Long term survival data for Opdivo (nivolumab) in treatment of renal cell carcinoma.- BMS
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]).>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%.
Related news and insights
Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), announced that Health Canada has approved Ferriprox (deferiprone) for the treatment of iron overload in patients with sickle cell disease (SCD) or other anemias.
The Menarini Group and Radius Health announced positive topline results from the phase III EMERALD study evaluating RAD 1901 (elacestrant) as a monotherapy versus the standard of care (SoC) for the treatment of ER+/HER2- advanced or metastatic breast cancer (mBC).
Gilead Sciences, Inc. announced the FDA approved a new low-dose tablet dosage form of Biktarvy (bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg tablets) for pediatric patients weighing at least 14 kg to less than 25 kg who are virologically suppressed or new to antiretroviral therapy.