BeiGene Announces Positive Topline Results from Phase 3 SEQUOIA Trial Comparing BRUKINSA (Zanubrutinib) to Bendamustine Plus Rituximab in Patients with Treatment-Naïve Chronic Lymphocytic Leukemia

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-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 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-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.”

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.

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.