Regeneron Canada Reaches New Agreement Deal for Cancer Drug Libtayo

Regeneron Canada, a biotechnology company focused on developing treatments for serious diseases, has reached a pricing and funding agreement with the pan-Canadian Pharmaceutical Alliance (pCPA) for its injectable drug, Libtayo (cemiplimab), to treat advanced non-small cell lung cancer (NSCLC) and locally advanced basal cell carcinoma (BCC).

The agreement was signed in a letter of intent on March 3 to set the groundwork for whether government health programs in different provinces and territories will cover the drug's cost for patients, according to a news release by Regeneron Canada.

However, each province and territory must still decide on its own whether to include Libtayo in its public healthcare system.

Libtayo, a monoclonal antibody, works by targeting the immune receptor PD-1 on T cells, helping to prevent cancer cells from immune system attacks.

In addition to now being approved for NSCLC and BCC, Libtayo is used to treat cutaneous squamous cell carcinoma (CSCC) in patients who are not candidates for curative surgery or radiation, and for cervical cancer in patients who have progressed following platinum-based chemotherapy and require further systemic therapy.

Regeneron has listed the wholesale acquisition cost of Libtayo at $10,606.76, making public reimbursement a crucial factor in ensuring access for patients.

NSCLC is the most common lung cancer, with 2.1 million cases worldwide in 2022. It occurs when lung cells grow uncontrollably, often spreading before symptoms appear.

Treatment includes chemotherapy, immunotherapy, targeted therapy, radiation and surgery in the early stages.

Immunotherapy drugs such as Libtayo offer new options for advanced cases.

Like NSCLC, BCC is the most common skin cancer, with 3.6 million U.S. cases annually.

While surgery is effective, advanced BCC may require hedgehog pathway or immune checkpoint inhibitors, according to the news release.

"Having a broader range of treatment options for advanced NSCLC is essential," said Shem Singh, executive director for Lung Cancer Canada, in the news release. "We are pleased to see these negotiations move one step closer to expanding the tools in our arsenal to treat appropriate patients."

If provinces and territories choose to list Libtayo from this agreement, it will become accessible to more patients who may not otherwise afford the treatment.

According to the release, the agreement supports reimbursement for monotherapy as a first-line treatment for adult NSCLC patients with a high PD-L1 expression of tumor cells of 50% or more and no specific genetic mutations.

It also covers combinat

ion therapy with platinum-based chemotherapy for first-line NSCLC patients with no epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) or c-ROS oncogene 1 (ROS1) aberrations.

Lastly, it will cover the treatment of adult patients with locally advanced BCC previously treated with a hedgehog pathway inhibitor.

Kathleen Barnard, founder of Save Your Skin, shared this development 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."

While this agreement marks an important step toward public reimbursement, each province and territory must now decide whether to include Libtayo in their healthcare plans.

These decisions will determine how widely accessible the drug becomes for patients across Canada battling advanced NSCLC and BCC.

If successfully adopted, Libtayo could offer new hope for individuals facing these life-threatening cancers.