Opdivo (nivolumab) Plus Low-Dose Yervoy (ipilimumab) Demonstrates Continued Survival Benefit at 30-Month Follow-up in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carc
PRINCETON, N.J.---Bristol-Myers Squibb Company?(NYSE: BMY) today announced new results from the Phase 3 CheckMate -214 study, showing that therapy with?Opdivo(nivolumab) plus low-dose?Yervoy?(ipilimumab) continued to demonstrate long-term survival benefits in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC).
With a minimum follow-up of 30 months, intermediate- and poor-risk patients randomized to?Opdivo?plus low-dose?Yervoy?continued to show a significant overall survival (OS) benefit compared to those randomized to sunitinib. Additionally, at 30 months, the objective response rate (ORR) per investigator for intermediate- and poor-risk patients with?Opdivo?plus low-dose?Yervoy?improved compared to the previous analysis at a minimum of 17.5 months.
- OS: The 30-month OS rate for the intermediate- and poor-risk population was 60% for patients treated with?Opdivo?plus low-dose?Yervoy?versus 47% for patients treated with sunitinib [Hazard Ratio (HR) 0.66 (95% Confidence Interval [CI]: 0.54, 0.80); p<0.0001].
- ORR:?Opdivo?plus low-dose?Yervoy?was associated with a 42% ORR versus 29% with sunitinib (p=0.0001). More than half (52%) of the intermediate- and poor-risk patients who responded to?Opdivo?plus low-dose?Yervoy?had a response lasting at least 18 months versus 28% of the patients who responded to sunitinib.
- Complete Response (CR): The CR rate was 11% with?Opdivo?plus low-dose?Yervoy?versus 1% with sunitinib.
- OS: The 30-month OS rate for the ITT population was 64% for patients treated with?Opdivo?plus low-dose?Yervoy?versus 56% for patients treated with sunitinib [HR 0.71 (95% CI: 0.59, 0.86); p=0.0003].
- ORR: The ORR was 41% with?Opdivo?plus low-dose?Yervoy?versus 34% for sunitinib (p=0.015).
- CR: The CR rate was 11% with?Opdivo?plus low-dose?Yervoy?versus 2% with sunitinib.
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