Dr Allaf on Perioperative Nivolumab Vs Observation Following Nephrectomy in RCC

Video

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.

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