Dr. Choueiri on the FDA Approval of Adjuvant Pembrolizumab in RCC

Toni K. 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 FDA approval of adjuvant pembrolizumab (Keytruda) in renal cell carcinoma (RCC).

On November 18, 2021, the FDA approved pembrolizumab for the adjuvant treatment of patients with RCC who are at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

The regulatory decision was supported by findings from the phase 3 KEYNOTE-564 trial (NCT03142334), in which pembrolizumab led to a 32% reduction in the risk of disease recurrence or death vs placebo.

The approval represents a significant advancement for the treatment of this patient population as research in the field of RCC has tried to address the risk of recurrence after curative-intent treatment for many years, Choueiri says. Adjuvant pembrolizumab offers a natural next step to prevent RCC recurrences, Choueiri concludes.