Libtayo® (cemiplimab for injection) Now Reimbursed in Québec for Advanced Non-Small Cell Lung Cancer

TORONTO, Oct. 30, 2025 /CNW/ - Regeneron Canada Company announced today that Libtayo^® (cemiplimab for injection) is now reimbursed by Régie de l'assurance maladie du Québec (RAMQ) in Québec for adults with advanced non-small cell lung cancer (NSCLC).¹ Specifically:

• As monotherapy for first-line treatment of adult patients with NSCLC expressing PD-L1 in ≥50% of tumour cells (Tumour Proportion Score [TPS] ≥50%) as determined by a validated test, with no epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) or c-ROS oncogene 1 (ROS1) aberrations, who have locally advanced NSCLC and are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC.¹
• In combination with platinum‐based chemotherapy for first‐line treatment of adult patients with NSCLC whose tumours have no EGFR, ALK or ROS1 aberrations and is locally advanced where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC.¹

Libtayo is also reimbursed in Ontario, British Columbia, Saskatchewan, Nova Scotia, Newfoundland and Labrador, and New Brunswick for adults with advanced NSCLC and locally advanced basal cell carcinoma (BCC).

Libtayo is also reimbursed in Alberta for the NSCLC combination therapy indication as described above and locally advanced BCC.

"It's incredibly meaningful that Libtayo is now available to eligible Québec patients with advanced NSCLC through RAMQ," said Jayne Paterson, Oncology Country Manager of Regeneron Canada. "We look forward to working with the remaining public drug programs to secure access to Libtayo for all Canadians who could benefit from it."

Lung cancer is the leading cause of cancer deaths worldwide and the most common cancer in Canada.² In 2024, it is estimated that more than 32,000 cases were diagnosed in Canada alone.³ Approximately 80-85% of all lung cancers are NSCLC, with 75% of these cases diagnosed at an advanced stage.^4,5

"Non-small cell lung cancer is a devastating disease that affects many Canadians and their families. The availability of Libtayo provides an additional, much-needed therapeutic option for those whose disease is at an advanced stage," said Dr. Nathalie Daaboul, hematologist-oncologist, Professor (Associate) at Université de Sherbrooke.

The reimbursement of Libtayo for advanced NSCLC is based on data from the Phase 3 EMPOWER-Lung 1 and EMPOWER-Lung 3 trials.^6,7

About Libtayo (cemiplimab for injection)

Libtayo (cemiplimab for injection) is a recombinant human immunoglobulin G4 (IgG4) monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells and was invented using Regeneron's proprietary VelocImmune^® technology.⁸ By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation.

In Canada, in addition to approved indications for certain patients with advanced NSCLC, Libtayo is also approved for the treatment of adult patients with:

• Metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation,
• Cervical cancer who have progressed on or after prior platinum-based chemotherapy and who require additional systemic therapy to treat recurrent or metastatic disease.
• Locally advanced BCC previously treated with a hedgehog pathway inhibitor (in provinces outside of Québec).

For more information about Libtayo, including safety and adverse events, please refer to the Canadian Product Monograph.

About Regeneron in Cancer

We aspire to turn revolutionary discoveries into medicines that can transform the lives of those impacted by cancer. Our team around the world is driven to solve the needs and challenges of those affected by one of the most serious diseases of our time. 
Backed by our legacy of scientific innovation and a deep understanding of biology, genetics and the immune system, we're pursuing potential therapies across more than 30 types of solid tumours and blood cancers. Our cancer strategy is powered by cutting-edge technologies and therapies that can be flexibly combined to investigate potentially transformative treatments for patients. Oncology assets in clinical development comprise nearly half of Regeneron's pipeline, and include checkpoint inhibitors, bispecific antibodies and costimulatory bispecific antibodies. Our approved PD-1 inhibitor Libtayo serves as the backbone of many of our investigational combinations. 

To complement our extensive in-house capabilities, we collaborate with patients, healthcare providers, governments, biopharma companies and each other to further our shared goals. Together, we are united in the mission to serve as a beacon of transformation in cancer care.

About Regeneron

Regeneron is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases. 

Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center^® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.

For more information, please visit www.regeneron.ca.

References:

1. L'Institut national d'excellence en santé et en services sociaux (INESSS). Libtayo. Available at: https://www.inesss.qc.ca/en/themes/medicaments/drug-products-undergoing-evaluation-and-evaluated/extract-notice-to-the-minister/libtayo-cpnpc-6881.html.
2. "Lung Cancer in Canada." Government of Canada. Available at: https://www.canada.ca/en/public-health/services/publications/diseases-conditions/lung-cancer.html.
3. "Lung and Bronchus Cancer Statistics." Canadian Cancer Society. Available at: https://cancer.ca/en/cancer-information/cancer-types/lung/statistics.
4. "About Lung Cancer." Lung Cancer Canada. Available at: https://lungcancercanada.ca/about-lung-cancer/about-lung-cancer-overview/.
5. Zhang BB et al. Short-term Efficacy of Different First-Line Chemotherapy Regimens for Advanced Non-small Cell Lung Cancer: a Network Meta-Analysis. Clin Transl Sci. 2020;13:589–98. Available at: https://ascpt.onlinelibrary.wiley.com/doi/full/10.1111/cts.12744.
6.  First-line cemiplimab monotherapy and continued cemiplimab beyond progression plus chemotherapy for advanced non-small-cell lung cancer with PD-L1 50% or more (EMPOWER-Lung 1): 35-month follow-up from a mutlicentre, open-label, randomised, phase 3 trial https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(23)00329-7/abstract.
7. Baramidze A, Makharadze T, Gogishvili M, et al. Cemiplimab plus chemotherapy vs chemotherapy in advanced NSCLC: 5-year results from phase 3 EMPOWER-Lung 3 Part 2 trial. Presented at: 2025 IASLC World Conference on Lung Cancer; September 6-10,2025; Barcelona, Spain. Oral presentation MA10.09.
8. .Burova E, Hermann A, Waite J, et al. Characterization of the Anti–PD-1 Antibody REGN2810 and its Antitumor Activity in Human PD-1 Knock-in Mice. Mol Cancer Ther. 2017;16(5):861-870. Available at: https://pubmed.ncbi.nlm.nih.gov/28265006/.

SOURCE Regeneron Canada

Media Relations, Taylor Skott, Tel: [phone], [email protected]