Trial Outcomes & Findings for Study of BGB-A317 in Participants With Relapsed or Refractory Mature T- and NK-cell Neoplasms (NCT NCT03493451)

Last Updated: 2024-10-26

Results Overview

ORR is defined as the percentage of participants achieving a best overall response of complete response or partial response as determined by the investigator using Lugano criteria with Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) modification for cohorts 1 and 2 and International Society for Cutaneous Lymphomas/European Organization of Research and Treatment of Cancer (ISCL/EORTC) guidelines for cohort 3.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

77 participants

Primary outcome timeframe

Up to approximately 3 years and 1 week

Results posted on

2024-10-26

Participant Flow

Participants were enrolled from study centers in Canada, China, France, Italy, and Taiwan, China.

Participant milestones

Participant milestones
Measure	Cohort 1: ENKTL Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)	Cohort 2: PTCL-NOS, AITL, and ALCL Participants with other R/R mature T-cell neoplasms \[limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)	Cohort 3: MF and SS Participants with R/R cutaneous T-cell lymphoma \[limited to mycosis fungoides (MF) and Sèzary syndrome (SS)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
Overall Study STARTED	22	44	11
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	22	44	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: ENKTL Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)	Cohort 2: PTCL-NOS, AITL, and ALCL Participants with other R/R mature T-cell neoplasms \[limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)	Cohort 3: MF and SS Participants with R/R cutaneous T-cell lymphoma \[limited to mycosis fungoides (MF) and Sèzary syndrome (SS)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
Overall Study Death	11	26	3
Overall Study Lost to Follow-up	1	4	1
Overall Study Withdrawal by Subject	1	1	2
Overall Study Progressive Disease	1	0	0
Overall Study Transferred to long term extension study	8	13	5

Baseline Characteristics

Study of BGB-A317 in Participants With Relapsed or Refractory Mature T- and NK-cell Neoplasms

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: ENKTL n=22 Participants Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)	Cohort 2: PTCL-NOS, AITL, and ALCL n=44 Participants Participants with other R/R mature T-cell neoplasms \[limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)	Cohort 3: MF and SS n=11 Participants Participants with R/R cutaneous T-cell lymphoma \[limited to mycosis fungoides (MF) and Sèzary syndrome (SS)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)	Total n=77 Participants Total of all reporting groups
Age, Continuous	51.5 Years STANDARD_DEVIATION 16.24 • n=5 Participants	55.8 Years STANDARD_DEVIATION 15.03 • n=7 Participants	59.4 Years STANDARD_DEVIATION 12.45 • n=5 Participants	55.1 Years STANDARD_DEVIATION 15.09 • n=4 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	15 Participants n=7 Participants	3 Participants n=5 Participants	26 Participants n=4 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	29 Participants n=7 Participants	8 Participants n=5 Participants	51 Participants n=4 Participants
Race/Ethnicity, Customized Asian	19 Participants n=5 Participants	23 Participants n=7 Participants	2 Participants n=5 Participants	44 Participants n=4 Participants
Race/Ethnicity, Customized White	2 Participants n=5 Participants	18 Participants n=7 Participants	8 Participants n=5 Participants	28 Participants n=4 Participants
Race/Ethnicity, Customized Not Reported	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Region of Enrollment Canada	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment China	19 Participants n=5 Participants	22 Participants n=7 Participants	0 Participants n=5 Participants	41 Participants n=4 Participants
Region of Enrollment Taiwan	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment Italy	2 Participants n=5 Participants	18 Participants n=7 Participants	8 Participants n=5 Participants	28 Participants n=4 Participants
Region of Enrollment France	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants

PRIMARY outcome

Timeframe: Up to approximately 3 years and 1 week

Population: Safety analysis set includes all participants who received at least one dose of study drug

