Adult Nasal Type Extranodal NK/T-cell Lymphoma, ALK-negative Anaplastic Large Cell Lymphoma, ALK-Positive Anaplastic Large Cell Lymphoma, Anaplastic Large Cell Lymphoma, Anaplastic Large Cell Lymphoma, ALK-negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Angioimmunoblastic T-cell Lymphoma, Angioimmunoblastic T-Cell Lymphoma Recurrent, Angioimmunoblastic T-Cell Lymphoma Refractory, Cutaneous T-cell Lymphoma, Extranodal NK/T-cell Lymphoma, Extranodal NK T Cell Lymphoma, Extranodal NK T Cell Lymphoma, Nasal, Extranodal NK/T-cell Lymphoma, Nasal Type, Peripheral T Cell Lymphoma, Peripheral T-cell Lymphoma NOS, Peripheral T-Cell Lymphoma, Not Otherwise Specified, Peripheral T-Cell Lymphoma Refractory, PTCL
Conditions
Keywords
T/NK-cell, NK/T-cell, extranodal, nasal, NK-cell, ENKTL, peripheral T-cell, anaplastic large cell, ALCL, angioimmunoblastic, PTCL-NOS, Relapsed, Refractory
Brief summary
This was a multi-center, prospective, non-randomized, open-label, Phase 2 clinical study to evaluate the safety and efficacy of BGB-A317 in participants with relapsed or refractory mature T- and natural killer (NK)-cell neoplasms. There were three cohorts: * Cohort 1: Relapsed or refractory (R/R) extranodal NK/T cell lymphoma (ENKTL; nasal or non-nasal type) * Cohort 2: Other R/R mature T-cell neoplasms, limited to the following histologies: peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), or anaplastic large-cell lymphoma (ALCL) * Cohort 3: R/R cutaneous T-cell lymphoma, limited to mycosis fungoides (MF) or Sèzary syndrome (SS) Study procedures included a Screening phase (up to 35 days); Treatment phase (until disease progression, intolerable toxicity, or withdrawal of informed consent, whichever occurs first); Safety Follow-up phase (up to 90 days following last study treatment for all adverse events (AEs) and serious adverse events (SAEs)); and Survival follow-up phase (duration varying by participant).
Interventions
DRUGTislelizumab
Administered intravenously
Sponsors
BeiGene
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria * Confirmed diagnosis of relapsed or refractory extranodal NK/T-cell lymphoma (nasal or non-nasal type, peripheral T-cell lymphoma - not otherwise specified, angioimmunoblastic T-cell lymphoma, anaplastic large cell lymphoma, mycosis fungoides, or Sezary syndrome) * Age 18 years or older * Relapsed or refractory to at least 1 prior systemic therapy * Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI) for participants in Cohort 1 and 2 * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 * Life expectancy ≥ 6 months * Adequate respiratory function * Adequate bone marrow function * Adequate renal and hepatic function Key
Exclusion criteria
* Known central nervous system (CNS) involvement by lymphoma * Previously received immune checkpoint therapy * Prior malignancy within the past 3 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 or lower prostate cancer * Active autoimmune disease or history of autoimmune diseases that may relapse with some exceptions * Severe or debilitating pulmonary disease * Clinically significant cardiovascular disease * Active fungal, bacterial, and/or viral infection requiring systemic therapy * Known infection with HIV or active viral hepatitis B or C infection * Major surgery within 4 weeks of the first dose of study drug * Pregnant or lactating women * Vaccination with a live vaccine within 35 days prior to the first dose of study drug * Hypersensitivity to tislelizumab * Concurrent participation in another therapeutic clinical trial NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | Up to approximately 3 years and 1 week | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) | Up to approximately 3 years and 1 week | 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. |
| Overall Survival (OS) | Up to approximately 3 years and 1 week | OS defined as the time from first study drug administration to the date of death due to any reason for cohorts 1 and 2. |
| Complete Response Rate (CRR) | Up to approximately 3 years and 1 week | 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. |
| Time to Response (TTR) | Up to approximately 3 years and 1 week | 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. |
| Duration of Response (DOR) | Up to approximately 3 years and 1 week | 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. |
| Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Global Health Status Score | 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) | 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. |
| Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Fatigue Score | 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) | 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. |
| Number of Participants With Adverse Events | Up to approximately 3 years and 1 week | 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 |
| Quality of Life Assessment: EQ-5D-5L Change From Baseline in Visual Analogue Score | 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) | 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. |
Countries
Canada, China, France, Italy, Taiwan
Participant flow
Recruitment details
Participants were enrolled from study centers in Canada, China, France, Italy, and Taiwan, China.
