KEYNOTE-629: Pembrolizumab in Metastatic Cutaneous Squamous Cell Carcinoma
Posted: Friday, August 7, 2020
Pembrolizumab showed antitumor activity with durable responses in some patients with recurrent or metastatic cutaneous squamous cell carcinoma. According to Brett G.M. Hughes, BSc, MBBS, of the University of Brisbane, Australia, and colleagues, these findings, which were published in the Journal of Clinical Oncology, support the U.S. Food and Drug Administration’s approval of this immunotherapy for this patient population.
A total of 105 patients with recurrent or metastatic cutaneous squamous cell carcinoma that was not amenable to surgery or radiation were enrolled in this study. Patients received pembrolizumab every 3 weeks for 35 treatments or until disease progression, unacceptable toxicity, or withdrawal from the trial. Most patients (82.9%) had stage IV disease.
At a median follow-up of 11.4 months, the objective response rate was 34.3%, including 4 complete responses (3.8%) and 32 partial responses (30.5%). The median progression-free survival was 6.9 months, and the median overall survival was not yet reached. The disease control rate was estimated to be 52.4%, and 76.3% of patients saw a reduction in target lesion size compared with baseline. The median time to response was 1.5 months. For patients who had a response to therapy, 79.5% had an ongoing response at 6 months, and 65.6% had an ongoing response at 12 months or more.
On subgroup analysis, the overall response rate was 42.6% in patients whose primary tumors were located on their head or neck; the median progression-free survival for this group was 8.5 months. Patients with primary tumors located on other parts of the body had an objective response of 27.6%, with a progression-free survival of 4.2 months.
Treatment-related adverse events occurred in 66.7% of patients and were mostly mild or moderate. The most common adverse events of any grade were pruritus, asthenia, and fatigue.
Disclosure: For full list of author disclosures, visit ascopubs.org.
