BeiGene Announces Positive Results From Phase 3 SEQUOIA Trial Of Brukinsa In Combo With Bendamustine And Rituximab To Treat CLL Or SLL

BeiGene 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-naïve (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 trial 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-naïve 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.”SEQUOIA is a randomized, multicenter, global phase 3 trial 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.Patients with del(17p) were not randomized to B+R, as they experience poor clinical outcomes and poor response to chemoimmunotherapy. The primary endpoint of the trial is IRC-assessed PFS. Secondary endpoints include investigator-assessed PFS, IRC- and investigator-assessed overall response rate (ORR), overall survival (OS), PFS and ORR in patients with del(17p), and safety.Cohort 2, representing high-risk patients treated with BRUKINSA monotherapy, was previously presented at the American Society for Hematology (ASH) Annual Meeting in December 2020. This cohort of patients with del(17p) achieved significant efficacy with an 18-month PFS of 90.6%, as assessed by investigator.Brukinsa is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies.

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