Participants by arm
| Arm | Count |
|---|---|
| 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) | 22 |
| 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) | 44 |
| 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) | 11 |
| Total | 77 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 11 | 26 | 3 |
| Overall Study | Lost to Follow-up | 1 | 4 | 1 |
| Overall Study | Progressive Disease | 1 | 0 | 0 |
| Overall Study | Transferred to long term extension study | 8 | 13 | 5 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 2 |
Baseline characteristics
| Characteristic | Cohort 1: ENKTL | Cohort 2: PTCL-NOS, AITL, and ALCL | Cohort 3: MF and SS | Total |
|---|---|---|---|---|
| Age, Continuous | 51.5 Years STANDARD_DEVIATION 16.24 | 55.8 Years STANDARD_DEVIATION 15.03 | 59.4 Years STANDARD_DEVIATION 12.45 | 55.1 Years STANDARD_DEVIATION 15.09 |
| Race/Ethnicity, Customized Asian | 19 Participants | 23 Participants | 2 Participants | 44 Participants |
| Race/Ethnicity, Customized Not Reported | 1 Participants | 3 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized White | 2 Participants | 18 Participants | 8 Participants | 28 Participants |
| Region of Enrollment Canada | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Region of Enrollment China | 19 Participants | 22 Participants | 0 Participants | 41 Participants |
| Region of Enrollment France | 1 Participants | 3 Participants | 1 Participants | 5 Participants |
| Region of Enrollment Italy | 2 Participants | 18 Participants | 8 Participants | 28 Participants |
| Region of Enrollment Taiwan | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 8 Participants | 15 Participants | 3 Participants | 26 Participants |
| Sex: Female, Male Male | 14 Participants | 29 Participants | 8 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 11 / 22 | 26 / 44 | 3 / 11 |
| other Total, other adverse events | 21 / 22 | 39 / 44 | 10 / 11 |
| serious Total, serious adverse events | 9 / 22 | 21 / 44 | 5 / 11 |
Outcome results
Primary
Overall Response Rate (ORR)
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.
Time frame: Up to approximately 3 years and 1 week
Population: Safety analysis set includes all participants who received at least one dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: ENKTL | Overall Response Rate (ORR) | 31.8 Percentage of participants |
| Cohort 2: PTCL-NOS, AITL, and ALCL | Overall Response Rate (ORR) | 20.5 Percentage of participants |
| Cohort 3: MF and SS | Overall Response Rate (ORR) | 45.5 Percentage of participants |
Secondary
Complete Response Rate (CRR)
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.
Time frame: Up to approximately 3 years and 1 week
Population: Safety analysis set includes all participants who received at least one dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: ENKTL | Complete Response Rate (CRR) | 18.2 Percentage of participants |
| Cohort 2: PTCL-NOS, AITL, and ALCL | Complete Response Rate (CRR) | 9.1 Percentage of participants |
| Cohort 3: MF and SS | Complete Response Rate (CRR) | 9.1 Percentage of participants |
Secondary
Duration of Response (DOR)
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.
Time frame: 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).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: ENKTL | Duration of Response (DOR) | NA Months |
| Cohort 2: PTCL-NOS, AITL, and ALCL | Duration of Response (DOR) | 8.2 Months |
| Cohort 3: MF and SS | Duration of Response (DOR) | 11.3 Months |
Secondary
Number of Participants With Adverse Events
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
Time frame: Up to approximately 3 years and 1 week
Population: Safety analysis set includes all participants who received at least one dose of study drug
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: ENKTL | Number of Participants With Adverse Events | At least one TEAE | 22 Participants |
| Cohort 1: ENKTL | Number of Participants With Adverse Events | SAEs | 9 Participants |
| Cohort 2: PTCL-NOS, AITL, and ALCL | Number of Participants With Adverse Events | At least one TEAE | 41 Participants |
| Cohort 2: PTCL-NOS, AITL, and ALCL | Number of Participants With Adverse Events | SAEs | 21 Participants |
| Cohort 3: MF and SS | Number of Participants With Adverse Events | At least one TEAE | 10 Participants |
| Cohort 3: MF and SS | Number of Participants With Adverse Events | SAEs | 5 Participants |
Secondary
Overall Survival (OS)
OS defined as the time from first study drug administration to the date of death due to any reason for cohorts 1 and 2.
