FDA Gives Thumbs Up to Sanofi-Regeneron Advanced BCC Treatment

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The U.S. Food and Drug Administration (FDA) has approved Regeneron and Sanofi’s PD-1 inhibitor Libtayo® (cemiplimab-rwlc), a fully-human monoclonal antibody, for the treatment of patients with advanced basal cell carcinoma (BCC) with a history of treatment with a hedgehog pathway inhibitor (HHI) or in patients with advanced BCC who are considered ineligible for an HHI.

Overall, the FDA granted full approval for patients with locally advanced BCC, while accelerated approval was granted for patients with metastatic BCC. Libtayo targets the immune checkpoint receptor PD-1 on T-cells and has been demonstrated to block cancer cells from utilizing the PD-1 pathway to suppress activation of T cells.

"Today's FDA approval of Libtayo will change the treatment paradigm for patients with advanced basal cell carcinoma," according to a statement made by Karl Lewis, M.D., Professor in the Division of Medical Oncology at the University of Colorado and a study researcher. "Advanced basal cell carcinoma is a persistent, painful and highly disfiguring cancer. While the primary systemic treatment options are hedgehog inhibitors, many patients will eventually progress on or become intolerant to this therapy. With Libtayo, these patients now have a new immunotherapy option that has demonstrated clinically meaningful and durable anti-tumor responses."

In May, Sanofi and Regeneron announced topline data from a Phase II trial showing Libtayo featured clinically meaningful and durable responses in patients with advanced BCC who have either progressed on or could not tolerate HHI.

Compared with other investigational agents, Libtayo represents the first therapy to demonstrate a clinical benefit in patients with advanced BCC following HHI therapy in a pivotal clinical trial.

Full approval of Libtayo in locally advanced BCC was based on a primary analysis of a clinical trial, while the accelerated approval of the drug in metastatic BCC was based on an interim analysis of another trial. Additional data from another trial that verify the therapy’s clinical benefit may contribute to future approval of the drug in metastatic BCC.

"With today's approval, Libtayo is now approved for both advanced cutaneous squamous cell and basal cell carcinomas, building a strong foundation in dermato-oncology," said Regeneron’s Israel Lowy, M.D., Ph.D., Senior Vice President, Translational and Clinical Sciences, Oncology, in a statement. "Beyond skin cancers, we also continue to investigate the potential of Libtayo in other difficult-to-treat cancers, starting with non-small cell lung cancer where an FDA decision is expected by the end of February."

The new approval is the second approval in line for Libtayo and was predominantly based on FDA Priority Review. This review process is used for treatments that would meet significant needs, if approved, in treating serious conditions safely and effectively. Libtayo was first approved in 2018 for the systemic treatment of adults with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC ineligible for curative radiation or curative surgery.

While Libtayo has been shown to be effective for the approved indications, research has suggested the treatment is associated with immune-mediated adverse reactions, which could be severe or fatal, in any organ system or tissue.

Sanofi’s Global Development Head, Oncology and Pediatric Innovation Peter Adamson said Sanofi and Regeneron plan to further develop Libtayo in other clinical trials and settings, such as a monotherapy and in combination with other therapeutic regimens.

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