(Squamous Cell Carcinoma) Is Keytruda Effective?
Medical Supporter — Information Notice
This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of major Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
- 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.
[Important Note] Medical Supporter's translations of overseas clinical trial data and pharmaceutical information are not intended to encourage participation in clinical trials or use of new drugs. The translated information is for reference only and not intended as medication guidelines. Please discuss with healthcare professionals and refer to the original text below the article for accurate information.
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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