Time frame: Up to approximately 3 years and 1 week
Population: Safety analysis set includes all participants who received at least one dose of study drug
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: ENKTL | Overall Survival (OS) | 8.8 Months |
| Cohort 2: PTCL-NOS, AITL, and ALCL | Overall Survival (OS) | 13.3 Months |
Secondary
Progression-free Survival (PFS)
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.
Time frame: Up to approximately 3 years and 1 week
Population: Safety analysis set includes all participants who received at least one dose of study drug
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: ENKTL | Progression-free Survival (PFS) | 2.7 Months |
| Cohort 2: PTCL-NOS, AITL, and ALCL | Progression-free Survival (PFS) | 2.7 Months |
| Cohort 3: MF and SS | Progression-free Survival (PFS) | 16.8 Months |
Secondary
Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Fatigue Score
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: ENKTL | 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 |
| Cohort 1: ENKTL | 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 |
| Cohort 1: ENKTL | 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 |
| Cohort 1: ENKTL | 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 |
| Cohort 1: ENKTL | 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 |
| Cohort 1: ENKTL | 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 12.83 |
| Cohort 1: ENKTL | 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 |
| Cohort 1: ENKTL | 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 |
| Cohort 1: ENKTL | Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Fatigue Score | Cycle 33, Day 1 | 11.11 Score on a scale | — |
| Cohort 2: PTCL-NOS, AITL, and ALCL | Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Fatigue Score | Cycle 33, Day 1 | 33.33 Score on a scale | — |
| Cohort 2: PTCL-NOS, AITL, and ALCL | Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Fatigue Score | Cycle 29, Day 1 | 22.22 Score on a scale | Standard Deviation 15.713 |
| Cohort 2: PTCL-NOS, AITL, and ALCL | Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Fatigue Score | Safety Follow-up | 7.87 Score on a scale | Standard Deviation 30.82 |
| Cohort 2: PTCL-NOS, AITL, and ALCL | Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Fatigue Score | Cycle 5, Day 1 | 7.02 Score on a scale | Standard Deviation 14.912 |
| Cohort 2: PTCL-NOS, AITL, and ALCL | Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Fatigue Score | Cycle 13, Day 1 | -6.67 Score on a scale | Standard Deviation 12.669 |
| Cohort 2: PTCL-NOS, AITL, and ALCL | Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Fatigue Score | Cycle 17, Day 1 | 1.85 Score on a scale | Standard Deviation 10.924 |
| Cohort 2: PTCL-NOS, AITL, and ALCL | Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Fatigue Score | Cycle 21, Day 1 | 11.11 Score on a scale | Standard Deviation 11.111 |
| Cohort 2: PTCL-NOS, AITL, and ALCL | Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Fatigue Score | Cycle 25, Day 1 | 27.78 Score on a scale | Standard Deviation 7.857 |
| Cohort 2: PTCL-NOS, AITL, and ALCL | Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Fatigue Score | Cycle 9, Day 1 | -1.39 Score on a scale | Standard Deviation 11.011 |
| Cohort 3: MF and SS | Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Fatigue Score | Cycle 25, Day 1 | -5.56 Score on a scale | Standard Deviation 7.857 |
| Cohort 3: MF and SS | Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Fatigue Score | Cycle 21, Day 1 | -16.67 Score on a scale | Standard Deviation 14.344 |
| Cohort 3: MF and SS | Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Fatigue Score | Cycle 5, Day 1 | 1.39 Score on a scale | Standard Deviation 41.335 |
| Cohort 3: MF and SS | Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Fatigue Score | Cycle 13, Day 1 | -5.56 Score on a scale | Standard Deviation 18.257 |
| Cohort 3: MF and SS | Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Fatigue Score | Cycle 9, Day 1 | -22.22 Score on a scale | Standard Deviation 41.574 |
