![]() “These five-year results in renal cell carcinoma add to the evidence we have seen in several other tumor types of the unique role that Opdivo plus Yervoy-based combinations can play in changing survival outcomes for patients with cancer.” Now, with the longest follow-up for any Phase 3 trial of an immunotherapy combination in this disease, we’re seeing truly long-term survival benefits with Opdivo plus Yervoy,” said Dana Walker, M.D., M.S.C.E., vice president, development program lead, genitourinary cancers, Bristol Myers Squibb. “Four years ago, we presented the first results from CheckMate -214 during ESMO, which helped to transform the standard of care in advanced renal cell carcinoma. “While the median duration of response has not yet been reached with nivolumab plus ipilimumab, the data show some durable effects of this combination for patients living with this disease.” Motzer, M.D., CheckMate -214 investigator and Kidney Cancer Section Head, Genitourinary Oncology Service, Jack and Dorothy Byrne Chair in Clinical Oncology, Memorial Sloan Kettering Cancer Center. “The five-year data from the CheckMate -214 trial demonstrate that nearly half of patients lived longer after five years in this Phase 3 trial for advanced renal cell carcinoma,” said Robert J. These data were published online during the European Society for Medical Oncology (ESMO) Virtual Congress 2021 on September 16, 2021, 08:30 CEST (Abstract #661P). The safety profile of Opdivo plus Yervoy was manageable using established treatment algorithms, and no new safety signals emerged with extended follow-up. 2.4%).ĭOR: Median DOR was not reached with Opdivo plus Yervoy and was 24.8 months with sunitinib. Also, more patients treated with the combination achieved complete responses and subsequently did not progress (9.6% vs. 32%) and complete response rate than sunitinib (12% vs. ORR: Opdivo plus Yervoy continued to show a higher ORR (39% vs. Five-year OS rates were 48% for patients treated with the dual immunotherapy combination and 37% for those receiving sunitinib. OS: Opdivo plus Yervoy demonstrated 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). 2%).ĭuration of response (DOR): For patients treated with Opdivo plus Yervoy, median DOR was not reached, compared to 19.7 months with sunitinib.Īn analysis of all randomized patients, or the intent-to-treat (ITT) population (n=1,096), similarly showed long-term benefits with Opdivo plus Yervoy (n=550): In addition, more patients treated with the combination achieved complete responses (11% vs. ORR: ORR benefits were maintained with Opdivo plus Yervoy compared to sunitinib (42% vs. OS: The median OS was 47.0 months for intermediate- and poor-risk patients treated with Opdivo plus Yervoy versus 26.6 months with sunitinib (Hazard Ratio 0.68 95% Confidence Interval : 0.58 to 0.81), and five-year survival rates were 43% and 31%, respectively. 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: 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. ![]() ![]() 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). Opdivo plus Yervoy continued to show durable responses, with the median duration of response not reached among all randomized patients after five years of follow-upĭata to be presented at the European Society for Medical Oncology Virtual Congress 2021 Nearly half of patients treated with the dual immunotherapy combination were alive at five years from the start of therapy in CheckMate -214 trial ![]()
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