BeiGene Presents Updated Preliminary Phase 1b Data on BTK Inhibitor Zanubrutinib (BGB-3111) Combined with GAZYVA® (Obinutuzumab) at the 59th American Society of Hematology Annual Meeting
Dec 09, 2017 9:00 AM
“These updated Phase 1b data continue to indicate that zanubrutinib in combination with obinutuzumab is well tolerated and highly active in patients with CLL/SLL and FL. Toxicity-related treatment discontinuation has been rare, and the rate and depth of respone in FL, as well as the rate of complete responses in CLL/SLL, is very encouraging,” commented
“We are excited to see the frequency and depth of responses in patients with CLL/SLL and R/R FL from this Phase 1b trial. We believe that these updated preliminary data continue to support our ongoing global pivotal Phase 2 trial of this combination in R/R FL,” commented
Summary of Results from the Ongoing Phase 1b Trial
The open-label, multi-center, Phase 1b trial of zanubrutinib in combination with obinutuzumab in patients with B-cell malignancies is being conducted in
At the time of data cutoff, the most common adverse events (AEs) were grade 1-2. The most common AEs in patients with CLL/SLL (occurring in ≥ 20% of patients) of any attribution were petechiae/purpura/contusion (42%), neutropenia (40%), upper respiratory tract infection (URTI) (36%), fatigue (24%), thrombocytopenia (24%), diarrhea (20%), and pyrexia (20%). The most common AEs in patients with FL (occurring in ≥ 20% of patients) of any attribution were URTI (38%), petechia/purpura/contusion (35%), rash (27%), and thrombocytopenia (23%). Grade 3 or 4 AEs of any attribution reported in ≥ 5% of the CLL/SLL patients included neutropenia (24%) and thrombocytopenia (7%). Grade 3 or 4 AEs of any attribution reported in ≥ 5% of the FL patients included neutropenia (12%). There were no cases of serious hemorrhage (≥ grade 3 hemorrhage or central nervous system hemorrhage of any grade), atrial fibrillation, or grade 3 or above diarrhea. Only one patient with CLL/SLL discontinued treatment due to an AE, a case of squamous cell carcinoma (SCC) in a patient who had a prior history of SCC. This was also the only patient in the study who had a fatal AE.
At the time of data cutoff, 45 patients with CLL/SLL (20 TN and 25 R/R) and 21 patients with R/R FL were evaluable for efficacy. In TN CLL/SLL patients, after a median follow-up of 11.4 months (6.0–17.3 months), the overall response rate (ORR) was 95% with complete responses (CRs) in 35% and partial responses (PRs) in 60% of patients. In R/R CLL/SLL patients, at a median follow-up time of 12.7 months (7.9–19.5 months), the ORR was 92% with CRs in 20% and PRs in 72% of patients. In R/R FL patients, at a median follow-up time of 12.1 months (0.8–19.7 months), the ORR was 76% with CRs in 38% and PRs in 38% of patients. ORR in high-risk CLL/SLL patients with del17p/p53 mutation (n=6), del11q mutation (n=6), and unmutated IGHV (n=19) were 83%, 100%, and 95%, respectively. The majority of patients remained on treatment at the time of data cutoff.
About Zanubrutinib
Zanubrutinib (BGB-3111) is an investigational small molecule inhibitor of BTK that has demonstrated higher selectivity against BTK than ibrutinib (a BTK inhibitor currently approved by the
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Forward-Looking Statements
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 of BGB-3111 and BeiGene’s advancement of, and anticipated clinical development and regulatory milestones and plans related to BGB-3111. 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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