Keytruda demonstrated superior disease-free survival in KEYNOTE 564, compared with placebo as adjuvant therapy in patients with renal cell carcinoma following surgery.

Merck Inc., announced that the pivotal Phase III KEYNOTE-564 trial evaluating Keytruda, Merck’s anti-PD-1 therapy, met its primary endpoint of disease-free survival (DFS) for the potential adjuvant treatment of patients with renal cell carcinoma (RCC) following nephrectomy (surgical removal of a kidney) or following nephrectomy and resection of metastatic lesions Based on an interim analysis conducted by an independent Data Monitoring Committee, Keytruda monotherapy demonstrated a statistically significant and clinically meaningfully improvement in DFS compared with placebo. The trial will continue to evaluate overall survival (OS), a key secondary endpoint. The safety profile of Keytruda in this trial was consistent with that observed in previously reported studies. Results will be presented at an upcoming medical meeting and will be submitted to regulatory authorities. “Since its first approval in renal cell carcinoma nearly two years ago, Keytruda has become an important first-line treatment option in combination with axitinib for patients with advanced renal cell carcinoma,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “These new data are the result of our research to evaluate the role of Keytruda in helping patients with earlier stages of disease and are the first positive results for an anti-PD-1 therapy in the adjuvant treatment of patients with renal cell carcinoma. We look forward to sharing results of KEYNOTE-564 with the medical community and regulatory authorities as soon as possible.”