BeOne Medicines Receives Positive Reimbursement Recommendations from CDA-AMC and INESSS for TEVIMBRA in First-Line Nasopharyngeal Carcinoma

Canada's Health Technology Assessment (HTA) agencies affirm the clinical value of TEVIMBRA in first-line recurrent or metastatic nasopharyngeal carcinoma (NPC), a rare form of head and neck cancer

Positive reimbursement recommendations mark an important step toward securing public funding for eligible patients who currently lack a first-line NPC chemotherapy-immunotherapy treatment option in Canada

TORONTO, May 28, 2026 /CNW/ - BeOne Medicines, a global oncology company, today announced that Canada's Drug Agency (CDA-AMC) and the Institut national d'excellence en santé et en services sociaux (INESSS), issued positive reimbursement recommendations 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). These recommendations follow Health Canada's approval of TEVIMBRA in December 2025 for this indication and represent an important step toward access for patients, as there is currently no publicly funded first-line immunotherapy option for recurrent or metastatic NPC 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

The recommendations are based on assessments by CDA-AMC and INESSS of clinical and economic evidence, as well as input from physicians, patient groups, and public drug programs. The clinical evidence is based on results from the RATIONALE-309 trial (NCT03924986), a multicenter, Phase 3 study of TEVIMBRA in combination with chemotherapy (gemcitabine and cisplatin) versus placebo combined with gemcitabine and cisplatin as first-line treatment for patients with recurrent or metastatic nasopharyngeal cancer. The primary endpoint was met at the first prespecified interim analysis in which TEVIMBRA significantly prolonged progression free survival (PFS) in the intention-to-treat (ITT) population. TEVIMBRA plus chemotherapy was generally well tolerated. The most common Grade 3 or higher treatment-emergent adverse events (≥ 20%) associated with TEVIMBRA given in combination with chemotherapy were neutropenia, anemia, and leukopenia.³ Recently published three-year follow-up data show that TEVIMBRA plus chemotherapy demonstrates a sustained and clinically meaningful PFS improvement, reinforcing the long-term efficacy and safety profile of the treatment regimen.⁴

"These positive recommendations from CDA-AMC and INESSS represent an important milestone in the Canadian reimbursement pathway," said Kristian Stubbs, General Manager, Canada, BeOne Medicines. "We will continue to work collaboratively with provincial governments and other stakeholders to help bring this important treatment option to eligible patients across Canada."

Additional information regarding the reimbursement recommendations, including clinical criteria and associated conditions, is available on the CDA-AMC and INESSS websites.

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.⁵ 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.⁶

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 more than 15,000 patients enrolled to date in 30+ countries and regions across 72 trials, including 22 registration-enabling studies.

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.

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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¹ The Canadian Cancer Society. What is nasopharyngeal cancer? Available at: https://cancer.ca/en/cancer-information/cancer-types/nasopharyngeal/what-is-nasopharyngeal-cancer?

² Spreafico A, Winquist E, Ho C, O'Sullivan B, Bouganim N, Chua N, Doucette S, Siu L, Hao D. A Canadian Perspective on Systemic Therapy for Recurrent or Metastatic Nasopharyngeal Carcinoma, Review. Current Oncology, 2025 Jan 17;32(1):48. https://doi.org/10.3390/curroncol32010048 PMID: 39851964 PMCID: PMC11763457

³ Tevimbra Product Monograph. https://beonemedicines.ca/en/wp-content/uploads/pdfs/Tevimbra_PM_English.pdf

⁴ Yang Y, Yen C, Pan J, et al. First-Line Tislelizumab Plus Chemotherapy for Recurrent or Metastatic Nasopharyngeal Cancer: Three-Year Follow-Up of the Phase 3 RATIONALE-309 Randomized Clinical Trial. JAMA Oncol. Published online February 26, 2026. doi:10.1001/jamaoncol.2026.0020

⁵ Wei, X., Chen, B., Wang, Z., et al. (2024). Nasopharyngeal cancer risk assessment by country or region worldwide from 1990 to 2019. BMC Public Health, 24, 1931. Https://doi.org/10.1186/s12889-024-19228-9

⁶ Canadian Cancer Society. (2025). Head and neck cancer statistics (includes nasopharyngeal cancer; Canada 2025 estimates). Retrieved from https://cancer.ca/en/cancer-information/cancer-types/nasopharyngeal/statistics

SOURCE BeOne Medicines