ASCO 2019: Pembrolizumab for First-line Treatment of Unresectable Cutaneous Squamous Cell Carcinoma
Posted: Monday, June 17, 2019
Pembrolizumab as a first-line treatment provided a tumor response rate of 38.5% for older patients with unresectable cutaneous squamous cell carcinoma, according to the phase II CARSKIN study. The new results were presented at the 2019 American Society for Clinical Oncology (ASCO) Annual Meeting (Abstract 9547) by Eve Maubec, MD, PhD, of Hôpital Avicenne, and colleagues.
“First-line pembrolizumab provided robust antitumor activity regardless of PD-L1 expression levels,” wrote the authors.
The study included 39 patients at multiple institutions with unresectable cutaneous squamous cell carcinomas that were locally advanced (18%), regionally advanced (62%), or metastatic (21%). Patients were 79% male, with a median age of 79 years, and had not received prior chemotherapy. Researchers administered 200 mg of pembrolizumab intravenously every 3 weeks for up to 2 years. The primary endpoint was tumor response rate at 15 weeks, assessed by independent review. The authors also assessed safety and baseline PD-L1 expression.
After a median follow-up of 10.2 months, the response rate was 38 .5% in the intent-to-treat population: 2 complete responses and 13 partial responses. Fifteen patients were still on pembrolizumab as of the presentation. Centrally assessed baseline PD-L1 expression did not predict patient response at 15 weeks.
Of the 39 patients, 3 (8%) experienced severe treatment-related adverse events (one grade 3 cholestasis, one grade 3 colitis, and one death from recurrence of an unrelated head and neck cancer), and 4 patients (10%) discontinued treatment because of an adverse event. The authors indicated this safety profile is consistent with other pembrolizumab studies.
Disclosure: The study authors’ disclosure information may be found at coi.asco.org.