| Cohort 3: MF and SS | Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Fatigue Score | Safety Follow-up | -44.44 Score on a scale | Standard Deviation 31.427 |
| Cohort 3: MF and SS | Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Fatigue Score | Cycle 17, Day 1 | -12.96 Score on a scale | Standard Deviation 16.355 |
Secondary
Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Global Health Status Score
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: ENKTL | 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 |
| Cohort 1: ENKTL | 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 | — |
| Cohort 1: ENKTL | 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 |
| Cohort 1: ENKTL | 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 24.22 |
| Cohort 1: ENKTL | 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 |
| Cohort 1: ENKTL | 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 |
| Cohort 1: ENKTL | 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 |
| Cohort 1: ENKTL | 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 |
| Cohort 1: ENKTL | 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 |
| Cohort 2: PTCL-NOS, AITL, and ALCL | Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Global Health Status Score | Cycle 13, Day 1 | -1.67 Score on a scale | Standard Deviation 19.003 |
| Cohort 2: PTCL-NOS, AITL, and ALCL | Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Global Health Status Score | Cycle 29, Day 1 | -8.33 Score on a scale | Standard Deviation 11.785 |
| Cohort 2: PTCL-NOS, AITL, and ALCL | Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Global Health Status Score | Cycle 5, Day 1 | 6.67 Score on a scale | Standard Deviation 19.041 |
| Cohort 2: PTCL-NOS, AITL, and ALCL | 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 | — |
| Cohort 2: PTCL-NOS, AITL, and ALCL | Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Global Health Status Score | Cycle 25, Day 1 | -8.33 Score on a scale | Standard Deviation 11.785 |
| Cohort 2: PTCL-NOS, AITL, and ALCL | Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Global Health Status Score | Safety Follow-up | -14.93 Score on a scale | Standard Deviation 26.917 |
| Cohort 2: PTCL-NOS, AITL, and ALCL | Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Global Health Status Score | Cycle 9, Day 1 | 12.04 Score on a scale | Standard Deviation 28.294 |
| Cohort 2: PTCL-NOS, AITL, and ALCL | Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Global Health Status Score | Cycle 17, Day 1 | 6.94 Score on a scale | Standard Deviation 30.008 |
| Cohort 2: PTCL-NOS, AITL, and ALCL | Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Global Health Status Score | Cycle 21, Day 1 | 0.00 Score on a scale | Standard Deviation 33.333 |
| Cohort 3: MF and SS | Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Global Health Status Score | Safety Follow-up | 20.83 Score on a scale | Standard Deviation 17.678 |
| Cohort 3: MF and SS | Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Global Health Status Score | Cycle 5, Day 1 | 10.42 Score on a scale | Standard Deviation 24.296 |
| Cohort 3: MF and SS | Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Global Health Status Score | Cycle 9, Day 1 | 1.39 Score on a scale | Standard Deviation 21.995 |
| Cohort 3: MF and SS | Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Global Health Status Score | Cycle 13, Day 1 | 2.78 Score on a scale | Standard Deviation 15.516 |
| Cohort 3: MF and SS | Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Global Health Status Score | Cycle 17, Day 1 | 4.17 Score on a scale | Standard Deviation 21.57 |
| Cohort 3: MF and SS | Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Global Health Status Score | Cycle 25, Day 1 | -4.17 Score on a scale | Standard Deviation 5.893 |
| Cohort 3: MF and SS | Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Global Health Status Score | Cycle 21, Day 1 | 0.00 Score on a scale | Standard Deviation 20.412 |
Secondary
Quality of Life Assessment: EQ-5D-5L Change From Baseline in Visual Analogue Score
