Merck announced results from the Phase 3 KEYNOTE-564 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

These late-breaking data are being presented during an oral session for the first time today at the 2024 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium (abstract #LBA359) and are included in the official ASCO GU Press Program.

“For patients with renal cell carcinoma, up to 40% may experience recurrence following surgery, at which point there is a significantly lower chance of survival,” said Dr. Toni K. Choueiri, director, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute and Jerome and Nancy Kohlberg professor of medicine, Harvard Medical School. “Results from KEYNOTE-564 show that pembrolizumab as adjuvant therapy significantly improved overall survival by 38% compared to placebo, becoming the first ever Phase 3 adjuvant trial to show improved survival for renal cancer patients at risk of recurrence after surgery.”

“The positive overall survival results from KEYNOTE-564 build upon the disease-free survival data, which supported approvals of KEYTRUDA for this indication worldwide,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “This is the second KEYTRUDA study to demonstrate a significant overall survival benefit in an earlier stage of cancer, and these new results add to the progress we’re making in earlier stages of disease.”

As previously reported, at an earlier pre-specified interim analysis with a median follow-up of 24.1 months, KEYNOTE-564 met its primary endpoint of disease-free survival (DFS), reducing the risk of disease recurrence or death by 32%.