BMS Reports Results of Opdivo (nivolumab) + Yervoy (ipilimumab) in P-III (CheckMate -901) Trial as 1L Treatment for Unresectable or Metastatic Urothelial Carcinoma

Shots:

The P-III (CheckMate -901) trial evaluates Opdivo (1mg/kg) + Yervoy (3mg/kg, q3w for 4 cycles) or Opdivo (480mg, q4w) + CT vs CT alone in 707 patients with untreated unresectable or metastatic UC who are ineligible for cisplatin-based CT
The trial failed to meet the 2EPs of OS in patients whose tumor cells express PD-L1 ≥1% at the final analysis, no new safety signals were identified. Following the IDMC’s recommendation, the trial continues to evaluate other 1EPs & 2EPs
The primary & sub-studies for the (CheckMate -901) trial are still ongoing & the company will provide additional results shortly. Opdivo + Yervoy showed improvements in OS in 6 P-III trials for NSCLC, MM, RCC, MPM & ESCC

Ref: BMS | Image: BMS