Dr. Plimack on Significance of CheckMate-025 Trial in RCC

Elizabeth Plimack, MD, director of Genitourinary Clinical Research at Fox Chase Cancer Center, discusses updated findings from the CheckMate-025 trial, which compared the efficacy of nivolumab (Opdivo) with everolimus (Afinitor) in patients with renal cell carcinoma (RCC).

The randomized study now has overall survival data (OS) at a median follow-up of 26 months for all patients, Plimack explains. What is interesting, she adds, is that there is a preserved OS benefit; at 2-years, 67% of patients in the nivolumab arm are alive. The curves continue to remain seperated, and there also appears to be a plateau. Of the patients who responded to nivolumab, 29% of them have maintained responses.

Results of this trial were also presented at the 2016 ASCO Annual Meeting, which showed that approximately one-third of patients with advanced RCC who were treated with single-agent nivolumab in the second-line setting or later were still alive at 4 and 5 years. This was found in long-term follow-up results of phase I and phase II clinical trials of the PD-1 inhibitor.

There are no new safety signals reported in the nivolumab arm. These findings show that nivolumab continues to "move the needle" in second-line RCC, she says.

However, there are still questions that remain with nivolumab, Plimack explains. It is unknown when it is best to administer the PD-L1 inhibitor, and how to give it in combination. What is known is that the goal of the therapy is durable response and disease control, so that patients do not need to remain on treatment for several years. When 10-year follow-up data are available, she adds, researchers will likely have more answers to these questions.

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