Trial Outcomes & Findings for Study to Separately Evaluate the Activity of Talacotuzumab (JNJ-56022473) or Daratumumab in Transfusion-Dependent Participants With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) Who Are Relapsed or Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment (NCT NCT03011034)

Last Updated: 2025-03-04

Results Overview

Percentage of participants who achieved RBC TI lasting at least 8 weeks were reported. RBC TI was defined as absence of RBC transfusion during any consecutive 56 days (8 weeks) post randomization.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

34 participants

Primary outcome timeframe

Up to 2 years

Results posted on

2025-03-04

Participant Flow

Out of 34 enrolled participants, 33 participants received daratumumab and 1 participant received talacotuzumab.

Due to serious infusion-related reaction (IRR) event that occurred in first participant enrolled in talacotuzumab arm, no further participants were enrolled in this arm.

Participant milestones

Participant milestones
Measure	Talacotuzumab Participant received a single dose of talacotuzumab 9 milligram per kilogram (mg/kg) intravenously (IV).	Daratumumab Participants received daratumumab 16 mg/kg IV weekly on Weeks 1 to 8 (on Days 1, 8, 15, and 22 for Cycles 1 and 2), every 2 weeks for Weeks 9 to 24 (on Days 1 and 15 for Cycles 3 to 6), and every 4 weeks thereafter (on Day 1 for all subsequent cycles). Each treatment cycle was 28 days.
Overall Study STARTED	1	33
Overall Study COMPLETED	0	33
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Talacotuzumab Participant received a single dose of talacotuzumab 9 milligram per kilogram (mg/kg) intravenously (IV).	Daratumumab Participants received daratumumab 16 mg/kg IV weekly on Weeks 1 to 8 (on Days 1, 8, 15, and 22 for Cycles 1 and 2), every 2 weeks for Weeks 9 to 24 (on Days 1 and 15 for Cycles 3 to 6), and every 4 weeks thereafter (on Day 1 for all subsequent cycles). Each treatment cycle was 28 days.
Overall Study Adverse Event	1	0

Baseline Characteristics

Study to Separately Evaluate the Activity of Talacotuzumab (JNJ-56022473) or Daratumumab in Transfusion-Dependent Participants With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) Who Are Relapsed or Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Talacotuzumab n=1 Participants Participant received a single dose of talacotuzumab 9 milligram per kilogram (mg/kg) intravenously (IV).	Daratumumab n=33 Participants Participants received daratumumab 16 mg/kg IV weekly on Weeks 1 to 8 (on Days 1, 8, 15, and 22 for Cycles 1 and 2), every 2 weeks for Weeks 9 to 24 (on Days 1 and 15 for Cycles 3 to 6), and every 4 weeks thereafter (on Day 1 for all subsequent cycles). Each treatment cycle was 28 days.	Total n=34 Participants Total of all reporting groups
Age, Continuous	67 years n=5 Participants	71.5 years STANDARD_DEVIATION 6.86 • n=7 Participants	71.4 years STANDARD_DEVIATION 6.8 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	25 Participants n=7 Participants	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	27 Participants n=7 Participants	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or Not Reported	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized White	1 Participants n=5 Participants	29 Participants n=7 Participants	30 Participants n=5 Participants
Region of Enrollment BELGIUM	1 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment ITALY	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment NETHERLANDS	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment RUSSIAN FEDERATION	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment SPAIN	0 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment UNITED STATES	0 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 2 years

Population: Intent-to-treat (ITT) population included all participants who received at least 1 dose of study drug.

Percentage of participants who achieved RBC TI lasting at least 8 weeks were reported. RBC TI was defined as absence of RBC transfusion during any consecutive 56 days (8 weeks) post randomization.

