• Two global Phase 3 trials in adults with CLL demonstrated superior efficacy for BRUKINSA in first line and relapsed/refractory settings

TORONTO, May 30, 2023 /CNW/ - BeiGene, Ltd. (NASDAQ: BGNE) (HKEX: 06160) (SSE: 688235), a global biotechnology company, announced today that BRUKINSA (zanubrutinib), a Bruton's tyrosine kinase (BTK) inhibitor, has been granted a Notice of Compliance from Health Canada for the treatment of adult patients with chronic lymphocytic leukemia (CLL).

This is the fourth Canadian approval for BRUKINSA, following authorizations for: adult patients with Waldenström's macroglobulinemia; adult patients who have received at least one prior therapy for the treatment of mantle cell lymphoma; and adult patients with relapsed or refractory marginal zone lymphoma.¹

The latest Health Canada approval of BRUKINSA for CLL is based on positive efficacy results and a favourable safety profile from two global Phase 3, randomized, open-label, multicentre clinical trials: SEQUOIA (NCT03336333), comparing single agent zanubrutinib against the chemotherapy agent, bendamustine plus rituximab (BR) in patients with previously untreated CLL, and ALPINE (NCT03734016), comparing zanubrutinib against ibrutinib in patients with relapsed or refractory (R/R) CLL.¹

Typically diagnosed among individuals in their early 70s, CLL is a slow-growing, incurable blood cancer and is the most common leukemia in adults.² 

"Because CLL is a chronic disease with many patients often living with multiple health conditions, access to effective treatment options with safe and favourable tolerability profiles is critical," says Dr. Christine Chen, MMEd, MD, FRCPC, Clinician Investigator, Princess Margaret Cancer Centre. "That is why the approval of zanubrutinib is seen as a clinical home run - not only did it demonstrate a significant clinical benefit in the first line CLL setting but it also delivered superior efficacy vs ibrutinib in patients with relapsed or refractory disease and did so with less toxicity. And because most CLL patients are ultimately treated on and off for years, zanubrutinib may represent a safer and more effective option for these patients."

In the SEQUOIA trial, which examined those with previously untreated CLL, zanubrutinib achieved its primary endpoint, demonstrating a statistically significant improvement in progression free survival (PFS) compared to BR, at median follow-up of approximately 26.2 months.¹ 

Zanubrutinib met its primary endpoint in the interim ALPINE analysis demonstrating a superior overall response rate (ORR) of 78.3% vs. 62.5% (95% CI and p-value) compared to ibrutinib at 12 months.¹ Moreover, the incidence of atrial fibrillation and flutter of any grade in the interim ALPINE analysis was substantially lower with zanubrutinib vs. ibrutinib (2% vs 8%).¹

Considered the largest head-to-head study of BTK inhibitors in R/R CLL, the final ALPINE trial data was presented in a late-breaking session at the 64th American Society of Hematology Annual Meeting in December 2022 and simultaneously reported in the New England Journal of Medicine.^3,4

"CLL Canada applauds continued innovation when it comes to addressing the needs of Canadians who live with CLL. The approval of zanubrutinib represents a significant advance for patients who can benefit from an additional treatment option," says Raymond Vles, Board Chair, CLL Canada. "More importantly, becoming informed and connecting with the CLL patient community will enable people with CLL to discuss with their doctor the treatment and dosing options that will work best for them and their lifestyle."

If anyone knows the importance of community when you receive a cancer diagnosis it would be Jamie Campbell. The veteran Toronto Blue Jays commentator and host of Blue Jays Central on Sportsnet was diagnosed with CLL two years ago and began treatment last year. "The fans and my baseball family really got behind me and lifted me up when I needed it most and they still are," says Campbell. "And though the mental "hug" you get from family and friends helps with managing the disease, it's just as important to have choices when it comes to treatment options because patients have different needs and are at different stages of their disease."

"BeiGene Canada is proud of our company's ongoing focus and commitment to researching and developing innovative oncology therapies," says Peter Brenders, General Manager, BeiGene Canada. "The development of treatments like zanubrutinib reflects BeiGene's dedication to finding better ways to improve the lives of cancer patients and their families."

CLL is a type of blood cancer. Over 2,200 people in Canada are diagnosed with CLL each year. CLL is more common in men and occurs mainly in people over 60, with the average age of diagnosis in the early 70s. When most of the cancer cells are found in the blood stream and the bone marrow, it is called CLL.

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. Because 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 and is indicated in Canada for the treatment of adult patients with: Waldenström's macroglobulinemia; mantle cell lymphoma who have received at least one prior therapy; marginal zone lymphoma who have received at least one prior anti-CD20-based therapy; and, CLL.

For adult patients with CLL, BRUKINSA is dosed as two 80 mg capsules taken orally twice a day (twelve hours apart) OR four 80 mg capsules taken once a day.

Headquartered in Toronto, Ontario, BeiGene Canada is the country affiliate of global biotechnology company BeiGene, specialized 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 www.beigene.ca. 

BeiGene is a global biotechnology company that is discovering and developing innovative oncology 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 9,400 colleagues spans five continents, with administrative offices in Basel; Beijing; and Cambridge, U.S. To learn more about BeiGene, please visit www.beigene.com and follow us on Twitter at @BeiGeneGlobal.

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 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 the potential for BRUKINSA to provide clinical benefit to patients with CLL; the potential for BRUKINSA to be a safer and more effective treatment option for patients; the future development, regulatory filing and approval, commercialization, and market access 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, 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 and commercialization of its drug candidates and achieve and maintain profitability; and the impact of the COVID-19 pandemic on BeiGene's clinical development, regulatory, commercial, manufacturing, and other operations, as well as 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;
• for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy;
• for the treatment of adult patients with marginal zone lymphoma who have received at least one prior anti-CD20-based therapy; and,
• for the treatment of adult patients with CLL.

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.

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.

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).

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.

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 is also available by calling 1-877-828-5598.

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