Yervoy plus Opdivo failed to meet the primary endpoint in localized renal cell carcinoma patients.
Bristol Myers Squibb announced results of the Phase 3 CheckMate -914 trial, testing the Opdivo (nivolumab) plus Yervoy (ipilimumab) combination as an adjuvant treatment in patients with localized renal cell carcinoma (RCC) who have undergone partial or complete removal of kidney and are at risk of reoccurrence. The combination failed to meet the primary endpoint of disease-free survival (DFS).
CheckMate -914 is a Phase 3, placebo-controlled trial. The trial has two parts - Part A evaluating the efficacy of Opdivo plus Yervoy combination, and Part B study in which Opdivo monotherapy is compared with placebo. In both parts, disease-free survival (DFS) was the primary endpoint.
Yearly, 431,000 new cases of renal cell carcinoma are diagnosed every year, and nearly 179,000 deaths are reported worldwide. The 5-year survival rate in patients with advanced, metastatic cancer is 14%.
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