CAMBRIDGE, Mass. & BEIJING– BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, today announced that BRUKINSA® (zanubrutinib) has been approved by Health Canada for the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy. This is the second approval for BRUKINSA in Canada, following its initial approval in March 2021 for adult patients with Waldenström’s macroglobulinemia (WM).
“BRUKINSA was specifically designed by BeiGene scientists to provide deep and durable responses for patients with hematologic malignancies, while also reducing the frequency of certain off-target side effects seen with first-generation BTK inhibitors. Today’s approval in Canada for patients with MCL follows its approval for patients with WM earlier in the year, where Canada was the first country to grant approval for BRUKINSA in patients with WM,” said Jane Huang, M.D., Chief Medical Officer, Hematology, BeiGene. “We are excited to continue working with patients and physicians in Canada, as well as in other markets, as part of our broad clinical development program for BRUKINSA investigating eight indications in over 25 clinical trials, with more than 3,100 patients participating.”
“For many patients treated with previously approved BTK inhibitors for MCL, adequate responses are not achievable, or they can be forced to discontinue treatment early due to side effects. Today, we have a new option for our adult patients in Canada who have received one prior systemic or targeted therapy and are living with MCL, an aggressive blood cancer that is often diagnosed at a more advanced stage,” said John Kuruvilla, M.D., FRCPC, Associate Professor of Medicine at the University of Toronto and Clinical Investigator at the Princess Margaret Cancer Centre in Toronto.
“The approval of BRUKINSA as a second line therapy is positive news for patients undergoing treatment for mantle cell lymphoma,” said Antonella Rizza, Chief Executive Officer at Lymphoma Canada. “Expanded treatment options have the potential to transform the patient experience and provide hope to people living with a mantle cell diagnosis.”
The Health Canada approval for BRUKINSA in MCL is based on efficacy results from two single-arm clinical trials. Across both trials, as assessed by independent review committee (IRC) per 2014 Lugano Classification BRUKINSA achieved an overall response rate (ORR) of 84%, defined as the combined rate of complete responses (CRs) and partial responses (PRs).
In the multicenter Phase 2 trial of zanubrutinib in patients with relapsed or refractory (R/R) MCL BGB-3111-206 (NCT03206970), with a median follow-up time of 18.5 months, the ORR was 84% (95% CI: 74, 91), including 69% CRs (FDG-PET scan required) and 15% PRs; the median duration of response (DoR) was 19.5 months (95% CI: 16.6, NE). In the global Phase 1/2 trial BGB-3111-AU-003 (NCT02343120), with a media follow-up time of 18.8 months, the ORR was 84% (95% CI: 67, 95), including 25% CRs (FDG-PET scan not required) and 59% PRs; the median DoR was 18.5 months (95% CI: 12.6, NE).
Of the 118 patients with MCL who received at least one prior therapy and received BRUKINSA treatment, 13.6% of patients discontinued treatment due to adverse events in the trials, with the most frequent being pneumonia (3.4%). Adverse events leading to dose reduction occurred in 3.4% of patients, including hepatitis B, neutropenia, allergic dermatitis, and peripheral sensory neuropathy (in one patient each).
The overall safety profile of BRUKINSA is based on pooled data from 779 patients with B-cell malignancies treated with BRUKINSA in clinical trials. The most common adverse reactions (≥10%) with BRUKINSA were neutropenia, thrombocytopenia, upper respiratory tract infection, anemia, rash, musculoskeletal pain, diarrhea, cough, contusion, pneumonia (grouped terms), urinary tract infection, hemorrhage (grouped terms), and hematuria. Overall, 18% of patients experienced serious adverse reactions. The most frequent (≥2%) serious adverse reactions were pneumonia (10.0%) and hemorrhage (2.1%).
The recommended dose of BRUKINSA is either 160 mg twice daily or 320 mg once daily, taken orally with or without food. The dose may be adjusted for adverse reactions and reduced for patients with severe hepatic impairment and certain drug interactions.
BRUKINSA is available in Canada for the treatment of MCL and Waldenström’s macroglobulinemia through the myBeiGene® patient support program, established to support patients, caregivers, and health care providers.
