KEYTRUDA Is Now Approved as Monotherapy for Adults With RCC at Increased Risk of Recurrence Following Nephrectomy, or Following Nephrectomy and Resection of Metastatic Lesions
KEYTRUDA Is the First Immunotherapy Approved in Europe in the Adjuvant Setting for These Patients With RCC
Reno, Nevada (UroToday.com) — Merck, known as MSD outside the United States and Canada, announced that the European Commission has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the adjuvant treatment of adults with renal cell carcinoma (RCC) at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. This approval is based on results from the Phase 3 KEYNOTE-564 trial, in which KEYTRUDA demonstrated a statistically significant improvement in disease-free survival (DFS), reducing the risk of disease recurrence or death by 32% (HR=0.68 [95% CI, 0.53-0.87]; p=0.0010) after a median follow-up of 23.9 months compared to placebo, in patients at increased risk of recurrence (defined in the clinical trial protocol as intermediate-high or high risk following nephrectomy and those with resected advanced disease).