Updated results from a Phase 2 clinical trial, EMPOWER-CSCC-1, evaluating Regeneron Pharmaceuticals (NASDAQ:REGN) and development partner Sanofi's (NASDAQ:SNY) Libtayo (cemiplimab-rwlc) in patients with locally advanced/metastatic cutaneous squamous cell carcinoma (CSCC) showed a response rate of 49% (n=29/59), including a 17% (n=10/59) complete response rate, in the metastatic group. The disease control rate (responders + stable cancer) was 63% (n=37/59). Median duration of response has net been reached.
On the safety front, the most common treatment-related adverse events in metastatic group were diarrhea (29%), fatigue (25%) and nausea (24%).
Serious or life-threatening immune-related adverse events occurred in 14% of patients.
The FDA approved the PD-1 inhibitor for CSCC in September 2018.
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