Sanofi, Regeneron target US, EU filings for PD-1 inhibitor cemiplimab following positive mid-stage results

Sanofi and Regeneron Pharmaceuticals announced Wednesday top-line results from a Phase II study in which the experimental PD-1 inhibitor cemiplimab demonstrated an overall response rate of 46.3 percent in patients with advanced cutaneous squamous cell carcinoma (CSCC). The companies noted that the median duration of response had not yet been reached at the data cut-off point.

According to Sanofi and Regeneron, data from the trial will form the basis of a rolling biologics license application submission to the FDA, which is expected to be completed in the first quarter of 2018. The drugmakers added that a filing to the European Medicines Agency is also expected to be completed in the first quarter of 2018.

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The EMPOWER-CSCC 1 study is investigating several doses of cemiplimab in patients with CSCC, with subjects in one arm of the trial receiving a 3 mg/kg dose every two weeks. Sanofi and Regeneron noted that in the other two study arms, patients with metastatic CSCC receive a 350 mg flat dose of cemiplimab every three weeks, while patients with locally advanced and unresectable CSCC receive a 3 mg/kg dose of the drug every two weeks. The companies added that approximately two-thirds of patients had progressed after prior systemic chemotherapy or radiation.

The drugmakers indicated that the analysis included 82 patients, who had a minimum of six months of follow-up, with 32 of 38 responses ongoing. "For patients with CSCC that cannot be cured by surgery or radiation, there are no FDA-approved treatment options," remarked Israel Lowy, vice president of global clinical development at Regeneron. "The high and durable response rates seen in this study are particularly notable given that the study enrolled patients regardless of biomarker status," Lowy added.

Updated results from the trial will be submitted for presentation at a 2018 medical congress.

Cemiplimab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement signed in 2015. In September, the FDA awarded the drug breakthrough therapy designation in advanced CSCC.

Separately on Wednesday, Sanofi said that it plans to make nine regulatory submissions over the next 18 months, including a filing for cemiplimab. The company added that at least 10 pivotal Phase III studies will start in the next 12 months, including cemiplimab in first-line non-small-cell lung cancer.

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