Trial Outcomes & Findings for Brentuximab Vedotin in Chinese Participants With Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL) or Systemic Anaplastic Large Cell Lymphoma (sALCL) (NCT NCT02939014)

Last Updated: 2021-02-24

Results Overview

ORR is defined as the percentage of participants who have achieved complete remission (CR)=disappearance of all evidence of disease or partial remission (PR)=regression of greater than or equal to 50% of measurable disease and no new site by end of treatment (EOT) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

39 participants

Primary outcome timeframe

Baseline, at Cycles (each cycle was of 3 weeks) 2, 4, 7, 10, 13, and 16 during treatment until disease progression death or end of treatment (approximately 12 months)

Results posted on

2021-02-24

Participant Flow

Participants took part in the study at 7 investigative sites in China. The study was conducted from 07 November 2016 to 3 February 2020.

Participants with a diagnosis of Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL) or Systemic Anaplastic Large Cell Lymphoma (sALCL) were enrolled to receive brentuximab vedotin 1.8 mg/kg, intravenous (IV) infusion, Day 1 of every 3-week cycle.

Participant milestones

Participant milestones
Measure	Brentuximab Vedotin 1.8 mg/kg (HL) Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL).	Brentuximab Vedotin 1.8 mg/kg (sALCL) Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL).
Overall Study STARTED	30	9
Overall Study COMPLETED	25	6
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Brentuximab Vedotin 1.8 mg/kg (HL) Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL).	Brentuximab Vedotin 1.8 mg/kg (sALCL) Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL).
Overall Study Lost to Follow-up	1	0
Overall Study Death	4	3

Baseline Characteristics

Brentuximab Vedotin in Chinese Participants With Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL) or Systemic Anaplastic Large Cell Lymphoma (sALCL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Brentuximab Vedotin 1.8 mg/kg (HL) n=30 Participants Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL).	Brentuximab Vedotin 1.8 mg/kg (sALCL) n=9 Participants Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL).	Total n=39 Participants Total of all reporting groups
Age, Continuous	31.9 years STANDARD_DEVIATION 8.91 • n=5 Participants	41.1 years STANDARD_DEVIATION 15.28 • n=7 Participants	34.0 years STANDARD_DEVIATION 11.19 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	2 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	7 Participants n=7 Participants	24 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Not Hispanic or Latino	30 Participants n=5 Participants	9 Participants n=7 Participants	39 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	30 Participants n=5 Participants	9 Participants n=7 Participants	39 Participants n=5 Participants
Region of Enrollment China	30 Participants n=5 Participants	9 Participants n=7 Participants	39 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, at Cycles (each cycle was of 3 weeks) 2, 4, 7, 10, 13, and 16 during treatment until disease progression death or end of treatment (approximately 12 months)

Population: Modified Intent-to-Treat (mITT) Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin 1.8 mg/kg (HL) n=30 Participants Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL).	Brentuximab Vedotin 1.8 mg/kg (sALCL) n=9 Participants Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL).
Overall Response Rate (ORR)	70.0 percentage of participants Interval 50.6 to 85.27	66.7 percentage of participants Interval 29.93 to 92.51

PRIMARY outcome

Timeframe: First dose of study drug up to 30 days after last dose of study drug (approximately 12 months)

Population: Safety Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin.

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs or worsens after receiving study drug.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin 1.8 mg/kg (HL) n=30 Participants Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL).	Brentuximab Vedotin 1.8 mg/kg (sALCL) n=9 Participants Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL).
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	30 Participants	9 Participants

PRIMARY outcome

Timeframe: First dose of study drug up to 30 days after last dose of study drug (approximately 12 months)

Population: Safety Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin.

Clinical Laboratory tests included tests of Chemistry, Hematology and Urinalysis prespecified in the protocol. Abnormal laboratory values assessed by the investigator that lead to discontinuation or delay in treatment, dose modification, therapeutic intervention, or were considered by the investigator to be clinically significant changes from Baseline were recorded as Adverse Events. Neutropenia (pooled) includes preferred terms Neutropenia and Neutrophil count decreased.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin 1.8 mg/kg (HL) n=30 Participants Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL).	Brentuximab Vedotin 1.8 mg/kg (sALCL) n=9 Participants Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL).
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Neutropenia (Pooled)	19 Participants	5 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Blood alkaline phosphatase increased	0 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Blood magnesium decreased	0 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Monocytosis	0 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Thrombocytopenia	1 Participants	0 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Hyponatraemia	1 Participants	0 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Lipoprotein (a) increased	0 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Low density lipoprotein increased	0 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Red blood cell sedimentation rate increased	1 Participants	0 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Alanine aminotransferase increased	18 Participants	6 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Aspartate aminotransferase increased	17 Participants	6 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Gamma-glutamyltransferase increased	3 Participants	4 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Blood bilirubin increased	0 Participants	2 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Reticulocyte count decreased	9 Participants	2 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Reticulocyte count increased	6 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Haemoglobin decreased	1 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Reticulocyte percentage increased	1 Participants	0 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events White blood cell count decreased	4 Participants	3 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Lymphocyte count decreased	5 Participants	0 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Lymphocyte percentage decreased	2 Participants	0 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Lymphocyte count increased	0 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Lymphocyte percentage increased	0 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Monocyte count increased	0 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Neutrophil count increased	0 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Neutrophil percentage decreased	1 Participants	0 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events White blood cell count increased	0 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Platelet count decreased	2 Participants	2 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Blood uric acid increased	2 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Blood glucose increased	1 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Blood albumin decreased	0 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Protein total decreased	0 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Blood creatinine increased	1 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Blood urea decreased	0 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Blood urea increased	0 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Blood lactate dehydrogenase increased	0 Participants	2 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Blood cholesterol increased	0 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Blood calcium decreased	0 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Blood calcium increased	0 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Blood chloride decreased	0 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Blood phosphorus decreased	0 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Blood potassium decreased	0 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Blood triglycerides increased	0 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Glucose urine present	1 Participants	0 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Leukopenia	15 Participants	2 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Anaemia	12 Participants	3 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Hyperuricaemia	4 Participants	2 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Hypertriglyceridaemia	2 Participants	2 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Hypokalaemia	3 Participants	2 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Blood creatine phosphokinase increased	1 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Total bile acids increased	0 Participants	2 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Alpha hydroxybutyrate dehydrogenase increased	0 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events High density lipoprotein decreased	0 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Hypercalcaemia	0 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Hyperglycaemia	1 Participants	0 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Hypoalbuminaemia	0 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events Hypocalcaemia	0 Participants	1 Participants

PRIMARY outcome

Timeframe: First dose of study drug up to 30 days after last dose of study drug (approximately 12 months)

Population: Safety Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin.

Vital signs included blood pressure in the sitting position, pulse rate, axillary temperature and weight. Abnormal vital sign values considered by the investigator to be clinically significant were recorded as Adverse Events.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin 1.8 mg/kg (HL) n=30 Participants Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL).	Brentuximab Vedotin 1.8 mg/kg (sALCL) n=9 Participants Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL).
Number of Participants With Abnormal Vital Signs Reported as Adverse Events Weight increased	4 Participants	2 Participants
Number of Participants With Abnormal Vital Signs Reported as Adverse Events Weight decreased	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, at Cycles (each cycle was of 3 weeks) 2, 4, 7, 10, 13, and 16 during treatment, and every 12 weeks during PFS follow-up period, until disease progression death or end of treatment (approximately 12 months)

Population: mITT Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin.

CR rate is defined as the percentage of participants who have achieved CR by EOT. CR is defined as disappearance of all evidence of disease per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin 1.8 mg/kg (HL) n=30 Participants Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL).	Brentuximab Vedotin 1.8 mg/kg (sALCL) n=9 Participants Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL).
Complete Remission (CR) Rate	20.0 percentage of participants Interval 7.71 to 38.57	55.6 percentage of participants Interval 21.2 to 86.3

SECONDARY outcome

Timeframe: Up to 3.2 years

Population: mITT Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin. Only responders were analyzed for this outcome measure.

DOR is defined as the time between the first documentation of objective tumor response (CR or PR) and the first subsequent documentation of objective tumor progression or death due to any cause, whichever occurs first. CR is defined as disappearance of all evidence of disease. PR is defined as regression of greater than or equal to 50% of measurable disease and no new sites.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin 1.8 mg/kg (HL) n=21 Participants Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL).	Brentuximab Vedotin 1.8 mg/kg (sALCL) n=6 Participants Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL).
Duration of Response (DOR)	12.0 months Interval 4.37 to Data for upper limit of CI were not available as all participants were censored.	NA months Interval 1.41 to Data for upper limit of CI were not available as all participants were censored.

SECONDARY outcome

Timeframe: Up to 3.2 years

Population: mITT Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin.

PFS is defined as the time from the start of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin 1.8 mg/kg (HL) n=30 Participants Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL).	Brentuximab Vedotin 1.8 mg/kg (sALCL) n=9 Participants Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL).
Progression Free Survival (PFS)	13.5 months Interval 6.77 to 17.81	23.2 months Interval 1.25 to Data for upper limit of CI was not available as all participants were censored.

SECONDARY outcome

Timeframe: Up to 3.2 years

Population: mITT Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin.

Overall survival is defined as the time from the start of treatment to the date of death.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin 1.8 mg/kg (HL) n=30 Participants Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL).	Brentuximab Vedotin 1.8 mg/kg (sALCL) n=9 Participants Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL).
Overall Survival (OS)	NA months Data for Median and lower and Upper limit of CI was not available due to low number of participants with events.	NA months Interval 3.19 to Data for Median and lower and Upper limit of CI was not available due to low number of participants with events.

SECONDARY outcome

Timeframe: Day 1 of each cycle (each cycle was of 3 weeks) up to 30 days after last dose of study drug (approximately 12 months)

Population: Participants from the mITT Population, all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin, who had lymphoma-related B symptoms at baseline.

B Symptom Resolution Rate is defined as the percentage of participants with lymphoma-related symptoms (B symptoms: fever, night sweats, or weight loss \>10%) at baseline who achieved resolution of all B symptoms at any time during the treatment period.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin 1.8 mg/kg (HL) n=2 Participants Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL).	Brentuximab Vedotin 1.8 mg/kg (sALCL) n=2 Participants Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL).
B Symptom Resolution Rate	50.0 percentage of participants Interval 1.26 to 98.74	100.00 percentage of participants Interval 15.81 to 100.0

SECONDARY outcome

Timeframe: Cycles (each cycle was of 3 weeks) 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose

Population: Pharmacokinetic (PK)-evaluable Population includes participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by the clinical pharmacologist.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin 1.8 mg/kg (HL) n=39 Participants Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL).	Brentuximab Vedotin 1.8 mg/kg (sALCL) Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL).
Cmax: Maximum Observed Serum Concentration for Brentuximab Vedotin Antibody-drug Conjugate (ADC) Cycle 1	36.9504 micrograms/milliliter (ug/mL) Standard Deviation 9.90360	—
Cmax: Maximum Observed Serum Concentration for Brentuximab Vedotin Antibody-drug Conjugate (ADC) Cycle 2	32.4341 micrograms/milliliter (ug/mL) Standard Deviation 5.83197	—

SECONDARY outcome

Timeframe: Cycles (each cycle was of 3 weeks) 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose

Population: PK-evaluable Population includes participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by the clinical pharmacologist.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin 1.8 mg/kg (HL) n=39 Participants Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL).	Brentuximab Vedotin 1.8 mg/kg (sALCL) Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL).
Cmax: Maximum Observed Serum Concentration for Total Antibody (TAb) Cycle 1	38.2293 ug/mL Standard Deviation 7.95483	—
Cmax: Maximum Observed Serum Concentration for Total Antibody (TAb) Cycle 2	39.9859 ug/mL Standard Deviation 12.43445	—

SECONDARY outcome

Timeframe: Cycles (each cycle was of 3 weeks) 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose

Population: PK-evaluable Population includes participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by the clinical pharmacologist.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin 1.8 mg/kg (HL) n=39 Participants Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL).	Brentuximab Vedotin 1.8 mg/kg (sALCL) Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL).
Cmax: Maximum Observed Plasma Concentration for Monomethyl Auristatin E (MMAE) Cycle 1	5.1623 ug/mL Standard Deviation 3.69893	—
Cmax: Maximum Observed Plasma Concentration for Monomethyl Auristatin E (MMAE) Cycle 2	3.6218 ug/mL Standard Deviation 2.89331	—

SECONDARY outcome

Timeframe: Cycles (each cycle was of 3 weeks) 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose

Population: PK-evaluable Population includes participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by the clinical pharmacologist.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin 1.8 mg/kg (HL) n=39 Participants Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL).	Brentuximab Vedotin 1.8 mg/kg (sALCL) Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL).
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Brentuximab Vedotin ADC Cycle 1	0.0576 days Interval 0.031 to 0.221	—
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Brentuximab Vedotin ADC Cycle 2	0.0528 days Interval 0.028 to 0.214	—

SECONDARY outcome

Timeframe: Cycles (each cycle was of 3 weeks) 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose

Population: PK-evaluable Population includes participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by the clinical pharmacologist.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin 1.8 mg/kg (HL) n=39 Participants Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL).	Brentuximab Vedotin 1.8 mg/kg (sALCL) Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL).
Tmax: Time to Reach the Maximum Serum Concentration (Cmax) for TAb Cycle 1	0.0653 days Interval 0.031 to 1.067	—
Tmax: Time to Reach the Maximum Serum Concentration (Cmax) for TAb Cycle 2	0.0660 days Interval 0.028 to 0.972	—

SECONDARY outcome

Timeframe: Cycles (each cycle was of 3 weeks) 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose

Population: PK-evaluable Population includes participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by the clinical pharmacologist.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin 1.8 mg/kg (HL) n=39 Participants Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL).	Brentuximab Vedotin 1.8 mg/kg (sALCL) Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL).
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MMAE Cycle 1	2.0729 days Interval 1.031 to 6.991	—
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MMAE Cycle 2	2.9785 days Interval 0.178 to 6.986	—

SECONDARY outcome

Timeframe: Cycle (each cycle was of 3 weeks) 1: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose

Population: Participants from the PK-evaluable Populations, participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by the clinical pharmacologist, with data available for analysis.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin 1.8 mg/kg (HL) n=38 Participants Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL).	Brentuximab Vedotin 1.8 mg/kg (sALCL) Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL).
AUC(0-∞): Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Brentuximab Vedotin ADC	79.9951 day*ug/mL Standard Deviation 19.59116	—

SECONDARY outcome

Timeframe: Cycle (each cycle was of 3 weeks) 1: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose

Population: PK-evaluable Population includes participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by the clinical pharmacologist.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin 1.8 mg/kg (HL) n=39 Participants Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL).	Brentuximab Vedotin 1.8 mg/kg (sALCL) Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL).
AUC(0-∞): Area Under the Serum Concentration-time Curve From Time 0 to Infinity for TAb	168.6618 day*ug/mL Standard Deviation 41.62840	—

SECONDARY outcome

Timeframe: Cycle (each cycle was of 3 weeks) 1: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose

Population: PK-evaluable Population includes participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by the clinical pharmacologist.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin 1.8 mg/kg (HL) n=39 Participants Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL).	Brentuximab Vedotin 1.8 mg/kg (sALCL) Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL).
AUC(0-∞): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for MMAE	36.8625 day*ug/mL Standard Deviation 22.79816	—

SECONDARY outcome

Timeframe: Baseline, at Cycles (each cycle was of 3 weeks) 2, 4, 7, 10, 13, and 16 during treatment until disease progression, death or end of treatment (approximately 12 months)

Population: Immunogenicity Population included participants who received at least 1 dose of brentuximab vedotin and had ATA status assessment at baseline, and at least 1 postbaseline sample. Number analyzed is the number of participants with data available.

Blood samples were collected to assess the immunogenicity of brentuximab vedotin (ATA development) using a laboratory test to determine ATA titers. Confirmed ATA-positive response was categorized as transient (defined as 1 or 2 post-baseline confirmed ATA-positive responses) and persistent (defined as more than 2 post-baseline confirmed ATA positive responses) and by nATA status. The number of participants in each baseline ATA and post-baseline ATA categories are reported.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin 1.8 mg/kg (HL) n=30 Participants Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL).	Brentuximab Vedotin 1.8 mg/kg (sALCL) n=9 Participants Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL).
Number of Participants With Antitherapeutic Antibodies (ATA) and Neutralizing Antitherapeutic Antibodies (nATA) to Brentuximab Vedotin Baseline ATA Positive, nATA Positive	1 Participants	—
Number of Participants With Antitherapeutic Antibodies (ATA) and Neutralizing Antitherapeutic Antibodies (nATA) to Brentuximab Vedotin Baseline ATA Negative	29 Participants	9 Participants
Number of Participants With Antitherapeutic Antibodies (ATA) and Neutralizing Antitherapeutic Antibodies (nATA) to Brentuximab Vedotin Baseline ATA Negative, ATA Negative	21 Participants	8 Participants
Number of Participants With Antitherapeutic Antibodies (ATA) and Neutralizing Antitherapeutic Antibodies (nATA) to Brentuximab Vedotin Baseline ATA Negative, Transiently ATA Positive	7 Participants	1 Participants
Number of Participants With Antitherapeutic Antibodies (ATA) and Neutralizing Antitherapeutic Antibodies (nATA) to Brentuximab Vedotin Baseline ATA Negative, Persistently ATA Positive	1 Participants	0 Participants
Number of Participants With Antitherapeutic Antibodies (ATA) and Neutralizing Antitherapeutic Antibodies (nATA) to Brentuximab Vedotin Baseline ATA Negative, nATA Negative	0 Participants	0 Participants
Number of Participants With Antitherapeutic Antibodies (ATA) and Neutralizing Antitherapeutic Antibodies (nATA) to Brentuximab Vedotin Baseline ATA Negative, nATA Positive	8 Participants	1 Participants
Number of Participants With Antitherapeutic Antibodies (ATA) and Neutralizing Antitherapeutic Antibodies (nATA) to Brentuximab Vedotin Baseline ATA Positive	1 Participants	0 Participants
Number of Participants With Antitherapeutic Antibodies (ATA) and Neutralizing Antitherapeutic Antibodies (nATA) to Brentuximab Vedotin Baseline ATA Positive, ATA Negative	0 Participants	—
Number of Participants With Antitherapeutic Antibodies (ATA) and Neutralizing Antitherapeutic Antibodies (nATA) to Brentuximab Vedotin Baseline ATA Positive, Transiently ATA Positive	0 Participants	—
Number of Participants With Antitherapeutic Antibodies (ATA) and Neutralizing Antitherapeutic Antibodies (nATA) to Brentuximab Vedotin Baseline ATA Positive, Persistently ATA Positive	1 Participants	—
Number of Participants With Antitherapeutic Antibodies (ATA) and Neutralizing Antitherapeutic Antibodies (nATA) to Brentuximab Vedotin Baseline ATA Positive, nATA Negative	0 Participants	—

Adverse Events

Brentuximab Vedotin 1.8 mg/kg (HL)

Serious events: 1 serious events

Other events: 30 other events

Deaths: 4 deaths

Brentuximab Vedotin 1.8 mg/kg (sALCL)

Serious events: 1 serious events

Other events: 9 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Brentuximab Vedotin 1.8 mg/kg (HL) n=30 participants at risk Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL).	Brentuximab Vedotin 1.8 mg/kg (sALCL) n=9 participants at risk Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL).
Gastrointestinal disorders Large intestine polyp	0.00% 0/30 • All-Cause Mortality: up to 3.2 years; Serious and Other Adverse Events: First dose of study drug up to 30 days post last dose of study drug (up to 12 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 1/9 • All-Cause Mortality: up to 3.2 years; Serious and Other Adverse Events: First dose of study drug up to 30 days post last dose of study drug (up to 12 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Lung infection	3.3% 1/30 • All-Cause Mortality: up to 3.2 years; Serious and Other Adverse Events: First dose of study drug up to 30 days post last dose of study drug (up to 12 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/9 • All-Cause Mortality: up to 3.2 years; Serious and Other Adverse Events: First dose of study drug up to 30 days post last dose of study drug (up to 12 months) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Other adverse events

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor's confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application
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