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Long term survival data for Opdivo (nivolumab) in treatment of renal cell carcinoma.- BMS

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Last updated:7th Jun 2016
Published:7th Jun 2016
Source: Pharmawand

BMS announced new long-term overall survival (OS) results from two dose-ranging studies, the Phase 1 CA209-003 study and the Phase II CA209-010 study, evaluating Opdivo (nivolumab) in patients with previously treated advanced renal cell carcinoma (RCC). Findings include the first report of four- and five-year survival data from the advanced RCC cohort (n=34) of study -003, in which OS was an exploratory endpoint.

In study -003, 38% of patients were alive at four years, and 34% of patients were alive at five years. In study -010 (n=167), in which OS was a secondary endpoint, 29% of patients were alive at four years. The long-term safety profile of Opdivo in studies -003 and -010 was consistent with previously reported studies, with no new safety signals identified after more than four years of follow-up.

BMS is also presenting additional analyses of health-related quality of life data, a secondary endpoint, from the pivotal, Phase III study, CheckMate -025, which evaluated Opdivo versus everolimus in patients with advanced RCC who received prior anti-angiogenic therapy. In this study, 55.4% of patients treated with Opdivo experienced a clinically meaningful improvement in disease-related symptoms, as defined in the study, versus 36.7% of patients treated with everolimus (HR=1.66 [95% CI: 1.33-2.08; p<0.001]).>

Comment: Dr. Bernard Escudier, Chair of the Genitourinary Oncology Committee, Institut Gustave Roussy in Villejuif, France, commented, �Historically, five-year survival rates for patients diagnosed with advanced kidney cancer have been less than 12%.

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