Five-Year Data from CheckMate -214 Show Opdivo (nivolumab) Plus Yervoy (ipilimumab) Demonstrates Longest Median Overall Survival Currently Reported in Phase 3 Trial of Patients with Previousl
PRINCETON, N.J.--(BUSINESS WIRE)--?Bristol Myers Squibb?(NYSE: BMY) today announced that?Opdivo?(nivolumab) plus?Yervoy?(ipilimumab) continued to demonstrate durable, long-term survival in the Phase 3 CheckMate -214 trial, with a five-year survival rate of 48% in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC). After a median follow-up of 67.7 months,?Opdivo?plus?Yervoy?maintained superior overall survival (OS) and response benefits versus sunitinib in both patients with intermediate- and poor-risk prognostic factors, the primary endpoint population, and across all randomized patients.
In intermediate- and poor-risk patients (n=847),?Opdivo?plus?Yervoy?(n=425) maintained treatment effects over five years, with ongoing improvements in OS and overall response rate (ORR), two of the trial?s primary endpoints, as well as in supportive endpoints:
- OS: The median OS was 47.0 months for intermediate- and poor-risk patients treated withOpdivo?plus?Yervoyversus 26.6 months with sunitinib (Hazard Ratio [HR] 0.68; 95% Confidence Interval [CI]: 0.58 to 0.81), and five-year survival rates were 43% and 31%, respectively.
- ORR: ORR benefits were maintained with?Opdivoplus?Yervoy?compared to sunitinib (42% vs. 27%). In addition, more patients treated with the combinationachieved complete responses (11% vs. 2%).
- Duration of response (DOR): For patients treated with?Opdivoplus?Yervoy, median DOR was not reached, compared to 19.7 months with sunitinib.
- OS:?Opdivoplus?Yervoydemonstrated a median OS of 55.7 months in the ITT population, representing the longest survival outcome reported to date in a Phase 3 trial in advanced RCC, compared to 38.4 months with sunitinib (HR 0.72; 95% CI: 0.62 to 0.85). Five-year OS rates were 48% for patients treated with the dual immunotherapy combination and 37% for those receiving sunitinib.
- ORR:?Opdivoplus?Yervoy?continued to show a higher ORR (39% vs. 32%) and complete response rate than sunitinib (12% vs. 3%). Also, more patients treated with the combinationachieved complete responses and subsequently did not progress (9.6% vs. 2.4%).
- DOR: Median DOR was not reached with?Opdivoplus?Yervoy?and was 24.8 months with sunitinib.
- Patients who were alive three years after starting treatment with?Opdivo?plus?Yervoy?had an 81% probability of remaining alive for an additional two years, compared to 72% with sunitinib.
- Patients who were progression-free three years after starting treatment with the dual immunotherapy combination had an 89% probability of remaining progression-free for an additional two years, compared to 57% with sunitinib.
- Patients who responded to treatment with the combination and remained in response for three years had an 89% probability of remaining in response for two additional years vs. 63% with sunitinib.