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

A Phase 2, Open-Label Study of BGB-A317 in Patients With Relapsed or Refractory Mature T- and NK-cell Neoplasms

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).

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.