Outcome measures

Outcome measures
Measure	Cohort 1: ENKTL n=22 Participants Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)	Cohort 2: PTCL-NOS, AITL, and ALCL n=44 Participants Participants with other R/R mature T-cell neoplasms \[limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)	Cohort 3: MF and SS n=11 Participants Participants with R/R cutaneous T-cell lymphoma \[limited to mycosis fungoides (MF) and Sèzary syndrome (SS)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
Overall Response Rate (ORR)	31.8 Percentage of participants Interval 13.9 to 54.9	20.5 Percentage of participants Interval 9.8 to 35.3	45.5 Percentage of participants Interval 16.7 to 76.6

SECONDARY outcome

Timeframe: Up to approximately 3 years and 1 week

Population: Safety analysis set includes all participants who received at least one dose of study drug; Duration of response was summarized for responders (participants who achieved a partial or complete response).

DOR defined as the time from the first determination of an objective response until progression or death, whichever occurs first, as assessed by the investigator using Lugano criteria with LYRIC modification for cohorts 1 and 2 and ISCL/EORTC guidelines for cohort 3.

Outcome measures

Outcome measures
Measure	Cohort 1: ENKTL n=7 Participants Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)	Cohort 2: PTCL-NOS, AITL, and ALCL n=9 Participants Participants with other R/R mature T-cell neoplasms \[limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)	Cohort 3: MF and SS n=5 Participants Participants with R/R cutaneous T-cell lymphoma \[limited to mycosis fungoides (MF) and Sèzary syndrome (SS)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
Duration of Response (DOR)	NA Months Interval 2.66 to Not estimable due to insufficient number of participants with events (progressive disease or death)	8.2 Months Interval 2.5 to Not estimable due to insufficient number of participants with events (progressive disease or death)	11.3 Months Interval 2.76 to 11.3

SECONDARY outcome

Timeframe: Up to approximately 3 years and 1 week

Population: Safety analysis set includes all participants who received at least one dose of study drug

PFS is defined as the time from first study drug administration to the date of disease progression or death, whichever occurs first, as assessed by the investigator using Lugano criteria with LYRIC modification for cohorts 1 and 2 and ISCL/EORTC guidelines for cohort 3.

Outcome measures

Outcome measures
Measure	Cohort 1: ENKTL n=22 Participants Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)	Cohort 2: PTCL-NOS, AITL, and ALCL n=44 Participants Participants with other R/R mature T-cell neoplasms \[limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)	Cohort 3: MF and SS n=11 Participants Participants with R/R cutaneous T-cell lymphoma \[limited to mycosis fungoides (MF) and Sèzary syndrome (SS)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
Progression-free Survival (PFS)	2.7 Months Interval 1.45 to 5.32	2.7 Months Interval 2.56 to 4.76	16.8 Months Interval 2.6 to 16.82

SECONDARY outcome

Timeframe: Up to approximately 3 years and 1 week

Population: Safety analysis set includes all participants who received at least one dose of study drug

OS defined as the time from first study drug administration to the date of death due to any reason for cohorts 1 and 2.

Outcome measures

Outcome measures
Measure	Cohort 1: ENKTL n=22 Participants Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)	Cohort 2: PTCL-NOS, AITL, and ALCL n=44 Participants Participants with other R/R mature T-cell neoplasms \[limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)	Cohort 3: MF and SS Participants with R/R cutaneous T-cell lymphoma \[limited to mycosis fungoides (MF) and Sèzary syndrome (SS)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
Overall Survival (OS)	8.8 Months Interval 3.25 to Upper limit of confidence interval not estimable due to insufficient number of participants with events	13.3 Months Interval 7.66 to 26.22	—

SECONDARY outcome

Timeframe: Up to approximately 3 years and 1 week

Population: Safety analysis set includes all participants who received at least one dose of study drug

CRR is defined as the percentage of participants who achieve complete response or complete metabolic response as best overall response as assessed by the investigator using Lugano criteria with LYRIC modification for cohorts 1 and 2 and ISCL/EORTC guidelines for cohort 3.

