Dr. Choueiri on the Use of Adjuvant Pembrolizumab 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 use of adjuvant pembrolizumab (Keytruda) in renal cell carcinoma (RCC).

The phase 3 KEYNOTE-564 trial (NCT03142334) evaluated the safety and efficacy of adjuvant pembrolizumab vs placebo in the treatment of patients with RCC following nephrectomy. In November 2021, the FDA approved adjuvant pembrolizumab as a treatment for patients RCC who are at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions, based on findings from the trial.

In a post-hoc analysis of KEYNOTE-564, investigators evaluated distant metastasis-free survival, time to second progression, and time to first subsequent treatment, Choueiri explains. At a median time from randomization to data cutoff of 30.1 months, all 3 end points displayed a statistically significant and clinically meaningful difference with pembrolizumab compared with placebo, Choueiri explains.

Based on data from the post-hoc analysis and the initial benefit observed from the trial’s primary end point of disease-free survival, the findings affirmed the clinical benefit of adjuvant pembrolizumab and supported its use after nephrectomy as a standard of care, Choueiri concludes.