Dr. Choueiri on the Design of KEYNOTE-564 in RCC

Toni Choueiri, MD, director, Lank Center for Genitourinary Oncology, director, Kidney Cancer Center, senior physician, Dana-Farber Cancer Institute, Jerome and Nancy Kohlberg Chair and Professor of Medicine, Harvard Medical School, discusses the design of the phase 3 KEYNOTE-564 trial (NCT03142334) in renal cell carcinoma (RCC).

Initial results at 24 months of follow-up for the KEYNOTE-564 trial were presented during the plenary session at the 2021 ASCO Annual Meeting. More recently, at the 2022 ASCO Genitourinary Cancer Symposium, updated 30-month results were shared.

The KEYNOTE-564 trial is large adjuvant study that enrolled 994 patients with intermediate- or high-risk clear cell RCC, Choueiri says. Patients were randomized to receive the PD-1 inhibitor pembrolizumab (Keytruda) or placebo for 1 year after undergoing nephrectomy with or without metastasectomy, Choueiri explains. The primary end point of the trial was investigator-assessed disease-free survival, Choueiri concludes.