Outcome measures

Outcome measures
Measure	Talacotuzumab n=1 Participants Participant received a single dose of talacotuzumab 9 milligram per kilogram (mg/kg) intravenously (IV).	Daratumumab n=33 Participants Participants received daratumumab 16 mg/kg IV weekly on Weeks 1 to 8 (on Days 1, 8, 15, and 22 for Cycles 1 and 2), every 2 weeks for Weeks 9 to 24 (on Days 1 and 15 for Cycles 3 to 6), and every 4 weeks thereafter (on Day 1 for all subsequent cycles). Each treatment cycle was 28 days.
Percentage of Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence (TI) Lasting at Least 8 Weeks	0 Percentage of participants	6.1 Percentage of participants Interval 0.7 to 20.2

SECONDARY outcome

Timeframe: Up to 2 years

Population: ITT population included all participants who received at least 1 dose of study drug.

Percentage of participants who achieved RBC TI lasting at least 24 weeks were reported. RBC TI was defined as absence of RBC transfusion during any consecutive 56 days (8 weeks) post randomization.

Outcome measures

Outcome measures
Measure	Talacotuzumab n=1 Participants Participant received a single dose of talacotuzumab 9 milligram per kilogram (mg/kg) intravenously (IV).	Daratumumab n=33 Participants Participants received daratumumab 16 mg/kg IV weekly on Weeks 1 to 8 (on Days 1, 8, 15, and 22 for Cycles 1 and 2), every 2 weeks for Weeks 9 to 24 (on Days 1 and 15 for Cycles 3 to 6), and every 4 weeks thereafter (on Day 1 for all subsequent cycles). Each treatment cycle was 28 days.
Percentage of Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence (TI) Lasting at Least 24 Weeks	0 Percentage of participants	3.0 Percentage of participants Interval 0.1 to 15.8

SECONDARY outcome

Timeframe: Up to 2 years

Population: ITT population who achieved TI for at least 8 weeks. As less number of participants were evaluable for this outcome measure (OM), the results were not summarized. Hence, participant wise data is reported.

Time to transfusion independence (TI) was defined as time to the start of the TI interval. TI was defined as absence of RBC transfusion during any consecutive 56 days (8 weeks) post randomization.

Outcome measures

Outcome measures
Measure	Talacotuzumab n=1 Participants Participant received a single dose of talacotuzumab 9 milligram per kilogram (mg/kg) intravenously (IV).	Daratumumab n=2 Participants Participants received daratumumab 16 mg/kg IV weekly on Weeks 1 to 8 (on Days 1, 8, 15, and 22 for Cycles 1 and 2), every 2 weeks for Weeks 9 to 24 (on Days 1 and 15 for Cycles 3 to 6), and every 4 weeks thereafter (on Day 1 for all subsequent cycles). Each treatment cycle was 28 days.
Time to Transfusion Independence (TI) Participant 1	—	4 Weeks
Time to Transfusion Independence (TI) Participant 2	—	5 Weeks
Time to Transfusion Independence (TI) Participant 3	NA Weeks Here, NA signifies that time to TI could not be estimated as this participant did not achieve TI.	—

SECONDARY outcome

Timeframe: Up to 2 years

Duration of TI was reported. TI was defined as absence of RBC transfusion during any consecutive 56 days (8 weeks) post randomization.

Outcome measures

Outcome measures
Measure	Talacotuzumab n=1 Participants Participant received a single dose of talacotuzumab 9 milligram per kilogram (mg/kg) intravenously (IV).	Daratumumab n=2 Participants Participants received daratumumab 16 mg/kg IV weekly on Weeks 1 to 8 (on Days 1, 8, 15, and 22 for Cycles 1 and 2), every 2 weeks for Weeks 9 to 24 (on Days 1 and 15 for Cycles 3 to 6), and every 4 weeks thereafter (on Day 1 for all subsequent cycles). Each treatment cycle was 28 days.
Duration of Transfusion Independence (TI) Participant 1	—	16 Weeks
Duration of Transfusion Independence (TI) Participant 2	—	65 Weeks
Duration of Transfusion Independence (TI) Participant 3	NA Weeks Here, NA signifies that duration of TI could not be estimated as this participant did not achieve TI.	—

SECONDARY outcome

Timeframe: Up to 2 years

Population: ITT population included all participants who received at least 1 dose of study drug.

