Five-year follow-up of pembrolizumab plus chemotherapy for cervical cancer: exploratory analysis of KEYNOTE-826

In the multinational phase 3 KEYNOTE-826 trial, pembrolizumab (versus placebo) plus platinum-based chemotherapy, with or without bevacizumab, improved progression-free survival (PFS) and overall survival (OS) in participants with previously untreated, persistent, recurrent, or metastatic cervical cancer at the first interim analysis after a median follow-up of 22.0 months, with continued benefit at the analysis at median follow-up of 39.1 months. Five-year results of the trial have now been published. The trial included 617 participants from 151 centers in 19 countries. Participants received pembrolizumab 200 mg or placebo every 3 weeks for up to 45 cycles, with platinum based chemotherapy with or without bevacizumab. At five years, OS benefit with pembrolizumab was maintained. In the PD-L1 combined positive score of at least 1 population, the median OS was 28.6 versus 16.5 months (HR 0.62; 95% CI 0.50-0.76); and in the intention-to-treat population, the median OS was 26.4 versus 16.8 months (0.64; 0.53-0.78). The PFS advantage was similarly maintained. No new safety signals were observed. The authors conclude that in this exploratory analysis of KEYNOTE-826, the five-year data confirm the durability of benefit and reinforce pembrolizumab plus chemotherapy, with or without bevacizumab, as a standard-of-care first-line option for recurrent and metastatic cancer.