Admin_Adham
The FDA has approved cemiplimab (Libtayo, Regeneron) for the adjuvant treatment of adults with cutaneous squamous cell carcinoma (CSCC) at a high risk for recurrence after surgery and radiation.
It’s the anti-PD-1 antibody’s fifth indication, with two prior approvals for non-small cell lung cancer as well as basal cell carcinoma and advanced or metastatic CSCC not eligible for curative surgery or radiation, an indication also carried by rivals pembrolizumab and cosibelimab.
The new approval makes cemiplimab the only immunotherapy approved for adjuvant CSCC, Regeneron said in a press release.
The approval was based on the C-POST trial involving 415 patients at a high risk for recurrence after surgery and radiation, with radiation completed within 10 weeks of study entry. Patients were randomly assigned in a 1:1 ratio to receive either cemiplimab monotherapy or placebo.
The estimated 24-month disease-free survival (DFS) was 87.1% with cemiplimab and 64.1% with placebo. Median DFS was 49.4 months in the placebo group but not reached in the cemiplimab group (hazard ratio, 0.32; P < .0001).
There were no new cemiplimab adverse events in C-POST. The most common side effects in 10% or more of patients were rash, pruritus, and hypothyroidism. Serious adverse events occurred in 18% of patients; those that occurred in 1% or more included pneumonia, rash, diarrhea, adrenal insufficiency, and arrhythmia, according to Regeneron.
The recommended dose is 350 mg intravenously every 3 weeks for 12 weeks, followed by 700 mg every 6 weeks or 350 mg every 3 weeks until disease recurrence or unacceptable toxicity or for up to 48 weeks.
Cemiplimab costs $10,679.40 for 350 mg/7 mL intravenous solution, according to drugs.com.
M. Alexander Otto is a physician assistant with a master’s degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape Medical News. Alex is also an MIT Knight Science Journalism fellow. Email: aotto@mdedge.com.
