(Squamous Cell Carcinoma) Is Keytruda Effective?

• September 28, 2020
• Read time: 2 minutes

On July 30, 2020, Eve Maubec published in the medical journal Journal of Clinical Oncology "Efficacy and safety validation of anti-PD-1 antibody pembrolizumab monotherapy in the CARSKIN Phase 2 clinical trial for patients with unresectable cutaneous squamous cell carcinoma."

The CARSKIN Phase 2 clinical trial administered pembrolizumab monotherapy (3-week cycle, 200 mg) to patients with unresectable cutaneous squamous cell carcinoma (N=57). The primary endpoint was objective response rate at 15 weeks, and secondary endpoints were overall survival, progression-free survival, and duration of response.

Trial results: In the cohort study of 39 patients, the primary endpoint objective response rate at 15 weeks was 41%, consisting of 13 partial responses and 3 complete responses. Stratified by PD-L1 expression, the objective response rate at 15 weeks was 55% for the positive group and 17% for the negative group.

Secondary endpoints at a median follow-up of 22.4 months: median overall survival was 25.3 months, median progression-free survival was 6.7 months, and median duration of response had not yet been reached. Regarding safety, the overall adverse event rate was 71%, with Grade 3 or higher adverse events at 7%.

Based on the CARSKIN clinical trial analysis results, Eve Maubec concluded: In patients with unresectable cutaneous squamous cell carcinoma, anti-PD-1 antibody pembrolizumab monotherapy demonstrated durable antitumor effects, and patient tolerability of adverse events was not a problem.

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Source: Phase II Study of Pembrolizumab As First-Line, Single-Drug Therapy for Patients With Unresectable Cutaneous Squamous Cell Carcinomas (J Clin Oncol. 2020 Jul 30;JCO1903357. doi: 10.1200/JCO.19.03357.)

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