The US FDA has approved cosibelimab, a programmed death ligand-1 (PD-L1) blocking antibody, to treat adults with metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC) who are not candidates for curative surgery or radiation therapy. Cosibelimab facilitates anti-tumor immune response by binding to PD-L1 and induces antibody-dependent cell-mediated cytotoxicity. Clinical evidence The safety and efficacy of cosibelimab were evaluated in a clinical trial involving 109 mCSCC or laCSCC patients. The drug demonstrated clinically meaningful objective response rates (ORR) with durable responses in patients.
Notably, 47% of patients with mCSCC (n=78) and 48% with laCSCC (n=31) achieved ORR. The median duration of response was not reached in patients with mCSCC and 17.7 months in patients with laCSCC. Dosage and administration 1,200 mg intravenous infusion over 60…