Percentage of participants who met IWG criteria for transfusion reduction were reported. IWG criteria for transfusion reduction: at least 4 units reduction in RBC transfusions in the best 8-week interval. The best 8-week interval was a post-baseline 8-week interval where the participant had the fewest post-baseline RBC transfusion units.

Outcome measures

Outcome measures
Measure	Talacotuzumab n=1 Participants Participant received a single dose of talacotuzumab 9 milligram per kilogram (mg/kg) intravenously (IV).	Daratumumab n=33 Participants Participants received daratumumab 16 mg/kg IV weekly on Weeks 1 to 8 (on Days 1, 8, 15, and 22 for Cycles 1 and 2), every 2 weeks for Weeks 9 to 24 (on Days 1 and 15 for Cycles 3 to 6), and every 4 weeks thereafter (on Day 1 for all subsequent cycles). Each treatment cycle was 28 days.
Percentage of Participants Who Met IWG Criteria for Transfusion Reduction	0 Percentage of participants	54.5 Percentage of participants

SECONDARY outcome

Timeframe: Up to 2 years

Population: ITT population included all participants who received at least 1 dose of study drug.

Percentage of participants with Myeloid Growth Factors (MGF) usage (who had used at least 1 dose of MGF) were reported.

Outcome measures

Outcome measures
Measure	Talacotuzumab n=1 Participants Participant received a single dose of talacotuzumab 9 milligram per kilogram (mg/kg) intravenously (IV).	Daratumumab n=33 Participants Participants received daratumumab 16 mg/kg IV weekly on Weeks 1 to 8 (on Days 1, 8, 15, and 22 for Cycles 1 and 2), every 2 weeks for Weeks 9 to 24 (on Days 1 and 15 for Cycles 3 to 6), and every 4 weeks thereafter (on Day 1 for all subsequent cycles). Each treatment cycle was 28 days.
Percentage of Participants With at Least One Dose of Myeloid Growth Factors Usage	0 Percentage of participants	9.1 Percentage of participants

SECONDARY outcome

Timeframe: Up to 2 years

Population: ITT population included all participants who received at least 1 dose of study drug.

Percentage of participants with HI per International Working Group (IWG) 2006 by investigator assessment were reported. Response criteria per IWG 2006 for HI: Erythroid response (pretreatment, less than \[\<\]11 gram per deciliter \[g/dL\]) - hemoglobin increase by greater than or equal to (\>=)1.5 g/dL, relevant reduction of units of RBC transfusions by an absolute number of at least 4 RBC transfusions/8 weeks compared with the pretreatment transfusion number in the previous 8 weeks. Only RBC transfusions given for a Hb of \<=9 g/dL pretreatment counted in the RBC transfusion response evaluation; Platelet response (pretreatment, \<100\*10\^9/L) - absolute increase of \>=30\*10\^9/L for participants starting with \>20\*10\^9/L platelets. Increase from \<20\*10\^9/L to \>20\*10\^9/L and by at least 100 percent (%); Neutrophil response (pretreatment, \<1\*10\^9/L) - at least 100% increase and an absolute increase \>0.5\*10\^9/L.

Outcome measures

Outcome measures
Measure	Talacotuzumab n=1 Participants Participant received a single dose of talacotuzumab 9 milligram per kilogram (mg/kg) intravenously (IV).	Daratumumab n=33 Participants Participants received daratumumab 16 mg/kg IV weekly on Weeks 1 to 8 (on Days 1, 8, 15, and 22 for Cycles 1 and 2), every 2 weeks for Weeks 9 to 24 (on Days 1 and 15 for Cycles 3 to 6), and every 4 weeks thereafter (on Day 1 for all subsequent cycles). Each treatment cycle was 28 days.
Percentage of Participants With Hematologic Improvement (HI) Per IWG 2006 by Investigator Assessment Erythroid Response	0 Percentage of participants	9.1 Percentage of participants Interval 1.9 to 24.3
Percentage of Participants With Hematologic Improvement (HI) Per IWG 2006 by Investigator Assessment Platelet Response	0 Percentage of participants	0.0 Percentage of participants Interval 0.0 to 10.6
Percentage of Participants With Hematologic Improvement (HI) Per IWG 2006 by Investigator Assessment Neutrophil Response	0 Percentage of participants	0.0 Percentage of participants Interval 0.0 to 10.6

SECONDARY outcome

Timeframe: Up to 2 years

Population: ITT population included all participants who received at least 1 dose of study drug.

