FDA Approval Insights: Adjuvant Pembrolizumab in RCC

Welcome to OncLive On Air^®! I’m your host today, Jessica Hergert.

OncLive On Air^® is a podcast from OncLive^®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive^® covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, we had the pleasure of speaking with Toni K. Choueiri, MD, director of the Lank Center for Genitourinary Oncology, director of the Kidney Cancer Center, and senior physician at Dana-Farber Cancer Institute, and the Jerome and Nancy Kohlberg Chair and Professor of Medicine at Harvard Medical School, to discuss the FDA approval of adjuvant pembrolizumab (Keytruda) in renal cell carcinoma (RCC).

On November 17, 2021, the FDA approved pembrolizumab as therapy for the 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 based on 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 (HR 0.68; 95% CI, 0.53-0.87; P = .0010).

The median duration of exposure to pembrolizumab was 11.1 months (range, 1 day to 14.3 months). Additional data showed that the 24-month disease-free survival rate with pembrolizumab was 77% (95% CI, 73%-81%) vs 68% (95% CI, 64%-72%) with placebo.

In terms of safety, 20% of patients who received pembrolizumab experienced serious adverse reactions, including acute kidney injury (1.0%), adrenal insufficiency (1.0%), pneumonia (1.0%), colitis (1.0%), and diabetic ketoacidosis (1.0%). Moreover, 0.2% of patients who received pembrolizumab experienced fatal adverse reactions; this included 1 case of pneumonia.

Twenty-one percent of patients discontinued pembrolizumab because of toxicity, the most common of which was increased alanine aminotransferase (ALT; 1.6%), followed by colitis (1.0%), and adrenal insufficiency (1.0%).

Additionally, 26% of patients required dose interruptions of the immunotherapy because of an adverse effect such as increased aspartate aminotransferase (2.3%), arthralgia (1.6%), hypothyroidism (1.6%), diarrhea (1.4%), increased ALT (1.4%), fatigue (1.4%), rash (1.0%), decreased appetite (1.0%), and vomiting (1.0%).

In our exclusive interview, Choueiri discussed the significance of the FDA approval of pembrolizumab as adjuvant therapy in RCC and key data from the pivotal phase 3 KEYNOTE-564 trial.

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