Adults living with chronic lymphocytic leukemia (CLL) in Ontario and Quebec now have access through public reimbursement to BRUKINSA® (zanubrutinib)

• BRUKINSA is now listed on the RAMQ and ODB formularies.
• Two global Phase 3 trials in adults with CLL demonstrated superior efficacy for BRUKINSA in first line and relapsed/refractory settings.
• Approximately 2,000 Canadians are diagnosed every year with CLL, the most common form of leukemia in adults.

TORONTO, Jan. 31, 2024 /CNW/ – BeiGene, Ltd. (NASDAQ: BGNE) (HKEX: 06160) (SSE: 688235), a global biotechnology company is pleased to announce that the Governments of Ontario and Quebec have publicly listed BRUKINSA^® (zanubrutinib), a second generation inhibitor of Bruton’s tyrosine kinase (BTK), for the treatment of adults living with chronic lymphocytic leukemia (CLL), the most common form of leukemia in adults. The Régie de l’assurance maladie du Québec listing came into effect December 13, 2023, and the Ontario Drug Benefit Program (ODB) added BRUKINSA on January 12, 2024.

CLL is a type of blood cancer that is incurable and slow growing. The condition is more common in men and occurs mainly in people over 60, with the average age of diagnosis in the early 70s.¹ As there are no curative treatments for individuals living with CLL, they require continual treatment. During the course of their treatment, they might stop responding, relapse or become intolerant to their medication.

BRUKINSA received its Notice of Compliance (NOC) for CLL from Health Canada on May 24^th, 2023.   In addition to the new ODB and RAMQ listings, it is available through private insurance plans.  BRUKINSA provides additional clinical benefit through improved progression-free survival. It is also better tolerated and has a favourable toxicity profile compared to current chemoimmunotherapy and BTK inhibitor options.^2,3,4

The Canadian Agency for Drugs and Technologies in Health (CADTH) recommended BRUKINSA be listed on the provinces’ public health plans based on evidence from 2 ongoing phase lll, open-label randomized controlled trials (RCTs) (SEQUOIA cohort 1 and ALPINE). These trials demonstrated that treatment with zanubrutinib resulted in added clinical benefit for patients with CLL. The SEQUOIA trial cohort (N=479) demonstrated a statistically significant difference (P<0.0001) in progression-free survival (PFS) between zanubrutinib and bendamustine-rituximab treatment arms in patients with treatment-naïve CLL. In the SEQUOIA trial, median PFS had not yet been reached in the zanubrutinib arm, whereas in the bendamustine-rituximab arm, the median PFS was 33.7 months (95% confidence interval (CI), 28.1 months to not estimable (NE]). In patients with r/r CLL, the ALPINE trial (N=652) demonstrated a statistically significant difference (P = 0.0006) in overall response rate (ORR) between the zanubrutinib and ibrutinib treatment arms (78.3% and 62.5% respectively; HR = 1.25, 95% CI, 1.10 to 1.41), demonstrating noninferiority as well as superiority of zanubrutinib to ibrutinib. ²

“Timely access to medicines like BRUKINSA cannot be underestimated,” said Dr. Christine Chen, MEd, MD, FRCPC, Clinician Investigator, Princess Margaret Cancer Centre. “This medication was approved by Health Canada to treat patients with Chronic Lymphocytic Leukemia based on its clear clinical benefit and superior progression-free survival and now, thanks to the Government of Ontario, it is accessible through the ODB. This is such good news for patients, their families and the physicians who treat them.”

“I am excited by the decision of the Governments of Ontario and Quebec to provide CLL patients access to BRUKINSA. This is a most welcome and significant development for those living with this blood cancer,” said Peter Brenders, General Manager, BeiGene Canada. “Including innovative drugs on pharmacare formularies is the foundation of good health care. Drug access is a priority, and we are working closely with the other provinces to include BRUKINSA on their public drug plans.”

“We applaud the listing of BRUKINSA on the Ontario and Quebec provincial formularies which means that CLL patients in these provinces will have access to this medication,” says Raymond Vles, Board Chair, CLL Canada.  “It is essential that Canadians are able to benefit from approved treatments by way of public funding no matter where they live, and we look forward to BRUKINSA being listed by the other provinces.”

The myBeiGene^® patient support program is designed to support patients, caregivers, and healthcare providers with access to BRUKINSA. It goes beyond financial assistance 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. Case managers are available Monday through Friday from 8 a.m. to 8 p.m. Eastern Time at 1-833-234-4366.

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, 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.

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, including being better tolerated and having a favourable toxicity profile compared to other medicines; whether including BRUKINSA on the Ontario and Quebec provincial formularies will provide greater access to patients; 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)

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 Canada

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