On March 3, 2022 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines, reported that BRUKINSA (zanubrutinib) has been approved by Health Canada for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy (Press release, BeiGene, MAR 3, 2022, View Source [SID1234609486]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We will continue to work with physicians and their patients as part of our broad global clinical program for BRUKINSA, which includes 35 trials and more than 3,900 subjects across 28 markets."
"We are pleased that BRUKINSA is now approved in its third indication in Canada, R/R MZL, and this terrific milestone was made possible by the participating patients and investigators. This approval further supports our belief that BRUKINSA is a potentially best-in-class BTK inhibitor, with the MAGNOLIA trial results in R/R MZL providing additional evidence that the selective design of BRUKINSA can be translated into improved treatment outcomes," said Jane Huang, M.D., Chief Medical Officer of Hematology at BeiGene. "We will continue to work with physicians and their patients as part of our broad global clinical program for BRUKINSA, which includes 35 trials and more than 3,900 subjects across 28 markets."
"BRUKINSA is a highly selective next-generation BTK inhibitor designed to improve tolerability by minimizing off-target binding. In clinical trials, BRUKINSA achieved a high overall response rate among relapsed/refractory MZL patients and was generally well-tolerated. With this approval, Canadian patients with R/R MZL will have the option to receive BRUKINSA monotherapy as a treatment and a new hope for improved treatment outcomes," said Dr. Anthea Peters, a hematologist at the Cross Cancer Institute in Edmonton, Alberta.
"The approval of this medicine for the treatment of R/R MZL represents a new treatment option and is welcome news to Canadians living with this rare type of lymphoma," commented Antonella Rizza, Chief Executive Officer of Lymphoma Canada.
"We are delighted that BRUKINSA is now approved for patients with R/R MZL. Since our first approval 11 months ago, we have been expanding our organization in Canada and working to deliver on our commitment to create access to BRUKINSA for patients living with MCL, WM, and now MZL," added Peter Brenders, General Manager of Canada at BeiGene.
The Health Canada marketing approval for BRUKINSA in R/R MZL is based on efficacy results from two open-label, multicenter, single arm clinical trials. In the MAGNOLIA trial (NCT03846427) (n=68), which included previously treated patients with MZL who had received at least one prior anti-CD20-based therapy, 38% of patients had extranodal MZL, 38% had nodal MZL, 18% had splenic MZL and 6% patients had unknown subtype. In BGB-3111-AU-003 (NCT02343120) (n=20), which included patients with previously treated MZL, 45% had extranodal MZL, 25% had nodal MZL and 30% had splenic MZL. BRUKINSA Total Daily Dose was 320 mg daily, given as 160 mg twice daily or 320 mg once daily.
As assessed by Independent Review Committee per 2014 Lugano Classification, BRUKINSA achieved an overall response rate (ORR) of 68% (95% CI; 56, 79) in the MAGNOLIA trial and 80% (95% CI; 56, 94) in BGB-311-AU-003. In the MAGNOLIA trial, the median response time was 2.8 months (range: 1.7 to 11.1 months).
Serious treatment-emergent adverse events were reported in 35 (40%) patients. The most common serious adverse events (≥ 2% of patients) were pyrexia (8%), pneumonia (7%), influenza (2%), anemia (2%), diarrhea (2%), atrial fibrillation and flutter (2%) and fall (2%).
Of the 88 patients with MZL treated with BRUKINSA, five (6%) patients discontinued treatment due to adverse event. The adverse events leading to treatment discontinuation included two cases of pneumonia (due to COVID-19 pneumonia), one case each of pyrexia, myocardial infarction, and diarrhea. Two (2%) patients had a dose reduction due to adverse events. Death due to adverse events within 30 days of last dose occurred in three (3%) patients. The adverse events leading to death were: COVID-19 pneumonia in two patients (2%) and myocardial infarction in one patient (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.
About myBeiGene Patient Support Program
The myBeiGene patient support program is designed to support patients, caregivers, and healthcare providers with easy access to BRUKINSA. It goes beyond financial assistance and provides practical and emotional support by connecting them to third-party resources that can address their individual needs. Oncology Nurse Advocates are available Monday through Friday from 8 a.m. to 5 p.m. Eastern Time at 1-833-234-4366.
About BRUKINSA
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. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.
To date, BRUKINSA has received more than 20 approvals covering more than 40 countries and regions, including the United States, China, the EU and Great Britain, Canada, Australia, and additional international markets. Currently, more than 40 additional regulatory submissions are in review around the world.
BeiGene Oncology
BeiGene is committed to advancing best- and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D and medical affairs team of approximately 2,900 colleagues dedicated to advancing more than 100 clinical trials that have involved more than 14,500 subjects. Our expansive portfolio is directed predominantly by our internal colleagues supporting clinical trials in more than 45 countries and regions. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. BeiGene currently has three approved medicines discovered and developed in our own labs: BTK inhibitor BRUKINSA in the United States, China, the EU and Great Britain, Canada, Australia and additional international markets; and the non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab as well as the PARP inhibitor pamiparib in China.
BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen, Bristol Myers Squibb, EUSA Pharma and Bio-Thera. We also plan to address greater areas of unmet need globally through our other collaborations including with Mirati Therapeutics, Seagen, and Zymeworks.
In January 2021 BeiGene and Novartis announced a collaboration granting Novartis rights to co-develop, manufacture, and commercialize BeiGene’s anti-PD1 antibody tislelizumab in North America, Europe, and Japan. Building upon this productive collaboration, including a biologics license application (BLA) under FDA review, BeiGene and Novartis announced two new agreements in December 2021 granting Novartis an option to co-develop, manufacture, and commercialize BeiGene’s TIGIT inhibitor ociperlimab that is in Phase 3 development and adding five approved Novartis oncology products to the BeiGene product portfolio across designated regions of China.