Dr Saliby on the Correlation Between Intermediate End Points and OS in RCC

Renee Saliby, MD, MSc, postdoctoral research fellow, Dana-Farber Cancer Institute, discusses the rationale for investigating the correlation between intermediate end points and overall survival (OS) in patients with metastatic renal cell carcinoma (RCC) treated with immune checkpoint inhibitors.

In recent years, the management of metastatic RCC has undergone significant changes, particularly with the introduction and widespread use of immune checkpoint inhibitors, Saliby begins. These advances have substantially improved OS rates for patients, with median OS now reaching up to 53 months, according to Saliby. However, these improvements have also introduced new challenges in clinical trial design and evaluation, she explains. Specifically, phase 3 confirmatory trials now require longer follow-up periods, more events to occur, and greater amounts of resources, Saliby notes. As a result, researchers are increasingly focusing on intermediate end points, which can provide earlier insights into trial outcomes and potentially predict long-term survival outcomes, Saliby notes.

To explore these intermediate end points and their relationship with OS, a retrospective study was conducted using data from the International Metastatic RCC Database Consortium, which tracks information on patients with metastatic RCC, Saliby continues. The study included patients who received immune checkpoint inhibitor–based therapies between 2013 and 2023. The primary intermediate end points were objective response rate, which was assessed by trained professionals; time to next treatment, defined as the interval between the start of the first and second lines of therapy; and time to treatment failure, which was defined as the duration from the initiation of the first therapy until it was discontinued, Saliby reports.

The study determined the association between these end points and OS, providing valuable insights that could help optimize treatment strategies and improve patient outcomes in the evolving metastatic RCC treatment paradigm, she states. The findings underscore the importance of early treatment response as a predictor of long-term survival, particularly in the context of immune checkpoint inhibitor–based therapies, Saliby concludes.