What is the role of cemiplimab in the treatment of basal cell carcinoma?

Updated: Mar 23, 2021
  • Author: Robert S Bader, MD; Chief Editor: William D James, MD  more...
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Cemiplimab, a programmed death 1 (PD-1) inhibitor,  was the first immunotherapy approved by the FDA for advanced BCC after Hedgehog pathway inhibition. In 2021, it was fully approved for patients with locally advanced BCC and granted accelerated approval for patients with metastatic BCC (mBCC).

Approval for locally advanced BCC was based on a phase II, nonrandomized, open-label trial, Study 1620. Patients (n=112) with locally advanced or metastatic BCC (mBCC) whose BCC had progressed on HHI or who were not candidates for HHI therapy received cemiplimab until disease progression, unacceptable toxicity, or completion of planned treatment. The confirmed objective response rate was 29% (95% CI: 19, 40) for patients with locally advanced BCC and 21% (95% CI: 8, 41) for those with mBCC. Observed duration of response (DOR) for at least 6 months was reported in 79% of locally advanced BCC responders and all mBCC responders. For both treatment groups, median DOR was not reached. [102]

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