Phase 2
Completed N=217
A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma
Source: ClinicalTrials.gov NCT03332017 ↗Enrolled (actual)
217
Serious AEs
46.8%
Results posted
Apr 2024
Primary outcomePrimary: Overall Response Rate (ORR) by Independent Central Review (ICR) Assessment — 45.8; 68.3 percentage of participants — p=0.0017
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR) by Independent Central Review (ICR) Assessment |
45.8; 68.3 | 0.0017 sig |
| SECONDARY Overall Response Rate (ORR) as Assessed by the Investigator |
41.7; 66.2 | 0.0006 sig |
| SECONDARY Duration of Response (DOR) as Determined by Investigator Assessment |
9.2; 30.6 | — |
| SECONDARY DOR as Determined by ICR |
NA; NA | — |
| SECONDARY Progression-free Survival (PFS) |
11.2; 27.4; 5.8; 22.2 | 0.0001 sig |
| SECONDARY Overall Survival (OS) |
NA; NA | 0.0177 sig |
| SECONDARY Complete Response Rate |
19.4; 37.2; 19.4; 29.0 | 0.0083 sig |
| SECONDARY Time to Response (TTR) |
2.83; 2.83; 2.79; 2.79 | — |
| SECONDARY Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL), Physical Functioning, Role Functioning, and Symptom Scores |
-2.222; 4.023; 4.955; 2.577; -1.449; 0.361 | 0.0302 sig |
| SECONDARY Change From Baseline in European Quality of Life 5-Dimensions, 5-level (EQ-5D-5L) Visual Analogue Scale (VAS) |
-0.3; 2.4; 2.0; 3.1 | — |
| SECONDARY Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
65; 137; 22; 75 | — |
| SECONDARY Area Under the Curve (AUCss) of Zanubrutinib at Steady State |
2203.619021 | — |
| SECONDARY Zanubrutinib Plasma Concentrations |
254.30; 22.29; 198.37 | — |
| SECONDARY Minimum Observed Concentration (Cmin) of Zanubrutinib at Steady State |
11.51 | — |
| SECONDARY Maximum Observed Concentration (Cmax) of Zanubrutinib at Steady State |
299.83 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03332017). 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. Informational only — not medical advice.