Regeneron Canada Company announced that Libtayo (cemiplimab for injection) has achieved reimbursement by public drug programs across seven Canadian provinces for the treatment of advanced non-small cell lung cancer (NSCLC) and locally advanced basal cell carcinoma (BCC). The PD-1 inhibitor is now covered in Ontario, British Columbia, Saskatchewan, Nova Scotia, Newfoundland and Labrador, New Brunswick, and Quebec, with Alberta providing coverage for specific indications.
Approved Indications and Patient Populations
Libtayo is reimbursed for two distinct NSCLC treatment approaches. As monotherapy, it targets first-line treatment of adult patients with NSCLC expressing PD-L1 in ≥50% of tumor cells (Tumor Proportion Score [TPS] ≥50%) as determined by a validated test, specifically for patients 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.
The drug is also approved in combination with platinum-based chemotherapy for first-line treatment of adult patients with NSCLC whose tumors 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.
For BCC, Libtayo is indicated for the treatment of adult patients with locally advanced BCC previously treated with a hedgehog pathway inhibitor, though this indication is not covered in Quebec.
Clinical Significance and Disease Burden
Lung cancer represents the leading cause of cancer deaths worldwide and the most common cancer in Canada. In 2024, it is estimated that more than 32,000 cases were diagnosed in Canada alone. Approximately 80-85% of all lung cancers are NSCLC, with 75% of these cases diagnosed at an advanced stage.
"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 and Associate Professor at Université de Sherbrooke.
Dr. Barbara Melosky, clinical professor of medical oncology at the University of British Columbia, echoed this sentiment, emphasizing the importance of having additional therapeutic options for patients with advanced-stage disease.
Supporting Clinical Evidence
The reimbursement decisions are based on data from pivotal Phase 3 clinical trials. For advanced NSCLC, the approvals rely on results from the EMPOWER-Lung 1 and EMPOWER-Lung 3 trials. The EMPOWER-Lung 1 study provided 35-month follow-up data for first-line cemiplimab monotherapy and continued cemiplimab beyond progression plus chemotherapy for advanced NSCLC with PD-L1 50% or more. The EMPOWER-Lung 3 trial presented 5-year results comparing cemiplimab plus chemotherapy versus chemotherapy alone in advanced NSCLC at the 2025 IASLC World Conference on Lung Cancer.
For locally advanced BCC, the reimbursement is supported by the EMPOWER-BCC 1 trial, which provided primary analysis of phase 2 results for cemiplimab in patients with metastatic basal cell carcinoma who progressed on or were intolerant to hedgehog inhibitors.
Mechanism of Action and Technology Platform
Libtayo is a recombinant human immunoglobulin G4 (IgG4) monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells, invented using Regeneron's proprietary VelocImmune technology. By binding to PD-1, Libtayo blocks cancer cells from using the PD-1 pathway to suppress T-cell activation, thereby enhancing the immune system's ability to recognize and attack cancer cells.
Broader Treatment Landscape
Beyond the newly reimbursed indications, Libtayo is also approved in Canada for treating adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation, and cervical cancer patients who have progressed on or after prior platinum-based chemotherapy and require additional systemic therapy to treat recurrent or metastatic disease.
Market Access Progress
"It's incredibly meaningful that Libtayo is now available to eligible patients with advanced NSCLC and locally advanced BCC through public drug programs in these provinces," 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."
The widespread provincial coverage represents a significant milestone in patient access, particularly given that BCC is the most common form of skin cancer, with more than 80,000 people diagnosed with BCC each year in Canada. While early-stage BCC has a cure rate exceeding 90% when caught early and removed, some patients develop advanced BCC, characterized as large, deep, aggressive, or recurrent tumors.
