Update on Cemiplimab in Advanced Cutaneous Squamous Cell Carcinoma
Posted: Friday, July 20, 2018
Cemiplimab appears to be safe and active in patients with advanced or metastatic cutaneous squamous cell carcinoma, according to final efficacy and safety data presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 9557). The results of this phase I study found that the anti–PD-1 monoclonal antibody “demonstrated a positive risk/benefit profile and produced substantial antitumor activity as well as durable responses,” concluded Taofeek Kunle Owonikoko, MD, PhD, of the Emory University School of Medicine, Atlanta, and colleagues.
In this expansion-cohort study, the investigators enrolled 10 patients with distantly metastatic and 16 patients with locally advanced cutaneous squamous cell carcinomas. Each patient received 3 mg/kg of cemiplimab by intravenous infusion for 30 minutes every 2 weeks, for up to 48 weeks. The median duration of cemiplimab exposure was 36 weeks.
The overall response rate was 50% among the 23 evaluable patients, with 0 complete responses and 13 partial responses. The disease control rate was 76.9%, and the durable disease control rate was 65.4%. Although the mediation duration of response was not reached for patients with a partial response, the duration of response was longer than 6 months in 7 patients and longer than 12 months in 2 patients.
Fatigue, which was the most common treatment-related adverse event of any grade, was reported in more than one-quarter of treated patients (26.9%). Grade 3 and greater treatment-related adverse events—asthenia, maculopapular rash, increased alanine aminotransferase, increased aspartate aminotransferase, adrenal insufficiency, and myalgia—occurred once.
