Health Canada Approves TEVIMBRA® (tislelizumab for injection) in Combination with Gemcitabine and Cisplatin for the First-Line Treatment of Adult Patients with Recurrent or Metastatic Nasopharynge...

Nasopharyngeal Carcinoma is a rare and debilitating disease with limited effective treatment options currently available to Canadian patients

Approval supported by results of the RATIONALE-309 study demonstrating statistically significant improvement in progression-free survival

TORONTO, Dec. 23, 2025 /CNW/ - BeOne Medicines, a global oncology company, today announced that Health Canada has granted a Notice of Compliance (NOC), approving 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). This is the first approved indication for TEVIMBRA in Canada.

Nasopharyngeal carcinoma is a rare form of head and neck cancer that arises in the upper part of the throat behind the nose.¹ NPC affects a small but significant number of Canadians each year and there are considerable disparities in accessing immunotherapy as part of first-line treatment for recurrent or metastatic NPC.²

"This approval represents an important milestone and treatment advancement for Canadians diagnosed with nasopharyngeal carcinoma," said Dr. Desiree Hao, Head and Neck Medical Oncologist at Arthur J.E. Child Comprehensive Cancer Centre and Professor of Medicine, University of Calgary. "Adult patients with recurrent or metastatic NPC have long faced limited therapeutic choices. The arrival of TEVIMBRA for Canadian NPC patients is a welcomed treatment option to help address this critical unmet need."

The Health Canada approval of TEVIMBRA was based upon the results from RATIONALE-309 (NCT03924986), a multicentre, Phase 3 randomized, double-blind trial, in which patients received either TEVIMBRA in combination with gemcitabine plus cisplatin, or placebo in combination with gemcitabine plus cisplatin. The primary endpoint was met at the first prespecified interim analysis demonstrating that TEVIMBRA significantly prolonged progression free survival (PFS) in the intent-to-treat (ITT) population (HR 0.52 [95% CI:0.38, 0.73] p<0.0001), showing a 48% reduction in the risk of disease progression or death. The median PFS in the TEVIMBRA plus chemotherapy arm was 9.2 months compared to 7.4 months in the placebo plus chemotherapy arm.³

TEVIMBRA plus chemotherapy was generally well tolerated. The most common ≥Grade 3 treatment-emergent adverse events (≥ 20%) associated with TEVIMBRA given in combination with chemotherapy were neutropenia, anemia, and leukopenia.³

"This Health Canada approval is an important step in making a new treatment option available to Canadian patients living with NPC," said Kristian Stubbs, General Manager, Canada, BeOne Medicines. "We believe that no one should face this devastating disease alone and we are committed to making TEVIMBRA broadly accessible to Canadian NPC patients. We look forward to partnering with stakeholders who share a sense of urgency to improve the standard of care for NPC patients in Canada."

TEVIMBRA is anticipated to be commercially available in the first half 2026.

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.⁴ 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, for which it is estimated 8,100 Canadians will be diagnosed and 2,200 will die in 2025.⁵

About TEVIMBRA (tislelizumab)

Tislelizumab is a humanized immunoglobulin G4 (IgG4) variant monoclonal antibody against PD-1. Binding to the extracellular domain of PD-1 receptor blocks the interaction with both PD-L1 and PD‑L2 ligands, inhibiting T-cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumours and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumours.³

TEVIMBRA is the foundational asset of BeOne's solid tumour portfolio. The global TEVIMBRA clinical development program includes almost 14,000 patients enrolled to date in 35 countries and regions across 70 trials, including 22 registration-enabling studies. For more information, please consult the TEVIMBRA Product Monograph located at https://beonemedicines.ca/wp-content/uploads/2025/12/1.3.1-TEVIMBRA-PM-NPC-Dec-18-2025.pdf.

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).

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.
• 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 at https://beonemedicines.ca/wp-content/uploads/2025/12/1.3.1-TEVIMBRA-PM-NPC-Dec-18-2025.pdf 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 domiciled in Switzerland that is discovering and developing innovative treatments that are more accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumours, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of nearly 12,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them. To learn more about BeOne, please visit www.beonemedicines.ca and follow us on LinkedIn, X, Facebook and Instagram.

Forward Looking Statement

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