FDA Grants Priority Review to Keytruda for Adjuvant Treatment of Early-Stage Renal Cell Carcinoma, Reducing Disease Progression Risk by 32%

On August 10, 2021, MSD announced that the U.S. FDA has granted Priority Review designation to its supplemental Biologics License Application (sBLA) for the blockbuster PD-1 antibody therapy Keytruda, as adjuvant therapy for patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following partial or radical nephrectomy. The PDUFA date for this application is December 10, 2021. This application is based on the positive results from the pivotal Phase 3 KEYNOTE-564 trial. Data presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting demonstrated that, compared with placebo, Keytruda yielded a statistically significant and clinically meaningful improvement in disease-free survival (DFS) in patients.

Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands PD-L1 and PD-L2, thereby activating T lymphocytes and enhancing the immune system's ability to detect and combat tumor cells. Currently, Keytruda has been approved in the United States, Europe, and Japan, in combination with axitinib, for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Results from the randomized, double-blind, Phase 3 KEYNOTE-564 trial showed that, at a median follow-up of 24.1 months, Keytruda reduced the risk of disease recurrence or death by 32% compared with placebo in patients with renal cell carcinoma who underwent surgical resection (HR=0.68, 95% CI, 0.53-0.87, p=0.0010). For overall survival, Keytruda was observed to reduce the risk of death by 46% (HR=0.54, 95% CI, 0.30–0.96, p=0.0164).

In 2020, there were over 431,000 newly diagnosed cases of kidney cancer worldwide, with more than 179,000 deaths attributable to the disease. Renal cell carcinoma (RCC) is the most common type of kidney cancer, accounting for approximately 90% of all cases, and its incidence in men is roughly twice that in women. The majority of RCC cases are incidentally detected during imaging studies performed for other abdominal conditions.

Dr. Scot Ebbinghaus, Vice President of Clinical Research at MSD Laboratories, said: “We look forward to working with the FDA as we strive to bring the first adjuvant immunotherapy to patients with renal cell carcinoma.”

References:

[1] FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for Keytruda® (pembrolizumab) as Adjuvant Therapy in Certain Patients With Renal Cell Carcinoma (RCC) Following Surgery. Retrieved August 10, 2021, from

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