Libtayo Demonstrates Clinically Meaningful and Durable Responses in Advanced Basal Cell Carcinoma, Supporting Planned Regulatory Submission

Today, Regeneron and Sanofi announced the top-line data from a pivotal, single-arm, open-label clinical study of Libtayo, a PD-1 inhibitor co-developed by the two companies, for the treatment of patients with advanced basal cell carcinoma (BCC). In this patient population, which currently has no approved treatment options, Libtayo demonstrated clinically meaningful and durable responses. Regeneron and Sanofi plan to submit regulatory applications later this year.

Basal Cell CarcinomaBasal cell carcinoma is a type of skin cancer and one of the most common cancers worldwide. Although the vast majority of basal cell carcinomas can be detected early and are easily cured through surgery and radiation therapy, a small subset of tumors can progress to deeper structures and invade surrounding tissues, becoming more difficult to treat.

Libtayo is a fully humanized PD-1 monoclonal antibody jointly developed by Regeneron and Sanofi. It was approved by the U.S. FDA in 2018 for the treatment of advanced cutaneous squamous cell carcinoma (CSCC).

In this clinical trial, patients with locally advanced and metastatic basal cell carcinoma (BCC) were treated with Libtayo. These patients were either intolerant to Hedgehog pathway inhibitors or experienced disease progression after receiving such therapy. The objective response rate (ORR) achieved with Libtayo in patients with locally advanced disease was 29% (95% CI: 19%-40%), and 85% of patients who responded maintained their response for more than one year. The durable disease control rate (DCR), defined as response or stable disease lasting at least 6 months, was 60% (95% CI: 48%-70%).

In patients with metastatic disease (n=28), the ORR was 21% (95% CI: 8%-41%), and 83% of patients who achieved a response had a duration of response exceeding one year. The durable DCR was 46% (95% CI: 28%-66%).

“We are very encouraged by these clinically meaningful response rates and duration of response,” said Dr. Israel Lowy, Senior Vice President of Translational and Clinical Sciences in Oncology at Regeneron. “These data in advanced basal cell carcinoma represent the third example demonstrating that Libtayo can produce significant and clinically meaningful outcomes in patients with advanced cancers. Last week, Libtayo also showed a positive improvement in overall survival in a pivotal clinical trial for advanced non-small cell lung cancer, leading to the early termination of the trial.”

References:

[1] LIBTAYO® (CEMIPLIMAB) SHOWS CLINICALLY-MEANINGFUL AND DURABLE RESPONSES IN SECOND-LINE ADVANCED BASAL CELL CARCINOMA. Retrieved May 5, 2020, from https://investor.regeneron.com/news-releases/news-release-details/libtayor-cemiplimab-shows-clinically-meaningful-and-durable

Original Title: Regeneron/Sanofi PD-1 Inhibitor Shows Positive Clinical Results in Treating Basal Cell Carcinoma, Regulatory Submission Planned for This Year

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