Outcome measures

Outcome measures
Measure	Cohort 1: ENKTL n=22 Participants Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)	Cohort 2: PTCL-NOS, AITL, and ALCL n=44 Participants Participants with other R/R mature T-cell neoplasms \[limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)	Cohort 3: MF and SS n=11 Participants Participants with R/R cutaneous T-cell lymphoma \[limited to mycosis fungoides (MF) and Sèzary syndrome (SS)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
Complete Response Rate (CRR)	18.2 Percentage of participants Interval 5.2 to 40.3	9.1 Percentage of participants Interval 2.5 to 21.7	9.1 Percentage of participants Interval 0.2 to 41.3

SECONDARY outcome

Timeframe: Up to approximately 3 years and 1 week

Population: Safety analysis set includes all participants who received at least one dose of study drug; Time to response was summarized for responders (participants who achieved a partial or complete response).

Time to response defined as the time from first study drug administration to the time the response criteria (complete response or partial response) are first met as assessed by the investigator using Lugano criteria with LYRIC modification for cohorts 1 and 2 and ISCL/EORTC guidelines for cohort 3.

Outcome measures

Outcome measures
Measure	Cohort 1: ENKTL n=7 Participants Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)	Cohort 2: PTCL-NOS, AITL, and ALCL n=9 Participants Participants with other R/R mature T-cell neoplasms \[limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)	Cohort 3: MF and SS n=5 Participants Participants with R/R cutaneous T-cell lymphoma \[limited to mycosis fungoides (MF) and Sèzary syndrome (SS)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
Time to Response (TTR)	5.75 Months Interval 2.1 to 13.9	2.86 Months Interval 2.1 to 5.5	6.83 Months Interval 2.6 to 11.1

SECONDARY outcome

Timeframe: Baseline and on Day 1 in Cycles 5, 9, 13, 17, 21, 25, 29, and 33 (21 days per cycle) and safety follow-up visit (up to 30 days after end of treatment; up to approximately 3 years and 1 week)

Population: Safety analysis set includes all participants who received at least one dose of study drug. The number analyzed represents participants who completed the questionnaire.

Mean change from baseline at safety follow-up visit in EQ-5D-5L visual analogue score (VAS). The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' An increasing score indicates improvements from baseline.

Outcome measures

Outcome measures
Measure	Cohort 1: ENKTL n=22 Participants Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)	Cohort 2: PTCL-NOS, AITL, and ALCL n=44 Participants Participants with other R/R mature T-cell neoplasms \[limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)	Cohort 3: MF and SS n=11 Participants Participants with R/R cutaneous T-cell lymphoma \[limited to mycosis fungoides (MF) and Sèzary syndrome (SS)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
Quality of Life Assessment: EQ-5D-5L Change From Baseline in Visual Analogue Score Cycle 21, Day 1	4.25 Score on a scale Standard Deviation 10.905	8.33 Score on a scale Standard Deviation 22.546	5.50 Score on a scale Standard Deviation 18.285
Quality of Life Assessment: EQ-5D-5L Change From Baseline in Visual Analogue Score Cycle 5, Day 1	4.42 Score on a scale Standard Deviation 10.273	1.11 Score on a scale Standard Deviation 13.884	0.25 Score on a scale Standard Deviation 22.276
Quality of Life Assessment: EQ-5D-5L Change From Baseline in Visual Analogue Score Cycle 9, Day 1	1.17 Score on a scale Standard Deviation 4.916	5.56 Score on a scale Standard Deviation 21.279	-0.83 Score on a scale Standard Deviation 17.713
Quality of Life Assessment: EQ-5D-5L Change From Baseline in Visual Analogue Score Cycle 13, Day 1	-3.29 Score on a scale Standard Deviation 16.650	15.00 Score on a scale Standard Deviation 19.685	1.33 Score on a scale Standard Deviation 21.398
Quality of Life Assessment: EQ-5D-5L Change From Baseline in Visual Analogue Score Cycle 17, Day 1	0.17 Score on a scale Standard Deviation 9.326	10.00 Score on a scale Standard Deviation 17.889	3.67 Score on a scale Standard Deviation 23.551
Quality of Life Assessment: EQ-5D-5L Change From Baseline in Visual Analogue Score Cycle 25, Day 1	4.00 Score on a scale Standard Deviation 14.422	-2.50 Score on a scale Standard Deviation 10.607	5.00 Score on a scale Standard Deviation 7.071
Quality of Life Assessment: EQ-5D-5L Change From Baseline in Visual Analogue Score Cycle 29, Day 1	-2.67 Score on a scale Standard Deviation 4.619	-5.00 Score on a scale Standard Deviation 7.071	—
Quality of Life Assessment: EQ-5D-5L Change From Baseline in Visual Analogue Score Cycle 33, Day 1	-3.00 Score on a scale Standard Deviation NA Not estimable due to sample size	0.00 Score on a scale Standard Deviation NA Not estimable due to sample size	—
Quality of Life Assessment: EQ-5D-5L Change From Baseline in Visual Analogue Score Safety Follow-up	-1.50 Score on a scale Standard Deviation 8.546	-9.52 Score on a scale Standard Deviation 21.047	12.50 Score on a scale Standard Deviation 3.536

