In February 2021, the FDA approved a new indication for Libtayo (cemiplimab; from Regeneron/sanofi-aventis), a PD-1 inhibitor, for the treatment of patients with locally advanced or metastatic (spreading) basal-cell carcinoma, a type of skin cancer, who had received a hedgehog inhibitor or are not eligible for that type of drug.
Libtayo was previously approved by the FDA for patients with metastatic or locally advanced cutaneous squamous-cell carcinoma, a different type of skin cancer.
This new FDA approval was based on results from Study 1620 of 84 patients with locally advanced basal-cell carcinoma and 28 patients with metastatic basal-cell carcinoma.
The objective response rate was 29% in patients with locally advanced basal-cell carcinoma, and 79% of the patients maintained their response for 6 months or longer. Among the patients with metastatic basal-cell carcinoma, the objective response rate was 21%; all the responders maintained their response for 6 months or longer.
The most common side effects were fatigue, musculoskeletal pain, diarrhea, rash, and pruritus. Severe adverse reactions included pneumonitis, hepatitis, colitis, adrenal insufficiency, hypothyroidism and hyperthyroidism, diabetes, and nephritis.