WASHINGTON -- The on Friday for the treatment of advanced cutaneous squamous cell carcinoma (SCC), the second most common type of skin cancer.
"This type of cancer can be difficult to treat effectively when it is advanced and it is important that we continue to bring new treatment options to patients," Richard Pazdur, MD, director of the FDA's Oncology Center of Excellence, said in a statement.
Phase I/II results of the PD-1 inhibitor, delivered intravenously at a dose 3 mg/kg every 2 weeks, were published in the and presented at the American Society of Clinical Oncology meeting in June.
In a phase I expansion cohort of 26 cemiplimab-treated patients, 50% responded to the drug (95% CI 30%-70%); similarly, in a phase II study of 59 metastatic patients, 47% responded (95% CI 34%-61%) at a median of 7.9 months. Among responders, 57% had a duration of response ≥6 months -- over 80% were still responding at data cutoff.
"We're continuing to see a shift in oncology toward identifying and developing drugs aimed at a specific molecular target," said Pazdur. "With the Libtayo approval, the FDA has approved six immune checkpoint inhibitors targeting the PD-1/PD-L1 pathway for treating a variety of tumors, from bladder to head and neck cancer, and now advanced cutaneous SCC."
The side effect profile was reported to be similar to other PD-1/PD-L1 checkpoint inhibitors, with adverse events (AEs) occurring in ≥15% of metastatic cutaneous SCC patients treated with cemiplimab, and included constipation, diarrhea, fatigue, nausea, and rash. Treatment discontinuation due to AEs occurred in 7% of patients.
The FDA warned of infusion-related reactions and immune-mediated toxicities, including colitis, hepatitis, pneumonitis, endocrinopathies, and dermatologic and kidney problems.