BeOne Medicines Successfully Completes Negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) for TEVIMBRA® in first-line Recurrent or Metastatic Nasopharyngeal Carcinoma

Milestone marks an important step forward for Canadians with rare form of head and neck cancer

TORONTO, Oct. 6, 2026 /CNW/ -- BeOne Medicines, a global oncology company, today announced the successful completion of negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) for TEVIMBRA^® (tislelizumab for injection) in combination with gemcitabine and cisplatin for the first-line treatment of adult patients with recurrent or metastatic nasopharyngeal carcinoma (NPC). 

The negotiation process concluded on September 25, 2026, marking an important milestone in the reimbursement pathway and bringing eligible patients one step closer to publicly funded access to TEVIMBRA. This step forward reflects BeOne's ongoing commitment to expanding access to innovative therapies for patients with solid tumors, including rare cancers where treatment options have historically been limited.

Dr. Brandon Meyers, Associate Professor and staff Medical Oncologist at the Juravinski Cancer Centre in Hamilton, Ontario, said:

"For patients living with recurrent or metastatic nasopharyngeal carcinoma, access to first-line treatment options is critical to achieving the best possible outcomes. As a physician caring for individuals with this rare cancer, I see firsthand the challenges patients face when their disease recurs or progresses. The availability of an immunotherapy-based treatment adds an important option to the first-line treatment landscape in an area where therapeutic options have historically been limited."

Kristian Stubbs, General Manager, Canada at BeOne Medicines, said:

"Our work is driven by a commitment to improving patients' lives, and for people living with recurrent or metastatic nasopharyngeal carcinoma, a significant unmet need remains, as no publicly funded first-line immunotherapy option is currently available. With a pCPA agreement now in place, we are focused on working with provincial governments and other stakeholders to help eligible patients across Canada gain access to this treatment as quickly as possible."

Durhane Wong-Rieger, President and CEO, Canadian Organization for Rare Disorders, said:

"Each milestone in the funding pathway brings patients closer to the treatments they need. We welcome this progress and encourage public drug plans across Canada to move quickly toward listing and patient access. For patients and families, timely access to innovative therapies can mean more meaningful time together and better options for care. We hope this progress will translate into timely and equitable access across the country, so that where someone lives does not determine the care they can receive."

Nasopharyngeal Carcinoma in Canada: Rare Cancer, Late Diagnosis and Need for First-Line Immunotherapy Options

Nasopharyngeal carcinoma is a rare form of head and neck cancer that arises in the upper part of the throat behind the nose.¹ It is often diagnosed at advanced stages due to its deep anatomical location and mild early symptoms, making early detection challenging. NPC affects a small but significant number of Canadians each year and there remains a high unmet need for additional immunotherapy options as part of first-line treatment for recurrent or metastatic NPC.²

Healthcare providers and patients may learn more about accessing TEVIMBRA through myBeOneSupport, available at 1-833-234-4366.

About Nasopharyngeal Cancer (NPC) in Canada:

Nasopharyngeal cancer (NPC) is a type of head and neck cancer that starts in the nasopharynx, the upper throat passage behind the nose.¹ NPC is often diagnosed at advanced stages due to its deep anatomical location and mild early symptoms, making early detection challenging.³ In Canada, NPC is considered rare and occurs at rates generally below 1 per 100,000 in non-endemic regions; however, higher incidence has been reported in certain populations, including Inuit communities in Nunavut and the Northwest Territories (~10 per 100,000).² Because NPC statistics are not reported separately in Canada, it is captured within the broader head and neck cancer category; in 2025, an estimated 8,100 Canadians were expected to be diagnosed and approximately 2,200 to die from the disease.⁴

About TEVIMBRA (tislelizumab)

TEVIMBRA is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body's immune cells to detect and fight tumors.

TEVIMBRA is the cornerstone of BeOne's solid tumor portfolio and has shown potential across multiple tumor types and disease settings. The global TEVIMBRA clinical development program includes almost 15,000 patients enrolled to date in 30+ countries and regions across 71 trials, including 21 registration-enabling studies. TEVIMBRA is approved for various solid tumors (see prescribing information) in over 50 countries, and more than 2 million patients have been treated globally. TEVIMBRA reflects the company's commitment to advancing innovative treatment options across a broad range of patients, including patients with significant unmet medical need.

For more information, please consult the TEVIMBRA Product Monograph located here.

IMPORTANT SAFETY INFORMATION

Indications & Clinical Use: TEVIMBRA (tislelizumab for injection) in combination with gemcitabine and cisplatin is indicated for the first-line treatment of adult patients with recurrent or metastatic nasopharyngeal carcinoma (NPC).

TEVIMBRA (tislelizumab for injection) as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after one prior systemic chemotherapy that did not include a PD-(L)1 inhibitor.

