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FDA grants breakthrough therapy designation to cemiplimab for advanced cutaneous squamous cell carcinoma
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The FDA granted breakthrough therapy designation to cemiplimab for the treatment of adults with metastatic or locally advanced and unresectable cutaneous squamous cell carcinoma, according to the drug’s manufacturer.
The designation included preliminary data from the phase 1 REGN2810 trial designed to evaluate cemiplimab (REGN2810; Regeneron, Sanofi) — an investigational human, monoclonal antibody targeting PD-1 — which included two expansion cohorts involving 26 patients with advanced cutaneous squamous cell carcinoma (median follow-up, 6.9 months).
Patients treated with cemiplimab demonstrated an overall response rate of 46.2% — including two complete responses, nine partial responses and one unconfirmed partial response — and a disease control rate of 69.2%.
Median PFS and OS were not reached at the data cutoff.
Ten patients remained in response as of data cutoff.
Patients reported fatigue (23.1%) as the most common adverse event.
The most common severe adverse events included arthralgia, maculopapular rash, asthenia, aspartate aminotransferase elevation and alanine aminotransferase elevation (3.8% for each).
“Cutaneous squamous cell carcinoma is the second deadliest skin cancer after melanoma, according to the most recent data available,” Kyriakos P. Papadopoulos, MD, senior clinical investigator at South Texas Accelerated Research Therapeutics, said in a company-issued release. “There are limited treatments and no established standards of care for advanced stages of this disease. Cutaneous squamous cell carcinoma has one of the highest mutation rates reported for any cancers, likely contributing to the study findings, which represent a high responder rate to a PD-1 antibody in a solid tumor cancer. These results are promising and suggest the PD-1 pathway is an important therapeutic target in these patients.”
Cemiplimab is also under investigation in the pivotal, single-arm, open-label phase 2 EMPOWER-CSCC 1 trial, which is currently enrolling adults with metastatic or locally advanced and unresectable cutaneous squamous cell carcinoma.
The companies intend to submit a biologics license application for cemiplimab to the FDA next year.