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: ENKTL | Quality of Life Assessment: EQ-5D-5L Change From Baseline in Visual Analogue Score | Cycle 33, Day 1 | -3.00 Score on a scale | — |
| Cohort 1: ENKTL | 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 |
| Cohort 1: ENKTL | 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 16.65 |
| Cohort 1: ENKTL | 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 |
| Cohort 1: ENKTL | 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 |
| Cohort 1: ENKTL | 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 |
| Cohort 1: ENKTL | 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 |
| Cohort 1: ENKTL | 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 |
| Cohort 1: ENKTL | 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 |
| Cohort 2: PTCL-NOS, AITL, and ALCL | Quality of Life Assessment: EQ-5D-5L Change From Baseline in Visual Analogue Score | Cycle 9, Day 1 | 5.56 Score on a scale | Standard Deviation 21.279 |
| Cohort 2: PTCL-NOS, AITL, and ALCL | Quality of Life Assessment: EQ-5D-5L Change From Baseline in Visual Analogue Score | Cycle 25, Day 1 | -2.50 Score on a scale | Standard Deviation 10.607 |
| Cohort 2: PTCL-NOS, AITL, and ALCL | Quality of Life Assessment: EQ-5D-5L Change From Baseline in Visual Analogue Score | Cycle 33, Day 1 | 0.00 Score on a scale | — |
| Cohort 2: PTCL-NOS, AITL, and ALCL | Quality of Life Assessment: EQ-5D-5L Change From Baseline in Visual Analogue Score | Safety Follow-up | -9.52 Score on a scale | Standard Deviation 21.047 |
| Cohort 2: PTCL-NOS, AITL, and ALCL | Quality of Life Assessment: EQ-5D-5L Change From Baseline in Visual Analogue Score | Cycle 5, Day 1 | 1.11 Score on a scale | Standard Deviation 13.884 |
| Cohort 2: PTCL-NOS, AITL, and ALCL | Quality of Life Assessment: EQ-5D-5L Change From Baseline in Visual Analogue Score | Cycle 21, Day 1 | 8.33 Score on a scale | Standard Deviation 22.546 |
| Cohort 2: PTCL-NOS, AITL, and ALCL | Quality of Life Assessment: EQ-5D-5L Change From Baseline in Visual Analogue Score | Cycle 13, Day 1 | 15.00 Score on a scale | Standard Deviation 19.685 |
| Cohort 2: PTCL-NOS, AITL, and ALCL | Quality of Life Assessment: EQ-5D-5L Change From Baseline in Visual Analogue Score | Cycle 29, Day 1 | -5.00 Score on a scale | Standard Deviation 7.071 |
| Cohort 2: PTCL-NOS, AITL, and ALCL | Quality of Life Assessment: EQ-5D-5L Change From Baseline in Visual Analogue Score | Cycle 17, Day 1 | 10.00 Score on a scale | Standard Deviation 17.889 |
| Cohort 3: MF and SS | Quality of Life Assessment: EQ-5D-5L Change From Baseline in Visual Analogue Score | Safety Follow-up | 12.50 Score on a scale | Standard Deviation 3.536 |
| Cohort 3: MF and SS | Quality of Life Assessment: EQ-5D-5L Change From Baseline in Visual Analogue Score | Cycle 25, Day 1 | 5.00 Score on a scale | Standard Deviation 7.071 |
| Cohort 3: MF and SS | Quality of Life Assessment: EQ-5D-5L Change From Baseline in Visual Analogue Score | Cycle 5, Day 1 | 0.25 Score on a scale | Standard Deviation 22.276 |
| Cohort 3: MF and SS | Quality of Life Assessment: EQ-5D-5L Change From Baseline in Visual Analogue Score | Cycle 9, Day 1 | -0.83 Score on a scale | Standard Deviation 17.713 |
| Cohort 3: MF and SS | Quality of Life Assessment: EQ-5D-5L Change From Baseline in Visual Analogue Score | Cycle 13, Day 1 | 1.33 Score on a scale | Standard Deviation 21.398 |
| Cohort 3: MF and SS | Quality of Life Assessment: EQ-5D-5L Change From Baseline in Visual Analogue Score | Cycle 17, Day 1 | 3.67 Score on a scale | Standard Deviation 23.551 |
| Cohort 3: MF and SS | Quality of Life Assessment: EQ-5D-5L Change From Baseline in Visual Analogue Score | Cycle 21, Day 1 | 5.50 Score on a scale | Standard Deviation 18.285 |
Secondary
Time to Response (TTR)
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.
Time frame: 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).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: ENKTL | Time to Response (TTR) | 5.75 Months |
| Cohort 2: PTCL-NOS, AITL, and ALCL | Time to Response (TTR) | 2.86 Months |
| Cohort 3: MF and SS | Time to Response (TTR) | 6.83 Months |