Pembrolizumab Monotherapy for Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma: A Single-Arm Phase II Trial (KEYNOTE-629).

Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
Jean-Jacques GrobBrett G M Hughes

Abstract

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 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. 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 occu...Continue Reading

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Citations

Dec 10, 2020·International Journal of Molecular Sciences·Anja WesselyMarkus Vincent Heppt
Feb 16, 2021·Otolaryngologic Clinics of North America·Caitlin P McMullen, Thomas J Ow
Feb 20, 2021·Otolaryngologic Clinics of North America·Karen Y Choi, Cecelia E Schmalbach
Jan 22, 2021·Journal of the American Academy of Dermatology·Sophia Z ShalhoutDavid M Miller
Sep 28, 2020·Ophthalmology·Hakan DemirciFrancis Worden
Apr 4, 2021·Cancers·Yosuke IshitsukaManabu Fujimoto
Jun 8, 2021·Current Treatment Options in Oncology·Priyanka ReddyMonaliben Patel
Jun 9, 2021·Journal of Immunotherapy·Sophia Z ShalhoutDavid M Miller
Jul 2, 2021·Annals of Surgical Oncology·Flora YanAndrew T Day
Jul 23, 2021·Annals of Oncology : Official Journal of the European Society for Medical Oncology·B G M HughesJ-J Grob
Aug 6, 2021·Journal of Managed Care & Specialty Pharmacy·Eleanor PaulAndreas Kuznik
Jul 1, 2021·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Renata FerrarottoNeil D Gross
Aug 28, 2021·Current Oncology Reports·Sophia Z ShalhoutDavid M Miller

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Nov 3, 2021·Journal for Immunotherapy of Cancer·Shubham PantAung Naing

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