Health Canada Approves BRUKINSA® (zanubrutinib) for the Treatment of Relapsed or Refractory Follicular Lymphoma

• Follicular lymphoma (FL) is the 2nd most common type of non-Hodgkin lymphoma (NHL)
• This is the fifth Canadian therapeutic indication for BRUKINSA

TORONTO, Feb. 7, 2024 /CNW/ – BeiGene, Ltd. (Nasdaq: BGNE) (HKEX: 06160) (SSE: 688235), a global biotechnology company, today announced it received Health Canada authorization for the use of BRUKINSA^® (zanubrutinib) in combination with obinutuzumab for the treatment of adult patients with relapsed or refractory grade 1, 2 or 3a follicular lymphoma (FL) who have received at least two prior systemic therapies.

This marks the fifth hematology indication for BRUKINSA in Canada following approvals for the treatment of adult patients with Waldenström’s macroglobulinemia (WM); adult patients who have received at least one prior therapy for the treatment of mantle cell lymphoma (MCL); adult patients with relapsed or refractory marginal zone lymphoma (MZL) and adult patients with chronic lymphocytic leukemia (CLL).

“Having a new safe, effective and well-tolerated treatment choice for Canadians living with follicular lymphoma is an important achievement,” said Peter Brenders, General Manager, BeiGene Canada. “We are hopeful that even more patients can now benefit from BRUKINSA and are proud to highlight BeiGene’s unwavering commitment to improving cancer patient outcomes and having a positive impact on their lives.”

The Canadian approval is based on positive results from ROSEWOOD (NCT03332017), a pivotal global, randomized, open-label Phase 2 study comparing the highly selective Bruton’s tyrosine kinase (BTK) inhibitor BRUKINSA combined with obinutuzumab vs. obinutuzumab alone. At 20.2 months the ROSEWOOD trial met its primary endpoint, demonstrating a statistically significantly higher Objective Response Rate (ORR), as assessed by the Independent Review Committee (IRC). BRUKINSA plus obinutuzumab was generally well-tolerated, with safety results consistent with previous studies of both medicines and showed consistent benefit over obinutuzumab in pre-specified subgroups. Additionally, the median progression-free survival (PFS) for patients treated with BRUKINSA plus obinutuzumab was 28.0 months, compared to 10.4 months for patients treated with only obinutuzumab (HR: 0.50 [95% CI: 0.33, 0.75]; P = 0.0007).  ^1,2,3

“Individuals living with follicular lymphoma often relapse or may respond poorly to subsequent treatments,” said Dr. Sarit Assouline, Hematologist, McGill University and Jewish General Hospital. “The approval of BRUKINSA is a game changer with a demonstrated clinical benefit that provides a chemotherapy-free oral medication option for eligible patients with relapsed or refractory follicular lymphoma.”

“Lymphoma Canada is the only national charity focused solely on lymphoma.  Our goals include raising awareness about lymphoma and amplifying the voices of patients and their families in Canada,” said Antonella Rizza, Chief Executive Officer of Lymphoma Canada. “Approval of this therapy for relapsed or refractory follicular lymphoma patients is exciting news for those living with this blood cancer.”

FL is the second most common type of non-Hodgkin lymphoma (NHL), accounting for 22% of all NHL cases. While patients with FL may experience very few symptoms or none at all, the most common symptom is a painless swelling in the neck, armpit or groin regions caused by enlarged lymph nodes. Patients may also experience fatigue, loss of appetite, or itchy skin. FL is a slow-growing cancer but can become more aggressive over time. While FL remains incurable, individuals with this condition can live a long time. FL usually occurs in people 50 years of age or older, and the average age at diagnosis is 59. It is slightly more common in women than in men. ^4,5

BRUKINSA blocks a specific protein in the body that helps cancer cells live and grow. This protein is called “Bruton’s Tyrosine Kinase.”  By blocking this protein, BRUKINSA may help kill and reduce the number of cancer cells and slow the spread of the cancer. BRUKINSA 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. As new BTK protein is continuously synthesized, BRUKINSA was specifically designed by BeiGene 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 several disease relevant tissues.

