This is an archive of papers published by the staff and faculty of Fox Chase Cancer Center. For questions about content, please contact Talbot Research Library
Last updated on
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
AbstractPURPOSE: 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.
Notes1527-7755 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.