Libtayo® (cemiplimab for injection) Receives Health Canada Approval for Adjuvant Treatment of High-Risk Cutaneous Squamous Cell Carcinoma

TORONTO, Aug. 6, 2026 /CNW/ -- Regeneron Canada Company announced today that Health Canada has issued a Notice of Compliance (NOC) for Libtayo^® (cemiplimab for injection) for the adjuvant treatment of adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation.

"The approval of this new indication for cemiplimab demonstrates continued advancement in the management of high-risk CSCC in Canada as the first and only positive, randomized trial evaluating adjuvant treatment for this disease. The highly significant and clinically meaningful hazard ratio of 0.32 offers clinicians a new option to address the needs of patients," said Dr. Marcus Butler, Melanoma/Skin Oncology Site Lead, Princess Margaret Cancer Centre.

"This approval is a significant step forward in our mission to develop meaningful advancements for people living with high-risk CSCC. We're proud to continue to push the boundaries of science to find solutions for Canadians living with skin cancer," said Jayne Paterson, Country Manager, Regeneron Canada.

Libtayo 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.¹ By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation.

CSCC is the second most common form of skin cancer that develops in squamous skin cells that make up the outer (epidermis) layers of the skin.² The majority of CSCCs are usually found on areas of the body exposed to UV rays such as the face, neck and the backs of the hands.

CSCC is classified as high-risk based on its risk of coming back – such as extent or type of lymph node involvement, and other non-nodal features such as nerve involvement, bone involvement, or recurrence at prior site of surgery.

Health Canada approval of Libtayo for high risk CSCC is based on C-POST, an international, phase 3, randomized trial comparing adjuvant cemiplimab with placebo in patients at high risk for recurrence of CSCC after surgery and postoperative radio­therapy. The primary endpoint was disease-free survival, and secondary endpoints included freedom from locoregional recurrence, freedom from distant recurrence, and safety.

In C-POST, a total of 415 patients were assigned to cemiplimab (n=209) or placebo (n=206). With a median follow-up of 24 months, efficacy results for cemiplimab compared to placebo showed a 68% reduction in the risk of disease recurrence or death (24 vs. 65 events; Hazard Ratio: 0.32; 95% Confidence Interval [CI]: 0.20 to 0.51; P<0.0001).³

The safety profile of Libtayo as adjuvant treatment of patients with CSCC at high risk of recurrence after surgery and radiation is consistent with the known safety profile for Libtayo monotherapy in advanced cancers. In the trial, the most common adverse events with cemiplimab (≥ 15%) were: fatigue (All Grades: 22.0%, Grade 3+: 0.5%), diarrhea (All Grades: 15.6%, Grade 3+: 1.5%), pruritus (All Grades: 16.1%, Grade 3+: 0.5%) and rash (All Grades: 16.1%, Grade 3+: 0.5%). AEs led to permanent discontinuation of treatment in 9.8% of patients. Two patients in each arm experienced an AE leading to death.

Indications in Canada
In Canada, in addition to the newly approved indication for adjuvant treatment of adult patients with CSCC at high risk of recurrence after surgery and radiation, Libtayo is indicated:

• For treatment of adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation.
• For the adjuvant treatment of adult patients with CSCC at high risk of recurrence after surgery and radiation.
• For treatment of adults with locally advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor.
• As monotherapy for first-line treatment of adults with non-small cell lung cancer (NSCLC) expressing PD-L1 in ≥ 50% of tumour cells (Tumour Proportion Score [TPS] ≥ 50%), as determined by a validated test, with no EGFR, ALK or ROS1 aberrations, who have locally advanced NSCLC who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC.
• In combination with platinum‐based chemotherapy for first‐line treatment of adults 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 treatment of adults with 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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¹ 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.

² Save Your Skin Foundation. Skin cancers. Accessed April 28, 2026.

³ Rischin et al. Adjuvant Cemiplimab or Placebo in High-Risk Cutaneous Squamous-Cell Carcinoma. N Engl J Med 2025;393:774-785.

SOURCE Regeneron Canada

Media Relations, Mariana Musaian, Tel: [phone], [email protected]