BeiGene Announces Phase 1b Clinical Results of Zanubrutinib in Combination with GAZYVA® (Obinutuzumab) in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Follicular Lymphoma at the 15th International Conference on Malignant Lympho
“These updated data provide further evidence for the rational combination of zanubrutinib and obinutuzumab, and build upon the foundation supporting our global pivotal Phase 2 trial comparing obinutuzumab plus zanubrutinib to obinutuzumab alone as a treatment for patients with R/R follicular lymphoma. It is our hope that we will continue to see deep and durable responses for these patients,” said
“These data demonstrated that zanubrutinib, in combination with the anti-CD20 monoclonal antibody obinutuzumab was generally well-tolerated, with the majority of adverse events being grade 1 or 2. In addition, the early finding of peripheral blood MRD negativity in three out of six patients with CLL/SLL merits further investigation,” commented
Summary of Updated Clinical Results from the Phase 1b Combination Trial with Obinutuzumab in Patients with TN or R/R CLL/SLL and R/R FL
The open-label, Phase 1b trial (clinicaltrials.gov identifier: NCT02569476) of zanubrutinib in combination with obinutuzumab in patients with B-cell malignancies is being conducted in
As of the data cutoff, 51 patients (62.9%) remained on study treatment, including 33 patients (73.3%) with CLL/SLL and 18 patients (50%) with FL. The median follow-up time for patients with CLL/SLL was 28.9 months (7.9-36.9) and 20.1 months (2.3-37.2) for patients with FL. Results included:
- Of the 20 patients with TN CLL/SLL, the ORR was 100%; the complete response (CR) rate was 30.0% (6/20); and the partial response (PR) rate was 70.0% (14/20). Median follow-up for these patients was 28.8 months (13.9-34.8);
- Of the 25 patients with R/R CLL/SLL, the ORR was 92.0% (23/25); the CR was 28.0% (7/25); and the PR was 64.0% (16/25). Median follow-up for these patients was 28.9 months (7.9-36.9);
- Of the six patients with CLL/SLL who achieved CR and were tested, three were observed to be MRD negative in the peripheral blood.
- Of the 36 patients with R/R FL, the ORR was 72.2% (26/36); the CR was 38.9% (14/36); and the PR was 33.3% (12/36). Median response follow-up was 20.1 months (2.3-37.2);
- For patients with TN or R/R CLL/SLL the median progression free survival (PFS) had not been reached, with 73.3% of patients remaining on treatment. For patients with R/R FL, the median PFS was 24.9 months (0.7-36.4), with 50% of patients remaining on treatment;
- The majority of treatment-emergent adverse events (TEAEs) were grade 1 or 2 in severity;
- The most common TEAEs in patients with CLL/SLL were upper respiratory tract infection (URTI, 51.2%), neutropenia (44.4%), contusion (33.3%), fatigue (26.7%), and diarrhea (26.7%). The most common adverse events (AEs) in patients with FL were URTI (38.9%), contusion (27.8%), fatigue (25.0%), cough (22.2%), and thrombocytopenia (19.5%);
- The most common grade ≥3 AEs in patients with CLL/SLL were neutropenia (31.1%), pneumonia (8.9%), and thrombocytopenia (6.7%). The most common grade ≥3 AEs in patients with FL were neutropenia (13.9%), thrombocytopenia (5.6%), and back pain (2.8%); and
- One patient with CLL/SLL had a TEAE leading to death (metastatic squamous cell carcinoma).
Zanubrutinib (BGB-3111) is an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by
Clinical trials of zanubrutinib include a fully-enrolled, global Phase 3 clinical trial in patients with Waldenström macroglobulinemia (WM) comparing zanubrutinib to ibrutinib, currently the only approved BTK inhibitor for WM; a global Phase 3 clinical trial in patients with previously untreated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL); a pivotal Phase 2 trial in patients with relapsed/refractory (R/R) follicular lymphoma in combination with GAZYVA® (obinutuzumab); a Phase 3 trial comparing zanubrutinib to ibrutinib in patients with R/R CLL/SLL; and a global Phase 1 trial. In
Zanubrutinib has been granted by the
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the encouraging clinical data from clinical trials of zanubrutinib, and BeiGene’s advancement of, and anticipated clinical development, regulatory milestones and commercialization of zanubrutinib. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including
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Source: BeiGene, LTD.