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Mohamad Ezzeddine Allaf, MD, discusses the results of perioperative nivolumab vs observation in patients with renal cell carcinoma who undergo nephrectomy.
Mohamad Ezzeddine Allaf, MD, urologist-in-chief, Johns Hopkins Hospital, professor of Urology, Johns Hopkins Medicine, discusses the results of perioperative nivolumab (Opdivo) vs observation in patients with renal cell carcinoma (RCC) who undergo nephrectomy.
The phase 3 PROSPER trial (NCT03055013) compared nephrectomy with nivolumab vs the standard approach of nephrectomy plus post-operative follow-up and monitoring in patients with RCC.
Findings presented at the 2022 ESMO Congress showed that the study did not meet its primary end point of event-free survival (EFS), Allaf says. At a preplanned interim analysis, the hazard ratio for nivolumab vs observation was 0.96, Allaf continues, adding that the EFS curves remained similar at a median follow up of approximately 16 months.
The trial enrolled over 800 patients and had 3 preplanned futility analyses, based on the available information for follow-up events comprising recurrences and deaths, Allaf explains. At this planned interim analysis of inefficacy, approximately 71% of EFS events were available. The efficacy analysis was presented to the safety monitoring committee, which recommended the release of the results for futility, Allaf concludes.