Phase 2
N=77
Study of BGB-A317 in Participants With Relapsed or Refractory Mature T- and NK-cell Neoplasms
Peripheral T Cell Lymphoma · PTCL · Extranodal NK/T-cell Lymphoma · Extranodal NK/T-cell Lymphoma, Nasal Type · Extranodal NK T Cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT03493451 ↗Enrolled (actual)
77
Serious AEs
45.5%
Results posted
May 2022
Primary outcome: Primary: Overall Response Rate (ORR) — 31.8; 20.5; 45.5 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tislelizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- BeiGene
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR) |
31.8; 20.5; 45.5 | — |
| SECONDARY Duration of Response (DOR) |
NA; 8.2; 11.3 | — |
| SECONDARY Progression-free Survival (PFS) |
2.7; 2.7; 16.8 | — |
| SECONDARY Overall Survival (OS) |
8.8; 13.3 | — |
| SECONDARY Complete Response Rate (CRR) |
18.2; 9.1; 9.1 | — |
| SECONDARY Time to Response (TTR) |
5.75; 2.86; 6.83 | — |
| SECONDARY Quality of Life Assessment: EQ-5D-5L Change From Baseline in Visual Analogue Score |
4.42; 1.11; 0.25; 1.17; 5.56; -0.83 | — |
| SECONDARY Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Global Health Status Score |
7.64; 6.67; 10.42; 8.33; 12.04; 1.39 | — |
| SECONDARY Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Fatigue Score |
-2.78; 7.02; 1.39; 0.00; -1.39; -22.22 | — |
| SECONDARY Number of Participants With Adverse Events |
22; 41; 10; 9; 21; 5 | — |
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).
Eligibility 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/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT03493451). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.