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

Geriatrics (≥65 years of age): Based on population pharmacokinetic (PK) analysis, no clinically relevant differences in the PK of TEVIMBRA were observed between patients aged <65 years, patients aged between 65 and 75 years, and patients aged >75 years. Limited safety and efficacy information is available for TEVIMBRA in NPC patients ≥ 65 years.

Contraindications: TEVIMBRA is contraindicated in patients who are hypersensitive to this drug (tislelizumab) or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

Serious Warnings and Precautions:

Immune-mediated adverse reactions: TEVIMBRA may cause severe and fatal immune-mediated adverse reactions, in any organ system or tissue, including: colitis, endocrinopathies, hepatitis, myocarditis, myositis, nephritis with renal dysfunction, organ transplant rejection, pancreatitis, pneumonitis, and severe cutaneous adverse reactions (SCARS e.g., Steven's Johnson Syndrome and Toxic Epidermal Necrolysis).

Infusion-related reactions: TEVIMBRA can cause severe or life-threatening infusion-related reactions including hypersensitivity and anaphylaxis.

Patients receiving allogenic hematopoietic stem cell transplantation (HSCT): Fatal and other serious complications can occur in patients receiving HSCT before or after being treated with a PD-1/PD-L1 blocking antibody.

Other Relevant Warnings and Precautions:

• Immune-related pneumonitis: Monitor for signs and symptoms of pneumonitis. Suspected pneumonitis should be evaluated with radiographic imaging.
  
  
  
  
• Immune-related hepatitis: Monitor for signs and symptoms of hepatitis and changes in liver function with liver function tests.
  
  
  
  
• Immune-related skin reactions: Monitor for signs and symptoms of suspected skin reactions and exclude other causes.
  
  
  
  
• Immune-related colitis: Monitor for signs and symptoms of colitis.
  
  
  
  
• Immune-mediated myocarditis-myositis-myasthenia gravis overlap syndrome-: patients presenting with signs and symptoms of one condition should be monitored for the other two conditions
  
  
  
  
• Thyroid disorders: Monitor for changes in thyroid function and clinical signs and symptoms of thyroid disorders.
  
  
  
  
• Adrenal insufficiency: Monitor for signs and symptoms of adrenal insufficiency.
  
  
  
  
• Hypophysitis/hypopituitarism: Monitor for signs and symptoms of hypophysitis/hypopituitarism.
  
  
  
  
• Diabetes mellitus: Monitor for hyperglycemia or other signs and symptoms of diabetes.
  
  
  
  
• Immune-related nephritis with renal dysfunction: Monitor for changes in renal function and exclude other causes of renal dysfunction.
  
  
  
  
• Other immune-related adverse reactions: myositis, myocarditis, arthritis, polymyalgia rheumatica, pericarditis, immune thrombocytopenia, encephalitis, myasthenia gravis, Sjogren's syndrome, Guillain-Barré syndrome, and hemophagocytic lymphohistiocytosis (HLH).
  
  
  
  
• Solid organ transplant rejection: Consider benefit of treatment with TEVIMBRA vs. risk of possible organ rejection.
  
  
  
  
• Complications of allogenic HSCT: Follow patients closely for evidence of transplant-related complications.
  
  
  
  
• Infusion-related reactions: monitor for signs and symptoms of infusion-related reactions.
  
  
  
  
• Monitoring and laboratory tests: Monitor liver, renal, pituitary, adrenal, and thyroid function prior to initiation and as indicated based on clinical evaluation.
  
  
  
  
• Fertility: No data on the effects of TEVIMBRA on fertility in humans are available.
  
  
  
  
• Contraception: Advise sexually active women of reproductive potential to use effective contraception during treatment and for at least 4 months after the last dose of TEVIMBRA.
  
  
  
  
• Teratogenic risk: Advise women of the potential hazard to a fetus and to avoid becoming pregnant during treatment and for at least 4 months after the last dose of TEVIMBRA.
  
  
  
  
• Breastfeeding: Advise lactating women not to breastfeed during treatment with TEVIMBRA and for at least 4 months after the last dose. 

For More Information:

Please consult the TEVIMBRA Product Monograph here 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.

About BeOne Medicines

BeOne Medicines is a global oncology company that is discovering and developing innovative treatments for cancer patients worldwide. With a portfolio spanning hematology and solid tumours, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. The Company has a growing global team spanning six continents who are driven by scientific excellence and exceptional speed to reach more patients than ever before. To learn more about BeOne, please visit www.beonemedicines.ca and follow us on LinkedIn, X, Facebook and Instagram.

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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 BeOne's plans, commitments, aspirations and goals under the caption "About BeOne." Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne'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; BeOne's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne's reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne's limited experience in obtaining regulatory approvals and commercializing pharmaceutical products; BeOne's 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 BeOne's most recent quarterly or annual report, as well as discussions of potential risks, uncertainties, and other important factors in BeOne'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 BeOne undertakes no duty to update such information unless required by law.

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SOURCE BeOne Medicines