Anaemia	66.7% 4/6 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	42.9% 3/7 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	17.9% 5/28 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Neutropenia	33.3% 2/6 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	28.6% 2/7 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	7.1% 2/28 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Thrombocytopenia	50.0% 3/6 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	42.9% 3/7 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	32.1% 9/28 • Number of events 10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Eye disorders Blepharitis	50.0% 3/6 • Number of events 7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/28 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Eye disorders Dry eye	50.0% 3/6 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	14.3% 1/7 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	14.3% 4/28 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Eye disorders Eye pruritus	33.3% 2/6 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/28 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Eye disorders Keratopathy	100.0% 6/6 • Number of events 7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	85.7% 6/7 • Number of events 7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	71.4% 20/28 • Number of events 27 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Eye disorders Photophobia	33.3% 2/6 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	10.7% 3/28 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Eye disorders Vision blurred	50.0% 3/6 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	28.6% 2/7 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	35.7% 10/28 • Number of events 10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Gastrointestinal disorders Constipation	0.00% 0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	14.3% 1/7 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	7.1% 2/28 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Gastrointestinal disorders Diarrhoea	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	7.1% 2/28 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Gastrointestinal disorders Nausea	50.0% 3/6 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	14.3% 1/7 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	25.0% 7/28 • Number of events 7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Gastrointestinal disorders Vomiting	0.00% 0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	10.7% 3/28 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
General disorders Fatigue	50.0% 3/6 • Number of events 9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	42.9% 3/7 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	10.7% 3/28 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
General disorders Pyrexia	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	57.1% 4/7 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	35.7% 10/28 • Number of events 12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Infections and infestations Pneumonia	0.00% 0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	7.1% 2/28 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Infections and infestations Urinary tract infection	16.7% 1/6 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	28.6% 2/7 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/28 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Infusion related reaction	33.3% 2/6 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	25.0% 7/28 • Number of events 7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Investigations Alanine aminotransferase increased	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	10.7% 3/28 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Investigations Aspartate aminotransferase increased	33.3% 2/6 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	14.3% 4/28 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Investigations Visual acuity tests abnormal	16.7% 1/6 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	14.3% 1/7 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	3.6% 1/28 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Investigations Weight decreased	0.00% 0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	28.6% 2/7 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	3.6% 1/28 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hypokalaemia	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	7.1% 2/28 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	28.6% 2/7 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	3.6% 1/28 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	10.7% 3/28 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	7.1% 2/28 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	16.7% 1/6 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	7.1% 2/28 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Nervous system disorders Headache	33.3% 2/6 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	28.6% 2/7 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	3.6% 1/28 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Psychiatric disorders Insomnia	0.00% 0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	14.3% 1/7 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	7.1% 2/28 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Cough	50.0% 3/6 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	28.6% 2/7 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	7.1% 2/28 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	33.3% 2/6 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	7.1% 2/28 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	7.1% 2/28 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Pruritus	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	7.1% 2/28 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.
Vascular disorders Hypertension	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	28.6% 2/7 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	7.1% 2/28 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.	0.00% 0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase. All Treated Population included all participants who received at least one dose of study treatment.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: GSKClinicalSupportHD@gsk.com

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER