Trial Outcomes & Findings for Study of Brentuximab Vedotin (SGN-35) in Pediatric Participants With Relapsed or Refractory (r/r) Systemic Anaplastic Large-Cell Lymphoma or Hodgkin Lymphoma (NCT NCT01492088)

NCT ID: NCT01492088

Last Updated: 2024-05-30

Results Overview

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. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. AE severity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

36 participants

Primary outcome timeframe

From the first dose through 30 days after the last dose of study medication (Up to 15 months)

Results posted on

2024-05-30

Participant Flow

Participants took part in the study at 12 investigative sites in United States, France, Germany, Netherlands, United Kingdom, Italy, Spain and Mexico from 16-April-2012 to 12-April-2018.

Participants with diagnosis of relapsed or refractory (r/r) sALCL/HL were enrolled to receive brentuximab vedotin 1.4-1.8 mg/kg, intravenous infusion on Day 1 of every 21-day cycle for up to 16 cycles. Treatment beyond 16 cycles was permitted at joint discretion of sponsor and investigator for participants experiencing continued clinical benefit.

Participant milestones

Participant milestones
Measure	Brentuximab Vedotin 1.4 mg/kg: Phase 1 Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Overall Study STARTED	3	16	17
Overall Study COMPLETED	0	2	3
Overall Study NOT COMPLETED	3	14	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Brentuximab Vedotin 1.4 mg/kg: Phase 1 Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Overall Study Withdrawal by Patient	0	2	0
Overall Study Death	1	6	2
Overall Study Completed Post Treatment Followup (PTFU)	2	0	1
Overall Study Alive at Last Follow-up	0	6	11

Baseline Characteristics

Study of Brentuximab Vedotin (SGN-35) in Pediatric Participants With Relapsed or Refractory (r/r) Systemic Anaplastic Large-Cell Lymphoma or Hodgkin Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Brentuximab Vedotin 1.4 mg/kg: Phase 1 n=3 Participants Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only n=16 Participants Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only n=17 Participants Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.	Total n=36 Participants Total of all reporting groups
Age, Continuous	14.7 years STANDARD_DEVIATION 1.15 • n=5 Participants	14.5 years STANDARD_DEVIATION 2.68 • n=7 Participants	11.5 years STANDARD_DEVIATION 3.18 • n=5 Participants	13.1 years STANDARD_DEVIATION 3.19 • n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	11 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants	25 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	14 Participants n=7 Participants	12 Participants n=5 Participants	29 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized White	2 Participants n=5 Participants	13 Participants n=7 Participants	16 Participants n=5 Participants	31 Participants n=4 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Region of Enrollment France	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment Germany	0 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Region of Enrollment Netherlands	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Region of Enrollment United Kingdom	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Region of Enrollment Italy	1 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	14 Participants n=4 Participants
Region of Enrollment Spain	0 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants
Region of Enrollment Mexico	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Height	167.17 cm STANDARD_DEVIATION 10.865 • n=5 Participants	165.31 cm STANDARD_DEVIATION 14.350 • n=7 Participants	149.54 cm STANDARD_DEVIATION 17.783 • n=5 Participants	158.02 cm STANDARD_DEVIATION 17.493 • n=4 Participants
Weight	53.10 kg STANDARD_DEVIATION 9.924 • n=5 Participants	57.85 kg STANDARD_DEVIATION 17.539 • n=7 Participants	42.16 kg STANDARD_DEVIATION 15.162 • n=5 Participants	50.04 kg STANDARD_DEVIATION 17.361 • n=4 Participants
Body Surface Area	1.562 m^2 STANDARD_DEVIATION 0.0967 • n=5 Participants	1.617 m^2 STANDARD_DEVIATION 0.2938 • n=7 Participants	1.313 m^2 STANDARD_DEVIATION 0.3103 • n=5 Participants	1.469 m^2 STANDARD_DEVIATION 0.3228 • n=4 Participants

PRIMARY outcome

Timeframe: From the first dose through 30 days after the last dose of study medication (Up to 15 months)

Population: Safety population is defined as all participants who received at least 1 dose of study drug. Participants enrolled in Phase 1 of study were evaluated for this outcome measure.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin 1.4 mg/kg: Phase 1 n=3 Participants Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 n=9 Participants Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Phase 1) TEAE	3 Participants	9 Participants	—
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Phase 1) SAE	0 Participants	4 Participants	—

PRIMARY outcome

Timeframe: From the first dose through 30 days after the last dose of study medication (Up to 15 months)

Population: Safety population is defined as all participants who received at least 1 dose of study drug. Participants enrolled in Phase 1 of study were evaluated for this outcome measure.

Abnormal clinical laboratory values (serum chemistry and hematology) were reported as AEs if they were considered by the investigator to be a clinically significant change from Baseline or led to premature discontinuation of study treatment, dose modification, or other therapeutic intervention.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin 1.4 mg/kg: Phase 1 n=3 Participants Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 n=9 Participants Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1) Hyperuricaemia	0 Participants	1 Participants	—
Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1) Gamma-glutamyltransferase increased	0 Participants	1 Participants	—
Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1) Transaminases increased	0 Participants	1 Participants	—
Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1) Lymphocyte count decreased	1 Participants	1 Participants	—
Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1) Neutrophil count decreased	0 Participants	1 Participants	—
Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1) Blood bicarbonate decreased	0 Participants	1 Participants	—
Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1) Weight decreased	0 Participants	1 Participants	—
Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1) Hypocalaemia	0 Participants	2 Participants	—

PRIMARY outcome

Timeframe: From the first dose through 30 days after the last dose of study medication (Up to 15 months)

Population: Safety population is defined as all participants who received at least 1 dose of study drug. Participants enrolled in Phase 1 of study were evaluated for this outcome measure.

Vital signs measurements included supine (after 3-5 minutes in this position) and standing (after 3-5 minutes in this position) measurements of diastolic and systolic blood pressure, heart rate, and oral temperature.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin 1.4 mg/kg: Phase 1 n=3 Participants Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 n=9 Participants Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Number of Participants With Clinically Significant Vital Signs Values Reported as AEs (Phase 1)	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose

Population: Data for this outcome measure was not summarized for Phase 1 participants only, data was summarized together for Phase 1 and 2 participants in brentuximab 1.4 mg/kg and 1.8 mg/kg arms groups. Data has been presented in OM 19.

Blood samples were collected and tested for serum concentrations of brentuximab vedotin antibody-drug conjugate.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose

Blood samples were collected and tested for conjugated and unconjugated antibodies.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose

Blood samples were collected and tested for MMAE plasma concentrations.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or end of treatment (EOT) (Up to 15 months)

Population: Response-evaluable population included participants who received at least 1 dose of study drug, have measurable disease at baseline, and 1 postbaseline disease assessment. Data was summarized together for Phase 1 and 2 participants in brentuximab 1.8 mg/kg arm group.

Overall response rate is defined as the percentage of participants with complete remission (CR) or partial remission (PR) as assessed by an independent review facility (IRF) using International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin 1.4 mg/kg: Phase 1 n=3 Participants Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 n=15 Participants Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only n=17 Participants Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Overall Response Rate (ORR) (Phase 1 and 2)	0 percentage of participants Interval 0.0 to 71.0	47 percentage of participants Interval 21.0 to 73.0	53 percentage of participants Interval 28.0 to 77.0

SECONDARY outcome

Timeframe: Baseline up to EOT (Up to 15 months)

Population: Participants from the Safety Population, all enrolled participants who received at least one dose of brentuximab vedotin, with data available for analysis.

Blood samples were collected to assess the immunogenicity of brentuximab vedotin (ATA and nATA development) using a laboratory test. ATA-positive samples were further characterized as transiently ATA positive (defined as 1 or 2 post-Baseline ATA-positive responses), persistently ATA positive (defined as more than 2 post-Baseline ATA positive responses), and nATA positive or negative.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin 1.4 mg/kg: Phase 1 n=3 Participants Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 n=16 Participants Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only n=17 Participants Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Number of Participants With Antitherapeutic Antibodies (ATA) and Neutralizing ATA (nATA) (Phase 1 and 2) ATA status: Persistently positive	0 Participants	2 Participants	0 Participants
Number of Participants With Antitherapeutic Antibodies (ATA) and Neutralizing ATA (nATA) (Phase 1 and 2) ATA status: Transiently positive	1 Participants	4 Participants	7 Participants
Number of Participants With Antitherapeutic Antibodies (ATA) and Neutralizing ATA (nATA) (Phase 1 and 2) nATA status: Positive	0 Participants	5 Participants	4 Participants

SECONDARY outcome

Timeframe: Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT (Up to 15 months)

Population: Response-evaluable population included participants who received at least 1 dose of study drug, have measurable disease at baseline, and 1 postbaseline disease assessment. Participants enrolled in Phase 1 of the study were evaluated for this outcome measure.

Overall response rate is defined as the percentage of participants with CR or PR as assessed by an IRF using IWG Revised Response Criteria for Malignant Lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin 1.4 mg/kg: Phase 1 n=3 Participants Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 n=8 Participants Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Overall Response Rate (ORR) (Phase 1)	0 percentage of participants Interval 0.0 to 71.0	63 percentage of participants Interval 24.0 to 91.0	—

SECONDARY outcome

Timeframe: Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT and then every 12 weeks for 12 months after EOT, until disease progression, or death (Up to 27 months)

Population: Safety population is defined as all participants who received at least 1 dose of study drug. TTP was censored on last radiological assessment of measured lesions documenting absence of PD for participants who did not have tumor progression.

TTP is defined as the time in months from first dose until the first subsequent documentation of objective tumor progression. Progressive disease (PD) is defined as any new lesion or increase by ≥50% of previously involved sites from nadir.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin 1.4 mg/kg: Phase 1 n=3 Participants Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 n=16 Participants Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only n=17 Participants Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Time to Progression (TTP) (Phase 1 and 2)	2.7 months Interval 1.4 to 2.8	4.8 months Interval 1.2 to Upper limit of CI was not reached due to low number of participants with events.	6.2 months Interval 2.8 to Upper limit of CI was not reached due to low number of participants with events.

SECONDARY outcome

Timeframe: Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT (Up to 15 months)

Population: Response-evaluable population included participants who received at least 1 dose of study drug, have measurable disease at baseline, and 1 postbaseline disease assessment. Time to response was censored on the last radiological assessment of measured lesions documenting absence of CR or PR for participants who did not have CR or PR.

Time to response is defined as the time in months from the first dose of study treatment until the date of the first assessment of confirmed CR or PR. as assessed by an IRF using IWG revised response criteria for malignant lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin 1.4 mg/kg: Phase 1 n=3 Participants Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 n=15 Participants Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only n=17 Participants Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Time to Response (Phase 1 and 2)	NA months Median was not reached as no participant had response.	2.7 months Interval 1.3 to Upper limit of CI was not reached due to low number of participants with events.	1.5 months Interval 1.2 to Upper limit of CI was not reached due to low number of participants with events.

SECONDARY outcome

Timeframe: Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT and then every 12 weeks for 12 months after EOT, until disease progression, or death or end of study (Up to 72 months)

Population: Participants with response from the Safety Population, all enrolled participants who received at least one dose of brentuximab vedotin, with data available for analysis. Duration of response was censored at last observation documenting absence of PD for participants who did not have tumor progression.

DOR is defined as the time in months from the date of first documentation of a CR or PR to the date of first documentation of tumor progression or PD per IRF assessment according to IWG criteria or to death due to any cause, whichever comes first. CR is defined as the disappearance of all evidence of disease and PD is defined as any new lesion or increase by \>50% of previously involved sites from nadir.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin 1.4 mg/kg: Phase 1 Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 n=7 Participants Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only n=9 Participants Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Duration of Response (DOR) (Phase 1 and 2)	—	NA months Interval 2.2 to Median and upper limit of CI was not reached due to low number of participants with events.	30.3 months Interval 3.4 to 30.3

SECONDARY outcome

Timeframe: Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT and then every 12 weeks for 12 months after EOT, until disease progression, or death (Up to 27 months)

Population: Safety population is defined as all participants who received at least 1 dose of study drug. EFS was censored on the last follow-up date if none of the above events occur during the study.

EFS is defined as the time in months from first dose until any cause of treatment failure: disease progression, premature discontinuation of treatment for any reason, or death due to any cause, whichever occurs first. PD is defined as any new lesion or increase by \>50% of previously involved sites from nadir.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin 1.4 mg/kg: Phase 1 n=3 Participants Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 n=16 Participants Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only n=17 Participants Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Event Free Survival (EFS) (Phase 1 and 2)	2.7 months Interval 1.4 to 2.8	2.1 months Interval 1.2 to 4.8	4.8 months Interval 2.8 to 7.4

SECONDARY outcome

Population: Safety population is defined as all participants who received at least 1 dose of study drug. PFS was censored on the day following the date of last radiological assessment of measured lesions documenting absence of PD for participants who did not have tumor progression.

PFS is defined as time in months from start of study treatment to first documentation of objective tumor progression per IRF assessment or up to death due to any cause, whichever occurs first. PD is defined as any new lesion or increase by \>50% of previously involved sites from nadir.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin 1.4 mg/kg: Phase 1 n=3 Participants Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 n=16 Participants Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only n=17 Participants Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Progression Free Survival (PFS) (Phase 1 and 2)	2.7 months Interval 1.4 to 2.8	3.8 months Interval 1.2 to Upper limit of CI was not reached due to low number of participants with events.	6.2 months Interval 2.8 to 31.5

SECONDARY outcome

Timeframe: Every 6 months after EOT, until the sooner of death, study closure, or 2 years after enrolment of the last participant (Up to 72 months)

Population: Safety population is defined as all participants who received at least 1 dose of study drug.

OS is the time in months from start of study treatment to date of death due to any cause.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin 1.4 mg/kg: Phase 1 n=3 Participants Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 n=16 Participants Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only n=17 Participants Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Overall Survival (OS) (Phase 1 and 2)	NA months Median was not reached due to low number of participants with events.	NA months Median was not reached due to low number of participants with events.	NA months Median was not reached due to low number of participants with events.

SECONDARY outcome

Timeframe: From the first dose through 30 days after the last dose of study medication (up to 15 months)

Population: Safety population is defined as all participants who received at least 1 dose of study drug. Data was summarized together for Phase 1 and 2 participants in brentuximab 1.8 mg/kg arm group.

An 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. A SAE is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. AE severity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin 1.4 mg/kg: Phase 1 n=3 Participants Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 n=16 Participants Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only n=17 Participants Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Phase 1 and 2) TEAEs	3 Participants	16 Participants	17 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Phase 1 and 2) SAEs	0 Participants	7 Participants	1 Participants

SECONDARY outcome

Timeframe: From the first dose through 30 days after the last dose of study medication (Up to 15 months)

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin 1.4 mg/kg: Phase 1 n=3 Participants Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 n=16 Participants Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only n=17 Participants Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1 and 2) White blood cell count decreased	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1 and 2) Gamma-glutamyltransferase increased	0 Participants	2 Participants	0 Participants
Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1 and 2) Alanine aminotransferase increased	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1 and 2) Aspartate aminotransferase increased	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1 and 2) Transaminases increased	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1 and 2) Lymphocyte count decreased	1 Participants	0 Participants	2 Participants
Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1 and 2) Neutrophil count decreased	0 Participants	0 Participants	2 Participants
Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1 and 2) Blood bicarbonate decreased	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1 and 2) Weight decreased	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1 and 2) C-reactive protein increased	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1 and 2) Blood alkaline phosphatase increased	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From the first dose through 30 days after the last dose of study medication (Up to 15 months)

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin 1.4 mg/kg: Phase 1 n=3 Participants Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 n=16 Participants Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only n=17 Participants Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Number of Participants With Clinically Significant Vital Signs Reported as AEs (Phase 1 and 2)	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose

Population: PK-evaluable population was defined as participants with sufficient dosing and PK data to reliably estimate PK parameters. Cycle 2 Day 2 values are collected in phase 1 participants only. Here, number analyzed is number of participants assessed at given time-point. Data summarized together for all participants in brentuximab vedotin 1.8 mg/kg arm.

Blood samples were collected and tested for serum concentrations of brentuximab vedotin antibody-drug conjugate.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin 1.4 mg/kg: Phase 1 n=3 Participants Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 n=33 Participants Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 7 Day 1, 5 minutes Post-Dose	17.9 ug/mL Standard Deviation 2.40	32.3 ug/mL Standard Deviation 15.4	—
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 8 Day 1, Pre-Dose	—	1.25 ug/mL Standard Deviation 0.565	—
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 13 Day 1, 5 minutes Post-Dose	—	33.3 ug/mL Standard Deviation 16.1	—
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 14 Day 1, Pre-Dose	—	1.60 ug/mL Standard Deviation 0.600	—
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 14 Day 1, 5 minutes Post-Dose	—	37.0 ug/mL Standard Deviation 7.92	—
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 15 Day 1, Pre-Dose	—	1.48 ug/mL Standard Deviation 0.542	—
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 15 Day 1, 5 minutes Post-Dose	—	40.3 ug/mL Standard Deviation 10.6	—
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 16 Day 1, Pre-Dose	—	1.52 ug/mL Standard Deviation 0.361	—
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 1 Day 1, Pre-Dose	—	NA ug/mL Standard Deviation NA Data was below the limit of quantification.	—
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 1 Day 1, 5 Minutes Post-Dose	23.1 ug/mL Standard Deviation 3.46	31.8 ug/mL Standard Deviation 12.4	—
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 1 Day 2, 24 Hours Post-Dose	9.50 ug/mL Standard Deviation 1.73	13.0 ug/mL Standard Deviation 5.34	—
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 1 Day 3, 48 Hours Post-Dose	5.67 ug/mL Standard Deviation 0.924	12.0 ug/mL Standard Deviation 16.3	—
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 1 Day 5, 96 Hours Post-Dose	3.50 ug/mL Standard Deviation 1.41	8.68 ug/mL Standard Deviation 13.4	—
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 1 Day 14, 312 Hours Post-Dose	0.844 ug/mL Standard Deviation 0.309	2.19 ug/mL Standard Deviation 3.44	—
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 2 Day 1, Pre-Dose	0.149 ug/mL Standard Deviation 0.128	0.395 ug/mL Standard Deviation 0.322	—
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 2 Day 1, 5-minutes Post-Dose	25.3 ug/mL Standard Deviation 7.56	32.9 ug/mL Standard Deviation 9.80	—
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 2 Day 2, 24 Hours Post-Dose	8.80 ug/mL Standard Deviation 6.19	10.4 ug/mL Standard Deviation 8.05	—
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 2 Day 3, 48 Hours Post-Dose	3.70 ug/mL Standard Deviation 1.95	11.4 ug/mL Standard Deviation 16.8	—
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 2 Day 5, 96 Hours Post-Dose	2.04 ug/mL Standard Deviation 1.26	9.61 ug/mL Standard Deviation 17.9	—
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 3 Day 1, Pre-Dose	0.116 ug/mL Standard Deviation 0.163	0.491 ug/mL Standard Deviation 0.387	—
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 3 Day 1, 5 minutes Post-Dose	23.9 ug/mL Standard Deviation 2.83	31.3 ug/mL Standard Deviation 9.79	—
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 4 Day 1, Pre-dose	0.218 ug/mL Standard Deviation 0.271	0.691 ug/mL Standard Deviation 0.492	—
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 4 Day 1, 5 minutes Post-Dose	22.9 ug/mL Standard Deviation 4.60	30.0 ug/mL Standard Deviation 12.2	—
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 5 Day 1, Pre-Dose	0.264 ug/mL Standard Deviation 0.321	0.845 ug/mL Standard Deviation 0.564	—
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 5 Day 1, 5 minutes Post-Dose	22.5 ug/mL Standard Deviation 3.32	30.6 ug/mL Standard Deviation 15.1	—
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 6 Day 1, Pre-Dose	0.312 ug/mL Standard Deviation 0.351	1.06 ug/mL Standard Deviation 0.699	—
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 6 Day 1, 5 minutes Post-Dose	20.3 ug/mL Standard Deviation 4.38	33.2 ug/mL Standard Deviation 16.1	—
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 7 Day 1, Pre-Dose	0.327 ug/mL Standard Deviation 0.337	1.04 ug/mL Standard Deviation 0.618	—
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 8 Day 1, 5 minutes Post-Dose	—	35.2 ug/mL Standard Deviation 10.5	—
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 8 Day 2, 24 Hours Post-Dose	—	14.0 ug/mL Standard Deviation 4.55	—
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 8 Day 3, 48 Hours Post-Dose	—	9.53 ug/mL Standard Deviation 2.96	—
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 8 Day 5, 96 Hours Post-Dose	—	6.44 ug/mL Standard Deviation 2.35	—
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 8 Day 14, 312 Hours Post-Dose	—	3.30 ug/mL Standard Deviation 4.63	—
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 9 Day 1, Pre-Dose	—	4.37 ug/mL Standard Deviation 11.7	—
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 9 Day 1, 5 Minutes Post-Dose	—	29.6 ug/mL Standard Deviation 11.3	—
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 10 Day 1, Pre-Dose	—	1.20 ug/mL Standard Deviation 0.455	—
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 10 Day 1, 5 minutes Post-Dose	—	35.7 ug/mL Standard Deviation 9.50	—
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 11 Day 1, Pre-Dose	—	1.84 ug/mL Standard Deviation 1.57	—
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 11 Day 1, 5 minutes Post-Dose	—	35.7 ug/mL Standard Deviation 10.8	—
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 12 Day 1, Pre-Dose	—	1.47 ug/mL Standard Deviation 0.665	—
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 12 Day 1, 5 minutes Post-Dose	—	40.0 ug/mL Standard Deviation 10.4	—
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 13 Day 1, Pre-Dose	—	6.28 ug/mL Standard Deviation 11.5	—
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2) Cycle 16 Day 1, 5 minutes Post-Dose	—	41.5 ug/mL Standard Deviation 4.70	—

SECONDARY outcome

Timeframe: Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose

Blood samples were collected and tested for conjugated and unconjugated antibodies.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin 1.4 mg/kg: Phase 1 n=3 Participants Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 n=33 Participants Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 6 Day 1, 5 minutes Post-Dose	29.4 ug/mL Standard Deviation 5.37	39.8 ug/mL Standard Deviation 19.8	—
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 7 Day 1, Pre-Dose	0.995 ug/mL Standard Deviation 0.998	2.92 ug/mL Standard Deviation 1.62	—
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 7 Day 1, 5 minutes Post-Dose	24.0 ug/mL Standard Deviation 2.69	41.0 ug/mL Standard Deviation 21.2	—
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 14 Day 1, 5 minutes Post-Dose	—	44.5 ug/mL Standard Deviation 7.05	—
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 15 Day 1, Pre-Dose	—	4.02 ug/mL Standard Deviation 1.40	—
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 15 Day 1, 5 minutes Post-Dose	—	49.7 ug/mL Standard Deviation 6.88	—
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 1 Day 1, Pre-Dose	NA ug/mL Standard Deviation NA Data was below the limit of quantification.	NA ug/mL Standard Deviation NA Data was below the limit of quantification.	—
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 1 Day 1, 5 Minutes Post-Dose	26.3 ug/mL Standard Deviation 2.29	34.7 ug/mL Standard Deviation 13.4	—
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 1 Day 2, 24 Hours Post-Dose	16.7 ug/mL Standard Deviation 1.50	25.0 ug/mL Standard Deviation 9.59	—
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 1 Day 3, 48 Hours Post-Dose	12.7 ug/mL Standard Deviation 3.13	18.5 ug/mL Standard Deviation 7.57	—
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 1 Day 5, 96 Hours Post-Dose	8.63 ug/mL Standard Deviation 5.11	11.8 ug/mL Standard Deviation 5.02	—
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 1 Day 14, 312 Hours Post-Dose	2.23 ug/mL Standard Deviation 0.833	3.50 ug/mL Standard Deviation 1.70	—
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 2 Day 1, Pre-Dose	0.470 ug/mL Standard Deviation 0.459	1.16 ug/mL Standard Deviation 0.825	—
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 2 Day 1, 5-minutes Post-Dose	26.9 ug/mL Standard Deviation 7.98	35.6 ug/mL Standard Deviation 12.0	—
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 2 Day 2, 24 Hours Post-Dose	17.1 ug/mL Standard Deviation 10.4	17.2 ug/mL Standard Deviation 7.93	—
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 2 Day 3, 48 Hours Post-Dose	9.60 ug/mL Standard Deviation 5.39	16.0 ug/mL Standard Deviation 6.73	—
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 2 Day 3, 96 Hours Post-Dose	6.43 ug/mL Standard Deviation 3.69	10.2 ug/mL Standard Deviation 5.16	—
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 3 Day 1, Pre-Dose	0.415 ug/mL Standard Deviation 0.586	1.62 ug/mL Standard Deviation 1.07	—
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 3 Day 1, 5 minutes Post-Dose	30.0 ug/mL Standard Deviation 5.87	38.2 ug/mL Standard Deviation 13.1	—
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 4 Day 1, Pre-dose	0.875 ug/mL Standard Deviation 1.03	1.95 ug/mL Standard Deviation 1.26	—
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 4 Day 1, 5 minutes Post-Dose	29.6 ug/mL Standard Deviation 8.13	37.1 ug/mL Standard Deviation 15.6	—
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 5 Day 1, Pre-Dose	0.844 ug/mL Standard Deviation 0.928	2.45 ug/mL Standard Deviation 1.68	—
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 5 Day 1, 5 minutes Post-Dose	29.4 ug/mL Standard Deviation 3.04	38.0 ug/mL Standard Deviation 18.8	—
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 6 Day 1, Pre-Dose	1.05 ug/mL Standard Deviation 1.20	2.99 ug/mL Standard Deviation 1.81	—
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 8 Day 1, Pre-Dose	—	3.29 ug/mL Standard Deviation 1.14	—
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 8 Day 1, 5 minutes Post-Dose	—	41.4 ug/mL Standard Deviation 9.47	—
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 8 Day 2, 24 Hours Post-Dose	—	28.2 ug/mL Standard Deviation 6.38	—
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 8 Day 3, 48 Hours Post-Dose	—	22.9 ug/mL Standard Deviation 5.67	—
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 8 Day 5, 96 Hours Post-Dose	—	17.3 ug/mL Standard Deviation 4.93	—
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 8 Day 14, 312 Hours Post-Dose	—	5.74 ug/mL Standard Deviation 2.02	—
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 9 Day 1, Pre-Dose	—	6.30 ug/mL Standard Deviation 12.0	—
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 9 Day 1, 5 Minutes Post-Dose	—	35.1 ug/mL Standard Deviation 11.3	—
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 10 Day 1, Pre-Dose	—	3.48 ug/mL Standard Deviation 1.13	—
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 10 Day 1, 5 minutes Post-Dose	—	41.4 ug/mL Standard Deviation 8.63	—
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 11 Day 1, Pre-Dose	—	3.96 ug/mL Standard Deviation 2.24	—
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 11 Day 1, 5 minutes Post-Dose	—	42.8 ug/mL Standard Deviation 8.85	—
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 12 Day 1, Pre-Dose	—	3.47 ug/mL Standard Deviation 1.28	—
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 12 Day 1, 5 minutes Post-Dose	—	44.8 ug/mL Standard Deviation 10.3	—
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 13 Day 1, Pre-Dose	—	11.3 ug/mL Standard Deviation 17.1	—
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 13 Day 1, 5 minutes Post-Dose	NA ug/mL Standard Deviation NA No participant was analyzed in this arm group at this time point.	40.3 ug/mL Standard Deviation 19.2	—
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 14 Day 1, Pre-Dose	—	3.97 ug/mL Standard Deviation 1.14	—
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 16 Day 1, Pre-Dose	—	4.60 ug/mL Standard Deviation 1.67	—
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) Cycle 16 Day 1, 5 minutes Post-Dose	—	49.7 ug/mL Standard Deviation 7.61	—

SECONDARY outcome

Timeframe: Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose

Blood samples were collected and tested for MMAE plasma concentrations.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin 1.4 mg/kg: Phase 1 n=3 Participants Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 n=33 Participants Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 1 Day 2, 24 Hours Post-Dose	4.63 ng/mL Standard Deviation 3.20	4.88 ng/mL Standard Deviation 3.55	—
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 1 Day 3, 48 Hours Post-Dose	4.20 ng/mL Standard Deviation 1.95	5.36 ng/mL Standard Deviation 3.72	—
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 3 Day 1, Pre-Dose	0.0250 ng/mL Standard Deviation 0.0354	0.0650 ng/mL Standard Deviation 0.0590	—
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 3 Day 1, 5 minutes Post-Dose	0.216 ng/mL Standard Deviation 0.0361	0.514 ng/mL Standard Deviation 0.684	—
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 1 Day 1, Pre-Dose	NA ng/mL Standard Deviation NA Data was below the limit of quantification.	NA ng/mL Standard Deviation NA Data was below the limit of quantification.	—
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 1 Day 1, 5 Minutes Post-Dose	0.416 ng/mL Standard Deviation 0.480	0.368 ng/mL Standard Deviation 0.309	—
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 1 Day 5, 96 Hours Post-Dose	2.80 ng/mL Standard Deviation 0.300	4.43 ng/mL Standard Deviation 3.04	—
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 1 Day 14, 312 Hours Post-Dose	0.196 ng/mL Standard Deviation 0.0641	0.530 ng/mL Standard Deviation 0.552	—
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 2 Day 1, Pre-Dose	0.0647 ng/mL Standard Deviation 0.0358	0.0739 ng/mL Standard Deviation 0.0640	—
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 2 Day 1, 5-minutes Post-Dose	0.556 ng/mL Standard Deviation 0.562	0.478 ng/mL Standard Deviation 0.461	—
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 2 Day 2, 24 Hours Post-Dose	5.63 ng/mL Standard Deviation 5.72	3.71 ng/mL Standard Deviation 3.94	—
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 2 Day 3, 48 Hours Post-Dose	4.60 ng/mL Standard Deviation 3.70	3.86 ng/mL Standard Deviation 3.18	—
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 2 Day 5, 96 Hours Post-Dose	2.60 ng/mL Standard Deviation 1.04	2.70 ng/mL Standard Deviation 1.69	—
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 4 Day 1, Pre-dose	0.0565 ng/mL Standard Deviation 0.00495	0.0866 ng/mL Standard Deviation 0.0784	—
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 4 Day 1, 5 minutes Post-Dose	0.234 ng/mL Standard Deviation 0.0742	0.376 ng/mL Standard Deviation 0.449	—
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 5 Day 1, Pre-Dose	0.0820 ng/mL Standard Deviation NA Standard deviation was not estimable for 2 participants.	0.0862 ng/mL Standard Deviation 0.0729	—
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 5 Day 1, 5 minutes Post-Dose	0.334 ng/mL Standard Deviation 0.0955	0.301 ng/mL Standard Deviation 0.248	—
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 6 Day 1, Pre-Dose	0.0680 ng/mL Standard Deviation 0.0156	0.0841 ng/mL Standard Deviation 0.0632	—
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 6 Day 1, 5 minutes Post-Dose	0.247 ng/mL Standard Deviation 0.00707	0.450 ng/mL Standard Deviation 0.663	—
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 7 Day 1, Pre-Dose	0.104 ng/mL Standard Deviation 0.0389	0.0830 ng/mL Standard Deviation 0.0578	—
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 7 Day 1, 5 minutes Post-Dose	0.326 ng/mL Standard Deviation 0.0361	0.310 ng/mL Standard Deviation 0.282	—
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 8 Day 1, Pre-Dose	—	0.101 ng/mL Standard Deviation 0.934	—
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 8 Day 1, 5 minutes Post-Dose	—	0.295 ng/mL Standard Deviation 0.151	—
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 8 Day 2, 24 Hours Post-Dose	—	1.96 ng/mL Standard Deviation 1.31	—
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 8 Day 3, 48 Hours Post-Dose	—	1.91 ng/mL Standard Deviation 1.29	—
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 8 Day 5, 96 Hours Post-Dose	—	2.00 ng/mL Standard Deviation 1.05	—
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 8 Day 14, 312 Hours Post-Dose	—	0.325 ng/mL Standard Deviation 0.214	—
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 9 Day 1, Pre-Dose	—	0.0819 ng/mL Standard Deviation 0.0496	—
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 9 Day 1, 5 Minutes Post-Dose	—	0.218 ng/mL Standard Deviation 0.128	—
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 10 Day 1, Pre-Dose	—	0.727 ng/mL Standard Deviation 0.0517	—
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 10 Day 1, 5 minutes Post-Dose	—	0.204 ng/mL Standard Deviation 0.0982	—
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 11 Day 1, Pre-Dose	—	0.0763 ng/mL Standard Deviation 0.0368	—
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 11 Day 1, 5 minutes Post-Dose	—	0.255 ng/mL Standard Deviation 0.133	—
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 12 Day 1, Pre-Dose	—	0.105 ng/mL Standard Deviation 0.0983	—
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 12 Day 1, 5 minutes Post-Dose	—	0.252 ng/mL Standard Deviation 0.116	—
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 13 Day 1, Pre-Dose	—	0.110 ng/mL Standard Deviation 0.0629	—
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 13 Day 1, 5 minutes Post-Dose	—	0.244 ng/mL Standard Deviation 0.130	—
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 14 Day 1, Pre-Dose	—	0.109 ng/mL Standard Deviation 0.0529	—
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 14 Day 1, 5 minutes Post-Dose	—	0.320 ng/mL Standard Deviation 0.138	—
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 15 Day 1, Pre-Dose	—	0.0843 ng/mL Standard Deviation 0.0548	—
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 15 Day 1, 5 minutes Post-Dose	—	0.404 ng/mL Standard Deviation 0.192	—
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 16 Day 1, Pre-Dose	—	0.139 ng/mL Standard Deviation 0.0926	—
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2) Cycle 16 Day 1, 5 minutes Post-Dose	—	0.381 ng/mL Standard Deviation 0.277	—

Adverse Events

Brentuximab Vedotin 1.4 mg/kg: Phase 1

Serious events: 0 serious events

Other events: 3 other events

Deaths: 1 deaths

Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only

Serious events: 7 serious events

Other events: 16 other events

Deaths: 6 deaths

Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only

Serious events: 1 serious events

Other events: 17 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Brentuximab Vedotin 1.4 mg/kg: Phase 1 n=3 participants at risk Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only n=16 participants at risk Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.	Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only n=17 participants at risk Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Hepatobiliary disorders Hepatotoxicity	0.00% 0/3 • From the first dose through 30 days after the last dose of study medication (Up to 15 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. At the time of study completion, a total of 9 deaths were reported for the safety population, 1 on study death (death within 30 days of last dose) and 8 deaths during post-treatment follow up (PTFU).	6.2% 1/16 • From the first dose through 30 days after the last dose of study medication (Up to 15 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. At the time of study completion, a total of 9 deaths were reported for the safety population, 1 on study death (death within 30 days of last dose) and 8 deaths during post-treatment follow up (PTFU).	0.00% 0/17 • From the first dose through 30 days after the last dose of study medication (Up to 15 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. At the time of study completion, a total of 9 deaths were reported for the safety population, 1 on study death (death within 30 days of last dose) and 8 deaths during post-treatment follow up (PTFU).
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/3 • From the first dose through 30 days after the last dose of study medication (Up to 15 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. At the time of study completion, a total of 9 deaths were reported for the safety population, 1 on study death (death within 30 days of last dose) and 8 deaths during post-treatment follow up (PTFU).	6.2% 1/16 • From the first dose through 30 days after the last dose of study medication (Up to 15 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. At the time of study completion, a total of 9 deaths were reported for the safety population, 1 on study death (death within 30 days of last dose) and 8 deaths during post-treatment follow up (PTFU).	0.00% 0/17 • From the first dose through 30 days after the last dose of study medication (Up to 15 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. At the time of study completion, a total of 9 deaths were reported for the safety population, 1 on study death (death within 30 days of last dose) and 8 deaths during post-treatment follow up (PTFU).
Infections and infestations Pneumonia	0.00% 0/3 • From the first dose through 30 days after the last dose of study medication (Up to 15 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. At the time of study completion, a total of 9 deaths were reported for the safety population, 1 on study death (death within 30 days of last dose) and 8 deaths during post-treatment follow up (PTFU).	6.2% 1/16 • From the first dose through 30 days after the last dose of study medication (Up to 15 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. At the time of study completion, a total of 9 deaths were reported for the safety population, 1 on study death (death within 30 days of last dose) and 8 deaths during post-treatment follow up (PTFU).	0.00% 0/17 • From the first dose through 30 days after the last dose of study medication (Up to 15 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. At the time of study completion, a total of 9 deaths were reported for the safety population, 1 on study death (death within 30 days of last dose) and 8 deaths during post-treatment follow up (PTFU).
General disorders Pyrexia	0.00% 0/3 • From the first dose through 30 days after the last dose of study medication (Up to 15 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. At the time of study completion, a total of 9 deaths were reported for the safety population, 1 on study death (death within 30 days of last dose) and 8 deaths during post-treatment follow up (PTFU).	6.2% 1/16 • From the first dose through 30 days after the last dose of study medication (Up to 15 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. At the time of study completion, a total of 9 deaths were reported for the safety population, 1 on study death (death within 30 days of last dose) and 8 deaths during post-treatment follow up (PTFU).	5.9% 1/17 • From the first dose through 30 days after the last dose of study medication (Up to 15 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. At the time of study completion, a total of 9 deaths were reported for the safety population, 1 on study death (death within 30 days of last dose) and 8 deaths during post-treatment follow up (PTFU).
Gastrointestinal disorders Vomiting	0.00% 0/3 • From the first dose through 30 days after the last dose of study medication (Up to 15 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. At the time of study completion, a total of 9 deaths were reported for the safety population, 1 on study death (death within 30 days of last dose) and 8 deaths during post-treatment follow up (PTFU).	6.2% 1/16 • From the first dose through 30 days after the last dose of study medication (Up to 15 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. At the time of study completion, a total of 9 deaths were reported for the safety population, 1 on study death (death within 30 days of last dose) and 8 deaths during post-treatment follow up (PTFU).	0.00% 0/17 • From the first dose through 30 days after the last dose of study medication (Up to 15 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. At the time of study completion, a total of 9 deaths were reported for the safety population, 1 on study death (death within 30 days of last dose) and 8 deaths during post-treatment follow up (PTFU).
Immune system disorders Anaphylactic reaction	0.00% 0/3 • From the first dose through 30 days after the last dose of study medication (Up to 15 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. At the time of study completion, a total of 9 deaths were reported for the safety population, 1 on study death (death within 30 days of last dose) and 8 deaths during post-treatment follow up (PTFU).	6.2% 1/16 • From the first dose through 30 days after the last dose of study medication (Up to 15 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. At the time of study completion, a total of 9 deaths were reported for the safety population, 1 on study death (death within 30 days of last dose) and 8 deaths during post-treatment follow up (PTFU).	0.00% 0/17 • From the first dose through 30 days after the last dose of study medication (Up to 15 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. At the time of study completion, a total of 9 deaths were reported for the safety population, 1 on study death (death within 30 days of last dose) and 8 deaths during post-treatment follow up (PTFU).
Cardiac disorders Supraventricular tachycardia	0.00% 0/3 • From the first dose through 30 days after the last dose of study medication (Up to 15 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. At the time of study completion, a total of 9 deaths were reported for the safety population, 1 on study death (death within 30 days of last dose) and 8 deaths during post-treatment follow up (PTFU).	6.2% 1/16 • From the first dose through 30 days after the last dose of study medication (Up to 15 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. At the time of study completion, a total of 9 deaths were reported for the safety population, 1 on study death (death within 30 days of last dose) and 8 deaths during post-treatment follow up (PTFU).	0.00% 0/17 • From the first dose through 30 days after the last dose of study medication (Up to 15 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. At the time of study completion, a total of 9 deaths were reported for the safety population, 1 on study death (death within 30 days of last dose) and 8 deaths during post-treatment follow up (PTFU).
Cardiac disorders Cardiac arrest	0.00% 0/3 • From the first dose through 30 days after the last dose of study medication (Up to 15 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. At the time of study completion, a total of 9 deaths were reported for the safety population, 1 on study death (death within 30 days of last dose) and 8 deaths during post-treatment follow up (PTFU).	6.2% 1/16 • From the first dose through 30 days after the last dose of study medication (Up to 15 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. At the time of study completion, a total of 9 deaths were reported for the safety population, 1 on study death (death within 30 days of last dose) and 8 deaths during post-treatment follow up (PTFU).	0.00% 0/17 • From the first dose through 30 days after the last dose of study medication (Up to 15 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. At the time of study completion, a total of 9 deaths were reported for the safety population, 1 on study death (death within 30 days of last dose) and 8 deaths during post-treatment follow up (PTFU).
General disorders Myalgia	0.00% 0/3 • From the first dose through 30 days after the last dose of study medication (Up to 15 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. At the time of study completion, a total of 9 deaths were reported for the safety population, 1 on study death (death within 30 days of last dose) and 8 deaths during post-treatment follow up (PTFU).	6.2% 1/16 • From the first dose through 30 days after the last dose of study medication (Up to 15 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. At the time of study completion, a total of 9 deaths were reported for the safety population, 1 on study death (death within 30 days of last dose) and 8 deaths during post-treatment follow up (PTFU).	0.00% 0/17 • From the first dose through 30 days after the last dose of study medication (Up to 15 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. At the time of study completion, a total of 9 deaths were reported for the safety population, 1 on study death (death within 30 days of last dose) and 8 deaths during post-treatment follow up (PTFU).

Other adverse events

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

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