SECONDARY outcome

Population: Safety analysis set includes all participants who received at least one dose of study drug. The number analyzed represents participants who completed the questionnaire.

Mean change from baseline at safety follow-up visit in EORTC QLQ-C30 Global Health Status/Quality of Life score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer patients and includes global health status and quality of life questions related to their overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Answers are converted to a score of 0 to 100, with a higher score indicating improved health status.

Outcome measures

Outcome measures
Measure	Cohort 1: ENKTL n=22 Participants Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)	Cohort 2: PTCL-NOS, AITL, and ALCL n=44 Participants Participants with other R/R mature T-cell neoplasms \[limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)	Cohort 3: MF and SS n=11 Participants Participants with R/R cutaneous T-cell lymphoma \[limited to mycosis fungoides (MF) and Sèzary syndrome (SS)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Global Health Status Score Cycle 25, Day 1	14.58 Score on a scale Standard Deviation 25.797	-8.33 Score on a scale Standard Deviation 11.785	-4.17 Score on a scale Standard Deviation 5.893
Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Global Health Status Score Cycle 5, Day 1	7.64 Score on a scale Standard Deviation 24.220	6.67 Score on a scale Standard Deviation 19.041	10.42 Score on a scale Standard Deviation 24.296
Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Global Health Status Score Cycle 9, Day 1	8.33 Score on a scale Standard Deviation 10.541	12.04 Score on a scale Standard Deviation 28.294	1.39 Score on a scale Standard Deviation 21.995
Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Global Health Status Score Cycle 13, Day 1	4.76 Score on a scale Standard Deviation 11.644	-1.67 Score on a scale Standard Deviation 19.003	2.78 Score on a scale Standard Deviation 15.516
Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Global Health Status Score Cycle 17, Day 1	2.78 Score on a scale Standard Deviation 12.546	6.94 Score on a scale Standard Deviation 30.008	4.17 Score on a scale Standard Deviation 21.570
Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Global Health Status Score Cycle 21, Day 1	12.50 Score on a scale Standard Deviation 14.434	0.00 Score on a scale Standard Deviation 33.333	0.00 Score on a scale Standard Deviation 20.412
Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Global Health Status Score Cycle 29, Day 1	16.67 Score on a scale Standard Deviation 16.667	-8.33 Score on a scale Standard Deviation 11.785	—
Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Global Health Status Score Cycle 33, Day 1	0.00 Score on a scale Standard Deviation NA Not estimable due to sample size	0.00 Score on a scale Standard Deviation NA Not estimable due to sample size	—
Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Global Health Status Score Safety Follow-up	7.74 Score on a scale Standard Deviation 27.045	-14.93 Score on a scale Standard Deviation 26.917	20.83 Score on a scale Standard Deviation 17.678

SECONDARY outcome

Population: Safety analysis set includes all participants who received at least one dose of study drug. The number analyzed represents participants who completed the questionnaire.

