EC Approves Cemiplimab for Advanced or Metastatic BCC After HHI Therapy

Sharon Worcester

June 28, 2021

The European Commission (EC) has approved cemiplimab (Libtayo) for the treatment of adults with locally advanced or metastatic basal cell carcinoma (BCC) who progressed on — or could not tolerate — treatment with a hedgehog pathway inhibitor (HHI).

The programmed death-1 (PD-1) inhibitor, which is being jointly developed by Regeneron and Sanofi under a global collaboration agreement, was approved by the Food and Drug Administration for this indication in the United States in February; the FDA granted full approval for its use in patients with locally advanced BCC and accelerated approval for use in patients with metastatic BCC.

The EC’s thumbs-up for cemiplimab as a treatment for BCC marks the third such approval for an advanced cancer in the European Union: The immunotherapy was concurrently approved by the EC for the first-line treatment of adults with advanced non–small cell lung cancer (NSCLC) whose tumor cells have ≥ 50% PD-L1 expression and no EGFR, ALK or ROS1 aberrations, and was approved in 2019 for the treatment of adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation.

The FDA granted approval of cemiplimab for NSCLC in February, and for CSCC in 2018.

The latest BCC approval is based on data from an ongoing, open-label, prospective phase 2 clinical trial of 119 patients with advanced BCC who were previously treated with an HHI. The objective response rates in cemiplimab-treated patients were 32% (partial responses in 25%; complete responses in 7%) in those with locally advanced BCC, and 29% (partial responses in 26%; complete responses in 3%) in those with metastatic BCC.

About 90% of all patients had a duration of response (DOR) of 6 months or longer. Median DOR was not reached in either group at median follow-up of 16 months for locally advanced BCC and 9 months for metastatic BCC.

The safety profile of cemiplimab has been generally consistent across approved indications. Serious adverse events have been reported in 30% of 816 patients from all four cemiplimab monotherapy pivotal trials, and these led to permanent discontinuation of treatment in 8% of patients.

Immune-related adverse reactions occurred in 22% of patients, and led to permanent discontinuation in 4%. The most common such reactions were hypothyroidism (8%), hyperthyroidism (3%), pneumonitis (3%), hepatitis (2%), colitis (2%) and immune-related skin adverse reactions (2%).

Cemiplimab is administered by intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity. The recommended dose is 350 mg.

press release from Regeneron notes that research efforts with respect to cemiplimab — both as monotherapy and in combination with other agents — are focused on difficult-to-treat cancers, including advanced NSCLC, cervical cancer, and other solid tumors and blood cancers.

This article originally appeared on, part of the Medscape Professional Network.


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