Percentage of participants with CR and marrow CR were reported. CR per International Working Group (IWG) 2006 Response criteria: Bone marrow - less than or equal to (\<=)5% myeloblasts with normal maturation of all cell lines, persistent dysplasia noted; Peripheral blood - hemoglobin \>=11 g/dL; platelets \>=100\*10\^9/L; neutrophils \>=1.0\*10\^9/L; blasts, 0%. Marrow CR: Bone marrow - \<=5% myeloblasts and decrease by \>=50% over pretreatment; Peripheral blood - if HI responses, they were noted in addition to marrow CR.

Outcome measures

Outcome measures
Measure	Talacotuzumab n=1 Participants Participant received a single dose of talacotuzumab 9 milligram per kilogram (mg/kg) intravenously (IV).	Daratumumab n=33 Participants Participants received daratumumab 16 mg/kg IV weekly on Weeks 1 to 8 (on Days 1, 8, 15, and 22 for Cycles 1 and 2), every 2 weeks for Weeks 9 to 24 (on Days 1 and 15 for Cycles 3 to 6), and every 4 weeks thereafter (on Day 1 for all subsequent cycles). Each treatment cycle was 28 days.
Percentage of Participants With Complete Remission (CR) and Marrow CR Complete Remission (CR)	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Complete Remission (CR) and Marrow CR Marrow CR	0 Percentage of participants	3.0 Percentage of participants

SECONDARY outcome

Timeframe: Up to 2 years

Population: ITT population included all participants who received at least 1 dose of study drug.

Percentage of participants with PR were reported. PR per International Working Group (IWG) 2006 Response criteria: All CR criteria if abnormal before treatment except: Bone marrow blasts decreased by \>=50% over pretreatment but still \>5%, cellularity and morphology not relevant.

Outcome measures

Outcome measures
Measure	Talacotuzumab n=1 Participants Participant received a single dose of talacotuzumab 9 milligram per kilogram (mg/kg) intravenously (IV).	Daratumumab n=33 Participants Participants received daratumumab 16 mg/kg IV weekly on Weeks 1 to 8 (on Days 1, 8, 15, and 22 for Cycles 1 and 2), every 2 weeks for Weeks 9 to 24 (on Days 1 and 15 for Cycles 3 to 6), and every 4 weeks thereafter (on Day 1 for all subsequent cycles). Each treatment cycle was 28 days.
Percentage of Participants With Partial Remission (PR)	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Up to 2 years

Population: ITT population included all participants who received at least 1 dose of study drug.

Percentage of participants with cytogenetic response were reported. Cytogenetic response per International Working Group (IWG) 2006 Response criteria: Complete - disappearance of the chromosomal abnormality without appearance of new ones; Partial - at least 50% reduction of the chromosomal abnormality.

Outcome measures

Outcome measures
Measure	Talacotuzumab n=1 Participants Participant received a single dose of talacotuzumab 9 milligram per kilogram (mg/kg) intravenously (IV).	Daratumumab n=33 Participants Participants received daratumumab 16 mg/kg IV weekly on Weeks 1 to 8 (on Days 1, 8, 15, and 22 for Cycles 1 and 2), every 2 weeks for Weeks 9 to 24 (on Days 1 and 15 for Cycles 3 to 6), and every 4 weeks thereafter (on Day 1 for all subsequent cycles). Each treatment cycle was 28 days.
Percentage of Participants With Cytogenetic Response	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Up to 2 years

Population: ITT population included all participants who received at least 1 dose of study drug.

