FDA Approves Anti-PD-1 Antibody Cemiplimab for CSCC


On September 28, 2018, the U.S. FDA approved the anti-PD-1 antibody cemiplimab-rwlc (LIBTAYO) for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. The approval was based on the results from two clinical studies, phase I study 1423 trial and phase II study 1540 trial. The objective response rate (ORR) of CSCC patients who received cemiplimab (n=108) was 47.2% (95% CI, 37.5-57.1), with 3.7% complete and 43.5% partial response rates. Additionally, 31 patients (61%) had a duration of response (DoR) for 6 months or longer. In conclusion, cemiplimab-rwlc showed substantial activity and durable responses for patients with advanced CSCC.


N Engl J Med. 2018 Jul 26;379(4):341-351.

J Clin Oncol. 2018;36 (suppl; abstr 9519).