Mean change from baseline at safety follow-up visit in EORTC QLQ-C30 Fatigue score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer patients and includes questions related to fatigue symptoms in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Answers are converted to a score of 0 to 100, with a higher score indicating improved health status.

Outcome measures

Outcome measures
Measure	Cohort 1: ENKTL n=22 Participants Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)	Cohort 2: PTCL-NOS, AITL, and ALCL n=44 Participants Participants with other R/R mature T-cell neoplasms \[limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)	Cohort 3: MF and SS n=11 Participants Participants with R/R cutaneous T-cell lymphoma \[limited to mycosis fungoides (MF) and Sèzary syndrome (SS)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Fatigue Score Cycle 5, Day 1	-2.78 Score on a scale Standard Deviation 14.312	7.02 Score on a scale Standard Deviation 14.912	1.39 Score on a scale Standard Deviation 41.335
Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Fatigue Score Cycle 9, Day 1	0.00 Score on a scale Standard Deviation 12.172	-1.39 Score on a scale Standard Deviation 11.011	-22.22 Score on a scale Standard Deviation 41.574
Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Fatigue Score Cycle 13, Day 1	-1.59 Score on a scale Standard Deviation 11.878	-6.67 Score on a scale Standard Deviation 12.669	-5.56 Score on a scale Standard Deviation 18.257
Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Fatigue Score Cycle 17, Day 1	9.26 Score on a scale Standard Deviation 16.355	1.85 Score on a scale Standard Deviation 10.924	-12.96 Score on a scale Standard Deviation 16.355
Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Fatigue Score Cycle 21, Day 1	0.00 Score on a scale Standard Deviation 12.830	11.11 Score on a scale Standard Deviation 11.111	-16.67 Score on a scale Standard Deviation 14.344
Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Fatigue Score Cycle 25, Day 1	0.00 Score on a scale Standard Deviation 15.713	27.78 Score on a scale Standard Deviation 7.857	-5.56 Score on a scale Standard Deviation 7.857
Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Fatigue Score Cycle 29, Day 1	3.70 Score on a scale Standard Deviation 27.962	22.22 Score on a scale Standard Deviation 15.713	—
Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Fatigue Score Cycle 33, Day 1	11.11 Score on a scale Standard Deviation NA Not estimable due to sample size	33.33 Score on a scale Standard Deviation NA Not estimable due to sample size	—
Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Fatigue Score Safety Follow-up	-1.59 Score on a scale Standard Deviation 19.903	7.87 Score on a scale Standard Deviation 30.820	-44.44 Score on a scale Standard Deviation 31.427

SECONDARY outcome

Timeframe: Up to approximately 3 years and 1 week

Population: Safety analysis set includes all participants who received at least one dose of study drug

Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including clinically relevant changes in laboratory tests, physical examination, electrocardiogram, and vital signs

Outcome measures

Outcome measures
Measure	Cohort 1: ENKTL n=22 Participants Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)	Cohort 2: PTCL-NOS, AITL, and ALCL n=44 Participants Participants with other R/R mature T-cell neoplasms \[limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)	Cohort 3: MF and SS n=11 Participants Participants with R/R cutaneous T-cell lymphoma \[limited to mycosis fungoides (MF) and Sèzary syndrome (SS)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
Number of Participants With Adverse Events At least one TEAE	22 Participants	41 Participants	10 Participants
Number of Participants With Adverse Events SAEs	9 Participants	21 Participants	5 Participants

Adverse Events

Cohort 1: ENKTL

Serious events: 9 serious events

Other events: 21 other events

Deaths: 11 deaths

Cohort 2: PTCL-NOS, AITL, and ALCL

Serious events: 21 serious events

Other events: 39 other events

Deaths: 26 deaths

Cohort 3: MF and SS

Serious events: 5 serious events

Other events: 10 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

BeiGene

Phone: +1-877-828-5568

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information \& may request a further delay to protect its IP rights.
Publication restrictions are in place

Restriction type: OTHER