ASCO 2019: Cemiplimab-rwlc in Metastatic Cutaneous Squamous Cell Carcinoma
Posted: Monday, June 10, 2019
Cemiplimab-rwlc demonstrated “substantial” antitumor activity and durable responses in patients with metastatic cutaneous squamous cell carcinoma, according to a phase II trial of the PD-1 monoclonal antibody. The study’s 12-month follow-up data were presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago (Abstract 9526).
“These data strongly support the recent U.S. Food and Drug Administration (FDA) approval of cemiplimab-rwlc for patients with metastatic cutaneous squamous cell carcinoma or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation,” stated Alexander David Guminski, MD, PhD, of the Royal North Shore Hospital, St Leonards, Australia, and colleagues.
A total of 59 patients with metastatic cutaneous squamous cell carcinoma received cemiplimab-rwlc at 3 mg/kg every 2 weeks. The overall response rate was 49.2% (n = 29), with 10 complete responses and 19 partial responses. The observed duration of response exceeded 12 months in 75.9% of patients who responded to therapy. The median overall survival has not yet been reached; the median progression-free survival was 18.4 months.
No new safety signals associated with cemiplimab-rwlc were reported in the follow-up data. The most common treatment-emergent adverse events were diarrhea (28.8%), fatigue (25.4%), and nausea (23.7%). By investigator assessment, grade ≥ 3 immune-related adverse events occurred in 13.6% of treated patients.
Disclosure: The study authors’ disclosure information may be found at coi.asco.org.
