Multinational phase 4 trial of first-line pembrolizumab plus carboplatin and paclitaxel for recurrent/ metastatic head and neck squamous cell carcinoma

Standard-of-care first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) is pembrolizumab plus platinum and fluorouracil (FU). However, FU is associated with potential challenges (continuous 4-day infusion, high costs, and cardiovascular and gastrointestinal toxicities. The multinational phase 4 KEYNOTE-B10 trial evaluated first-line pembrolizumab plus carboplatin and paclitaxel for R/M HNSCC. Objective response rate was 49% (95% CI 38.4-58.7), with complete response in 7%. At one year, response was ongoing in 20.7%, while 12.1% were progression-free, and 52.3% were alive. Grade 3-5 treatment-related adverse events occurred in 75%, and serious treatment-related adverse events occurred in 27%. The authors conclude that pembrolizumab plus carboplatin and paclitaxel showed promising antitumor activity and a manageable safety profile in first-line R/M HNSCC.