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Grob JJ , Gonzalez R , Basset-Seguin N , Vornicova O , Schachter J , Joshi A , Meyer N , Grange F , Piulats JM , Bauman JR , Zhang P , Gumuscu B , Swaby RF , Hughes BGM
Pembrolizumab Monotherapy for Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma: A Single-Arm Phase II Trial (KEYNOTE-629)
J Clin Oncol. 2020 Jul 16;38(25) :2916-2925
PMID: 32673170    PMCID: PMC7460151    URL: https://www.ncbi.nlm.nih.gov/pubmed/32673170
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PURPOSE: Treatment options are limited for patients with recurrent and/or metastatic (R/M) cutaneous squamous cell carcinoma (cSCC); mortality rates exceed 70% in patients with distant metastases. Here, we present the first interim analysis of the R/M cSCC cohort from the 2-cohort-locally advanced and R/M-phase II KEYNOTE-629 study. PATIENTS AND METHODS: Patients with R/M cSCC not amenable to surgery or radiation received pembrolizumab 200 mg every 3 weeks. The primary end point was objective response rate per RECIST v1.1. Secondary end points were duration of response, disease control rate, progression-free survival, overall survival, and safety. RESULTS: At data cutoff (April 8, 2019), median follow-up of 105 enrolled patients in the R/M cohort was 11.4 months (range, 0.4 to 16.3 months). Objective response rate was 34.3% (95% CI, 25.3% to 44.2%; 4 complete responses, 32 partial responses), and disease control rate was 52.4% (95% CI, 42.4% to 62.2%). Median duration of response was not reached (range, 2.7 to 13.1+ months; '+' refers to ongoing response at data cutoff). Median progression-free survival was 6.9 months (95% CI, 3.1 months to 8.5 months). Median overall survival was not reached (95% CI, 10.7 months to not reached). Treatment-related adverse events occurred in 66.7% of patients (n = 70), the most common of which were pruritus (n = 15; 14.3%), asthenia (n = 14; 13.3%), and fatigue (n = 13; 12.4%). Grade 3 to 5 treatment-related adverse events occurred in 5.7% (n = 6) of patients. One patient died of treatment-related cranial nerve neuropathy. CONCLUSION: Pembrolizumab demonstrated effective antitumor activity; clinically meaningful, durable responses; and acceptable safety in primarily elderly patients with R/M cSCC, supporting its use in clinical practice. Pembrolizumab adverse events in this study were consistent with its established safety profile.
1527-7755 Grob, Jean-Jacques Gonzalez, Rene Basset-Seguin, Nicole Vornicova, Olga Schachter, Jacob Joshi, Abhishek Meyer, Nicolas Grange, Florent Piulats, Josep M Bauman, Jessica R Zhang, Pingye Gumuscu, Burak Swaby, Ramona F Hughes, Brett G M Journal Article United States J Clin Oncol. 2020 Jul 16:JCO1903054. doi: 10.1200/JCO.19.03054.