Dr Atkins on the Rationale of Investigating Nivolumab/Ipilimumab in RCC

Michael B. Atkins, MD, deputy director of Georgetown Lombardi Comprehensive Cancer Center, Scholl Professor, vice chair, the Department of Medical Oncology, Georgetown University Medical Center, discusses the rationale for launching the phase 2 HCRN GU16-260 trial (NCT03117309) in patients with advanced renal cell carcinoma (RCC).

This study evaluated the treatment of nivolumab (Opdivo) monotherapy for patients with treatment-naive metastatic kidney cancer, Atkins begins. Patients received nivolumab monotherapy in part A of the study, and if patients had a partial response or complete response to therapy, the patients continued nivolumab for up to 96 weeks, Atkins adds. If a patient had progressive disease, or stable disease at 48 weeks, they were eligible for salvage therapy with 4 cycles of nivolumab/ipilimumab (Yervoy) followed by nivolumab maintenance for up to 48 weeks, Atkins notes. Data from this study have been published in the Journal of Clinical Oncology, Atkins expands.

At the 2023 Genitourinary Cancers Symposium, investigators presented a correlative analysis from this trial, which evaluated treatment-free survival (TFS) in patients enrolled on the study, he explains. Immunotherapy can produce prolonged disease control after treatment cessation without the need for further anti-cancer therapy, but it can also produce treatment-related adverse effects (TRAEs) that can persist after treatment, Atkins emphasizes.

TFS can be used to characterize disease control and TRAEs, Atkins says. This has been done in patients with metastatic melanoma and kidney cancer. However, the issue with those analyses was that there was no formal end to the treatment, so patients could have continued therapy despite already obtaining maximum benefit, Atkins explains. Therefore, investigators evaluated data from the phase 2 HCRN GU16-260 trial, which was designed to reduce toxicity by limiting treatment exposure to CTLA-4 blockade in the second line and capping therapy at 96 weeks to provide a more realistic view of the potential utility of TFS, Atkins concludes.