BeiGene Announces Positive Topline Results from Phase 3 SEQUOIA Trial Comparing BRUKINSA? (Zanubrutinib) to Bendamustine Plus Rituximab in Patients with Treatment-Na?ve Chronic Lymphocytic Le
Trial met the primary endpoint at interim analysis, with BRUKINSA significantly prolonging progression-free survival compared to chemoimmunotherapy and safety and tolerability consistent with its known profile
SEQUOIA is the second positive global Phase 3 trial of BRUKINSA in chronic lymphocytic leukemia, following ALPINE in relapsed or refractory setting
CAMBRIDGE, Mass.?&?BEIJING, China--(BUSINESS WIRE)--?BeiGene, Ltd.?(NASDAQ: BGNE; HKEX: 06160), a global, science-driven biotechnology company, today announced positive topline results from an interim analysis of the Phase 3 SEQUOIA trial comparing BRUKINSA??(zanubrutinib) to bendamustine and rituximab (B+R) in patients with treatment-na?ve (TN) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) whose tumor did not exhibit the deletion of chromosome 17p13.1 (del[17p]). With a median follow-up of 25.8 months, the SEQUOIA trial met the primary endpoint of progression-free survival (PFS) as assessed by independent review committee (IRC), as BRUKINSA achieved a highly statistically significant improvement in PFS compared to B+R. In addition, the trial demonstrated a statistically significant improvement in PFS per investigator assessment, a secondary endpoint. BRUKINSA was also generally well-tolerated, consistent with its known safety profile. ?The combined clinical evidence from SEQUOIA, ALPINE1, the 205 trial2, and the AU-003 trial3?validates our confidence in BRUKINSA as a regimen which can offer improvements in treatment outcomes for hundreds of thousands of patients living with CLL,? said?Jane Huang, M.D., Chief Medical Officer, Hematology at?BeiGene. ?We are pleased to see that at the interim analysis of the SEQUOIA trial, BRUKINSA significantly prolonged progression-free survival for treatment-na?ve CLL patients, and that the demonstrated safety profile was consistent with what we have observed in its global development program with more than 2,300 patients treated with BRUKINSA to date.? 1. Results from the interim analysis of ALPINE with a median follow-up time of 15.3 months were reported at the 2021?European Hematology Association (EHA2021) Congress?in?June 2021. Available at?EHA Open Access Library. 2. Long-term results from BGB-3111-205 with a median follow-up time of 34 months were reported at the?EHA2021 Congress?in?June 2021. Available at?EHA Open Access Library. 3. Long-term results from BGB-3111-AU-003 in relapsed or refractory CLL with a median follow-up time of 39.4 months were shared at the BeiGene Investor Conference Call in?June 2021. Available?ir.beigene.com. About SEQUOIA SEQUOIA is a randomized, multicenter, global Phase 3 trial (NCT03336333) designed to evaluate the efficacy and safety of BRUKINSA compared to B+R in patients with TN CLL or SLL. The trial consists of three cohorts:- Cohort 1 (n=479): randomized 1:1 to receive BRUKINSA (n=241) or B+R (n=238) until disease progression or unacceptable toxicity, in patients not harboring del(17p); data from this group comprise the primary endpoint;
- Cohort 2 (n=110): patients with del(17p) receiving BRUKINSA as a monotherapy; and
- Cohort 3 (enrollment ongoing): patients with del(17p) or pathogenic TP53 variant receiving BRUKINSA in combination with venetoclax.
- For the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy (United States,?November 2019)*;
- For the treatment of MCL in adult patients who have received at least one prior therapy (China,?June 2020)**;
- For the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adult patients who have received at least one prior therapy (China,?June 2020)**;
- For the treatment of relapsed or refractory MCL (United Arab Emirates,?February 2021);
- For the treatment of Waldenstr?m?s macroglobulinemia (WM) in adult patients (Canada,?March 2021);
- Registered and reimbursed for the treatment of MCL in patients who have received at least one prior therapy (Israel,?April 2021);
- For the treatment of adult patients with WM who have received at least one prior therapy (China,?June 2021)**; and
- For the treatment of MCL in adult patients who have received at least one prior therapy (Canada,?July 2021).
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BeiGene Contacts Investor Contact Gabrielle Zhou +86 10-5895-8058 ir@beigene.com Media Contact Liza Heapes?or?Vivian Ni +1 857-302-5663 or +1 857-302-7596 media@beigene.com Source:?BeiGene, Ltd.