Libtayo® (cemiplimab for injection) Letter of Intent Signed by Regeneron Canada and pan-Canadian Pharmaceutical Alliance for Advanced Non-Small Cell Lung Cancer and Locally Advanced Basal Cell Car...
TORONTO, March 6, 2025 /CNW/ - Regeneron Canada Company announced today that it has successfully completed negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) for the reimbursement of Libtayo® (cemiplimab for injection) for advanced non-small cell lung cancer (NSCLC) and locally advanced basal cell carcinoma (BCC).* The Letter of Intent (LOI) was signed on March 3, 2025, which sets the terms of the funding agreement between the pCPA and Regeneron and allows provincial and territorial governments to decide on public reimbursement for their jurisdictions.
"Having a broader range of treatment options for advanced NSCLC is essential," said Shem Singh, Executive Director for Lung Cancer Canada. "We are pleased to see these negotiations move one step closer to expanding the tools in our arsenal to treat appropriate patients."
The LOI supports potential reimbursement in approved Libtayo indications, as follows1:
- 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.
- 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.
- For the treatment of adult patients with locally advanced BCC previously treated with a hedgehog pathway inhibitor.
"This is the first and only treatment for people living with locally advanced BCC who have already tried a hedgehog pathway inhibitor. We are thrilled to see progress towards making this new treatment available given patients' limited options," said Kathleen Barnard, Founder of Save Your Skin. "It gives hope to patients and their families fighting this disease."
"We are pleased to have concluded a successful negotiation for Libtayo in advanced NSCLC and locally advanced BCC with the pan-Canadian Pharmaceutical Alliance. It's an essential step towards making this medicine publicly accessible to patients who could benefit from it in Canada," said Jayne Paterson, Oncology Country Manager of Regeneron Canada. "We look forward to working with provincial, territorial and federal public drug programs across the country to bring this treatment option to patients in need."
*The LOI does not include Quebec for the BCC indication due to the INESSS recommendation.
About Libtayo (cemiplimab for injection)1
Libtayo (cemiplimab for injection) is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells and was invented using Regeneron's proprietary VelocImmune® technology.2 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 and BCC, 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.
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.
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1Libtayo product monograph. September 25, 2024. |
2 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. |
SOURCE Regeneron Canada