The overall survival was defined as the time from the date of first dose of study drug to date of death from any cause. Median overall survival was estimated by using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Talacotuzumab n=1 Participants Participant received a single dose of talacotuzumab 9 milligram per kilogram (mg/kg) intravenously (IV).	Daratumumab n=33 Participants Participants received daratumumab 16 mg/kg IV weekly on Weeks 1 to 8 (on Days 1, 8, 15, and 22 for Cycles 1 and 2), every 2 weeks for Weeks 9 to 24 (on Days 1 and 15 for Cycles 3 to 6), and every 4 weeks thereafter (on Day 1 for all subsequent cycles). Each treatment cycle was 28 days.
Overall Survival	NA Months Here, NA signifies that the median, lower and upper limit of Confidence Interval (CI) could not be calculated for single participant.	NA Months Here, NA signifies that the median, lower and upper limit of Confidence Interval (CI) were not estimable due to lesser number of events.

SECONDARY outcome

Timeframe: Up to 2 years

Population: ITT population included all participants who received at least 1 dose of study drug.

Time to progression to acute myeloid leukemia was reported. Disease progression as per IWG response criteria: For participants with: \<5% blasts: \>=50% increase in blasts to \>5% blasts; 5%-10% blasts: \>=50% increase to \>10% blasts; 10%-20% blasts: \>=50% increase to \>20% blasts; 20%-30% blasts: \>=50% increase to \>30% blasts. Any of the following: \>=50% decrement from maximum remission/response in granulocytes or platelets; reduction in hemoglobin by \>=2 g/dL; transfusion dependence.

Outcome measures

Outcome measures
Measure	Talacotuzumab n=1 Participants Participant received a single dose of talacotuzumab 9 milligram per kilogram (mg/kg) intravenously (IV).	Daratumumab n=33 Participants Participants received daratumumab 16 mg/kg IV weekly on Weeks 1 to 8 (on Days 1, 8, 15, and 22 for Cycles 1 and 2), every 2 weeks for Weeks 9 to 24 (on Days 1 and 15 for Cycles 3 to 6), and every 4 weeks thereafter (on Day 1 for all subsequent cycles). Each treatment cycle was 28 days.
Time to Progression to Acute Myeloid Leukemia (AML)	NA Weeks Here, NA signifies that the median, lower and upper limit of Confidence Interval (CI) could not be calculated for single participant.	NA Weeks Interval 54.7 to Here, NA signifies that the median and upper limit of Confidence Interval (CI) were not estimable due to lesser number of events.

Adverse Events

Talacotuzumab

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Daratumumab

Serious events: 15 serious events

Other events: 33 other events

Deaths: 6 deaths

Serious adverse events

Other adverse events

Additional Information

Global Medical Head

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Publication restrictions are in place

Restriction type: OTHER

Measure	Talacotuzumab n=1 participants at risk Participant received a single dose of talacotuzumab 9 milligram per kilogram (mg/kg) intravenously (IV).	Daratumumab n=33 participants at risk Participants received daratumumab 16 mg/kg IV weekly on Weeks 1 to 8 (on Days 1, 8, 15, and 22 for Cycles 1 and 2), every 2 weeks for Weeks 9 to 24 (on Days 1 and 15 for Cycles 3 to 6), and every 4 weeks thereafter (on Day 1 for all subsequent cycles). Each treatment cycle was 28 days.
Cardiac disorders Acute Coronary Syndrome	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	3.0% 1/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Cardiac disorders Atrial Fibrillation	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	3.0% 1/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Cardiac disorders Cardiac Failure	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	3.0% 1/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Cardiac disorders Cardiac Failure Congestive	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	3.0% 1/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Diarrhoea	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	3.0% 1/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Rectal Haemorrhage	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	3.0% 1/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
General disorders Asthenia	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	3.0% 1/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
General disorders Pyrexia	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	9.1% 3/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Immune system disorders Autoimmune Disorder	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	3.0% 1/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Infections and infestations Corona Virus Infection	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	3.0% 1/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Infections and infestations Influenza	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	3.0% 1/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Infections and infestations Lung Infection	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	3.0% 1/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Infections and infestations Lung Infection Pseudomonal	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	3.0% 1/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Infections and infestations Pneumonia	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	9.1% 3/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Infections and infestations Respiratory Tract Infection	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	3.0% 1/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Fall	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	3.0% 1/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Hand Fracture	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	3.0% 1/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Rib Fracture	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	3.0% 1/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	3.0% 1/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Metabolic Acidosis	100.0% 1/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	0.00% 0/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic Cancer	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	3.0% 1/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Nervous system disorders Transient Ischaemic Attack	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	3.0% 1/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	3.0% 1/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	100.0% 1/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	0.00% 0/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Laryngeal Oedema	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	3.0% 1/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Vascular disorders Thrombophlebitis Superficial	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	3.0% 1/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.

