A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma

An International, Phase 2, Open-Label, Randomized Study of BGB-3111 Combined With Obinutuzumab Compared With Obinutuzumab Monotherapy in Relapsed/ Refractory Follicular Lymphoma

This clinical study examined the safety and efficacy of the combination of zanubrutinib and obinutuzumab versus obinutuzumab alone in adults with follicular lymphoma whose disease returned after or did not respond to prior therapy.

This study randomly assigned participants in a 2:1 ratio to receive either zanubrutinib plus obinutuzumab or obinutuzumab alone. The assignment considered how many prior treatments participants had received, whether their cancer had stopped responding to rituximab, and whether they were enrolled in Mainland China or other regions. Each treatment cycle lasted 28 days, with zanubrutinib taken by mouth twice daily and obinutuzumab given intravenously on a set schedule, followed by optional maintenance for up to 24 months. Participants who had obinutuzumab alone could have switched to the combination treatment if their disease worsened or did not respond after 12 months, if confirmed by an independent review.

Key Inclusion Criteria:

• Participants had a histologically confirmed diagnosis of B-cell follicular lymphoma.
• Participants had received two or more prior systemic treatments for follicular lymphoma.
• Participants had previously received both an anti-cluster of differentiation 20 (anti-CD20) antibody and an appropriate alkylator-based combination therapy.
• Participants had disease that had progressed after completion of the most recent therapy or was considered refractory to treatment.
• Participants had measurable disease present.
• Archival tissue confirming the diagnosis was available.
• Participants had an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
• Participants had adequate renal and hepatic function.

Key Exclusion Criteria:

• Participants had prior exposure to a Bruton's tyrosine kinase (BTK) inhibitor.
• Participants had known central nervous system involvement by leukemia or lymphoma.
• Participants had evidence of transformation from follicular lymphoma to another aggressive histologic subtype.
• Participants had undergone an allogeneic hematopoietic stem cell transplantation within 12 months of enrollment.
• Participants had a prior malignancy within the past 2 years, except for those who had curatively treated basal cell or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized prostate cancer with a Gleason score of 6.
• Participants had clinically significant cardiovascular disease.
• Participants had undergone major surgery within 4 weeks prior to the start of study treatment.
• Participants had an active fungal, bacterial, or viral infection requiring systemic treatment.
• Participants had a history of severe bleeding disorder.

Note: Other protocol-defined inclusion and exclusion criteria may have applied.