ASCO 2019: Cemiplimab-rwlc for Locally Advanced Cutaneous Squamous Cell Carcinoma
Posted: Monday, June 3, 2019
The PD-1–blocking antibody cemiplimab-rwlc demonstrated durable antitumor activity in patients with locally advanced cutaneous squamous cell carcinoma, according to a primary analysis of a new phase II cohort. A previous phase II cohort had demonstrated similar results in patients with metastatic cutaneous squamous cell carcinoma. These results were presented during the 2019 American Society for Clinical Oncology (ASCO) Annual Meeting (Abstract 6015) by Michael Robert Midgen, MD, of MD Anderson Cancer Center, and colleagues.
“These data support the recent FDA approval of cemiplimab-rwlc for patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation,” wrote the authors.
The study included 78 patients, 59 male and 19 female, with a median age of 74. Patients had locally advanced cutaneous squamous cell carcinoma; 15% had received previous systemic therapy, and 55% had received radiotherapy. Patients received cemiplimab-rwlc intravenously, and their tumors were measured every 8 weeks.
At the cutoff date of October 10, 2018, the median follow-up was 9.3 months. The objective response rate to cemiplimab-rwlc was 44% (complete response rate, 13%; partial response rate, 31%) as assessed by an independent review. Some secondary endpoints—median duration of response, progression-free survival, and overall survival—could not be determined at this time because the longest duration of response (24 months) was still ongoing.
There was one treatment-related death of an unknown cause. Ten percent of patients experienced investigator-assessed grade 3 or higher immune-related adverse events. The most common adverse events reported with cemiplimab-rwlc were fatigue, diarrhea, and nausea.
Disclosure: The study authors’ disclosure information may be found at coi.asco.org.
