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

BeiGene

Status and phase: Completed; Phase 2

Conditions: ALK-negative Anaplastic Large Cell Lymphoma; Cutaneous T-cell Lymphoma; Anaplastic Large Cell Lymphoma, ALK-Positive; Extranodal NK/T-cell Lymphoma; Peripheral T-Cell Lymphoma Refractory; ALK-Positive Anaplastic Large Cell Lymphoma; Anaplastic Large Cell Lymphoma; PTCL; Angioimmunoblastic T-Cell Lymphoma Recurrent; Anaplastic Large Cell Lymphoma, ALK-negative; Peripheral T-cell Lymphoma NOS; Extranodal NK T Cell Lymphoma; Extranodal NK T Cell Lymphoma, Nasal; Extranodal NK/T-cell Lymphoma, Nasal Type; Angioimmunoblastic T-cell Lymphoma; Adult Nasal Type Extranodal NK/T-cell Lymphoma; Peripheral T Cell Lymphoma; Angioimmunoblastic T-Cell Lymphoma Refractory; Peripheral T-Cell Lymphoma, Not Otherwise Specified

Treatments: Drug: Tislelizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03493451

2017-003700-44 (EudraCT Number)

BGB-A317-207

CTR20171387 (Registry Identifier)

Details and patient eligibility

About

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).

Enrollment: 77 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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77 participants in 3 patient groups

Cohort 1: ENKTL

Experimental group

Description:

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)

Treatment:

Drug: Tislelizumab

Cohort 2: PTCL-NOS, AITL, and ALCL

Experimental group

Description:

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)

Treatment:

Drug: Tislelizumab

Cohort 3: MF and SS

Experimental group

Description:

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)

Treatment:

Drug: Tislelizumab