Dr. Choueiri on the Follow-Up Analysis 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 30-month follow-up analysis of the phase 3 KEYNOTE-564 trial (NCT03142334) in renal cell carcinoma (RCC).

The initial analysis of KEYNOTE-564, which was done with 24 months of follow-up, showed that adjuvant treatment with pembrolizumab (Keytruda) following nephrectomy led to a statistically significant improvement in disease-free survival (DFS) vs placebo in patients with RCC who were at intermediate- or high-risk for recurrence.

With 6 additional months of follow-up, pembrolizumab continued to demonstrate a clear improvement in DFS, Choueiri says. The 24-month HR for DFS of 0.68 dropped to 0.63 at 30 months, Choueiri explains. Additionally, results were consistent across all patient subgroups, Choueiri notes.

Furthermore, the HR for overall survival (OS) continued to favor pembrolizumab, shifting from 0.54 to point 0.52, Choueiri continues. Additional follow-up is planned for OS, which is a key secondary end point.