Measure	Talacotuzumab n=1 participants at risk Participant received a single dose of talacotuzumab 9 milligram per kilogram (mg/kg) intravenously (IV).	Daratumumab n=33 participants at risk Participants received daratumumab 16 mg/kg IV weekly on Weeks 1 to 8 (on Days 1, 8, 15, and 22 for Cycles 1 and 2), every 2 weeks for Weeks 9 to 24 (on Days 1 and 15 for Cycles 3 to 6), and every 4 weeks thereafter (on Day 1 for all subsequent cycles). Each treatment cycle was 28 days.
Blood and lymphatic system disorders Anaemia	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	18.2% 6/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Neutropenia	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	18.2% 6/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	27.3% 9/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Cardiac disorders Atrial Fibrillation	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	9.1% 3/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Ear and labyrinth disorders Vertigo	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	6.1% 2/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Eye disorders Conjunctival Haemorrhage	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	6.1% 2/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Constipation	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	15.2% 5/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Diarrhoea	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	21.2% 7/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Nausea	100.0% 1/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	9.1% 3/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Vomiting	100.0% 1/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	9.1% 3/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
General disorders Asthenia	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	18.2% 6/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
General disorders Chills	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	6.1% 2/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
General disorders Fatigue	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	18.2% 6/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
General disorders Oedema Peripheral	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	18.2% 6/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
General disorders Peripheral Swelling	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	6.1% 2/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
General disorders Pyrexia	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	24.2% 8/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	6.1% 2/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Infections and infestations Bronchitis	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	9.1% 3/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Infections and infestations Campylobacter Infection	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	6.1% 2/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Infections and infestations Herpes Simplex	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	6.1% 2/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Infections and infestations Pneumonia	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	6.1% 2/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Infections and infestations Urinary Tract Infection	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	12.1% 4/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Fall	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	9.1% 3/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Infusion Related Reaction	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	12.1% 4/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Investigations Blood Creatinine Increased	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	6.1% 2/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Investigations Weight Decreased	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	6.1% 2/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Dehydration	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	9.1% 3/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	9.1% 3/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Type 2 Diabetes Mellitus	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	6.1% 2/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	6.1% 2/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	9.1% 3/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Muscle Spasms	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	6.1% 2/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	6.1% 2/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Nervous system disorders Dizziness	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	6.1% 2/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Nervous system disorders Headache	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	15.2% 5/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Nervous system disorders Paraesthesia	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	6.1% 2/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Renal and urinary disorders Renal Impairment	100.0% 1/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	0.00% 0/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	18.2% 6/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	12.1% 4/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea Exertional	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	6.1% 2/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	9.1% 3/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Night Sweats	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	6.1% 2/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	6.1% 2/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Vascular disorders Hypertension	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	15.2% 5/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Vascular disorders Hypotension	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	6.1% 2/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Vascular disorders Pallor	0.00% 0/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	6.1% 2/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	100.0% 1/1 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.	0.00% 0/33 • Up to 2 years Safety population included all participants who received at least 1 dose of study drug.