Headquartered in Toronto, Ontario, BeiGene Canada is the country affiliate of global biotechnology company BeiGene, specializing in the discovery and development of novel, affordable and accessible oncology medications. With a highly experienced and dedicated Canadian leadership team headed by pharmaceutical executive Peter Brenders, BeiGene Canada is committed to delivering new cancer therapies to the Canadian oncology community, including patients, caregivers, clinicians, and investigators. For more information about BeiGene Canada please visit beonemedicines.ca.

BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents. To learn more about BeiGene, please visit www.beigene.com and follow us on LinkedIn, X (formerly known as Twitter) and Facebook.

The myBeiGene^® patient support program is designed to support patients, caregivers, and healthcare providers with access to BRUKINSA. It goes beyond financial assistance support to provide patients and caregivers with education about their disease and treatment with BRUKINSA, as well as provide practical and emotional support by connecting them to third-party resources that can address their individual needs. Oncology Case Managers are available Monday through Friday from 8 a.m. to 8 p.m. Eastern Time at 1-833-234-4366.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding BeiGene’s ability to provide a safe, effective and well tolerated treatment for Canadians living with FL; the potential benefit of BRUKINSA to patients with FL; BeiGene’s commitment to improving cancer patient outcomes; BeiGene’s advancement and commercialization of BRUKINSA; and BeiGene’s plans, commitments, aspirations, and goals under the heading “About BeiGene.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeiGene’s ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene’s reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene’s subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.

Indications & Clinical Use:

BRUKINSA (zanubrutinib) is indicated:

• for the treatment of adult patients with Waldenström’s macroglobulinemia (WM)
• for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy
• for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy
• for the treatment of adult patients with chronic lymphocytic leukemia (CLL)
• in combination with obinutuzumab for the treatment of adult patients with relapsed or refractory grade 1, 2 or 3a follicular lymphoma (FL) who have received at least 2 prior systemic therapies.

Pediatrics (<18 years of age): No safety and efficacy data are available; therefore, Health Canada has not authorized an indication for pediatric use.

Geriatrics (>65 years of age): No clinically relevant differences in safety or efficacy were observed between patients ≥65 years and those younger than 65 years.

Contraindications:

BRUKINSA is contraindicated in patients who are hypersensitive to zanubrutinib or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

Most Serious Warnings and Precautions:
Healthcare professional supervision required: Treatment with BRUKINSA should be initiated and supervised by a Qualified Healthcare Practitioner experienced in the use of anticancer therapies.
Serious hemorrhage: (see the BRUKINSA Product Monograph, WARNINGS AND PRECAUTIONS, Hemorrhage).

Other Relevant Warnings and Precautions:
Second primary malignancies: Monitor patients for skin cancer and advise patients to use sun protection.
Atrial fibrillation and flutter: Monitor for signs and symptoms of atrial fibrillation and atrial flutter and manage as appropriate.
Driving and operating machinery: Fatigue, dizziness, and asthenia have been reported in some patients taking BRUKINSA and should be considered when assessing a patient’s ability to drive or operate machines.
Cytopenias: Monitor complete blood counts regularly during treatment.
Infections: Monitor patients for signs and symptoms of infection and treat appropriately. Consider prophylaxis according to standard of care in patients who are at increased risk for infections.
Tumour lysis syndrome: Monitor patients closely and treat as appropriate.
Peri-operative considerations: Consider the benefit-risk of withholding BRUKINSA for 3 to 7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding.
Fertility: No data on the effects of BRUKINSA on fertility in humans are available.
Teratogenic risk: Advise women of the potential hazard to a fetus and to avoid becoming pregnant during treatment and for at least 1 week after the last dose of BRUKINSA. Advise men to avoid fathering a child while receiving BRUKINSA and for at least 3 months following the last dose of BRUKINSA.
Breastfeeding: Advise lactating women not to breastfeed during treatment with BRUKINSA and for at least two weeks following the last dose.
Interstitial lung disease (ILD): Monitor patients for signs and symptoms of ILD.
Hemorrhage: Patients should be monitored for signs of bleeding.

For More Information:

Please consult the BRUKINSA Product Monograph at BRUKINSA.ca/PM for important information relating to adverse reactions, drug interactions, and dosing information, which have not been discussed in this piece.

The Product Monograph can also be made available by calling 1-877-828-5598.

References____________________________________________________________________________________________

SOURCE BeiGene

For further information: Media Contact, Energi PR, Alanna Fox, Alanna.Fox@energipr.com, 416-726-1913