Toni K Choueiri, Piotr Tomczak, Se Hoon Park, Balaji Venugopal, Tom Ferguson, Stefan N Symeonides, Jaroslav Hajek, Yen-Hwa Chang, Jae-Lyun Lee, Naveed Sarwar, Naomi B Haas, Howard Gurney, Piotr Sawrycki, Mauricio Mahave, Marine Gross-Goupil, Tian Zhang, John M Burke, Gurjyot Doshi, Bohuslav Melichar, Evgeniy Kopyltsov, Ajjai Alva, Stephane Oudard, Delphine Topart, Hans Hammers, Hiroshi Kitamura, David F McDermott, Adriano Silva, Eric Winquist, Jerry Cornell, Aymen Elfiky, Joseph E Burgents, Rodolfo F Perini, Thomas Powles
BACKGROUND: Adjuvant pembrolizumab therapy after surgery for renal-cell carcinoma was approved on the basis of a significant improvement in disease-free survival in the KEYNOTE-564 trial. Whether the results regarding overall survival from the third prespecified interim analysis of the trial would also favor pembrolizumab was uncertain. METHODS: In this phase 3, double-blind, placebo-controlled trial, we randomly assigned (in a 1:1 ratio) participants with clear-cell renal-cell carcinoma who had an increased risk of recurrence after surgery to receive pembrolizumab (at a dose of 200 mg) or placebo every 3 weeks for up to 17 cycles (approximately 1 year) or until recurrence, the occurrence of unacceptable toxic effects, or withdrawal of consent...
April 18, 2024: New England Journal of Medicine