Dr Rini on the OPTIC RCC Trial in Advanced Kidney Cancer

Brian I. Rini, MD, FASCO, Ingram professor of medicine, Division of Hematology Oncology, chief of Clinical Trials, Vanderbilt-Ingram University Cancer Center, discusses efforts to utilize genetic testing to improve treatment selection in renal cell carcinoma (RCC) through the phase 2 OPTIC RCC trial (NCT05361720).

There is a significant unmet need for biomarker-based treatments in RCC, Rini begins. Efforts are ongoing to develop more effective targeted therapeutics in this space, as well as to identify clinically useful biomarkers that can help guide treatment selection in the frontline and beyond.

The OPTIC RCC study was designed to better understand if genetic testing of tumor tissue would help improve prediction of patient benefit with currently approved regimens in advanced RCC, Rini explains. These FDA-approved regimens typically fall into 2 categories: immunotherapy doublets, such as the PD-L1 inhibitors nivolumab (Opdivo) and ipilimumab (Yervoy), or targeted therapies, such as the multikinase TKI cabozantinib (Cabometyx).

In this randomized, multicenter trial, tissue samples will be obtained from patients with newly diagnosed RCC, Rini reports. Analysis of the tumor tissue through RNA sequencing reveals the expression of angiogenesis- or immune-related genes, and are biologically classified as either angiogenic or immune inflammatory clusters, he explains. Patients with angiogenic clusters are then treated with a standard combination of cabozantinib and nivolumab. Conversely, immune inflammatory cluster patients will receive ipilimumab and nivolumab, Rini states. Additionally, the primary end point of the trial is objective response rate according to RECIST v1.1 criteria.

Investigators hypothesized that the identification of a tumor's genetic makeup will help match patients with their optimal treatment approach, Rini says. This trial represents an important step towards treating patients with RCC according to disease biology rather than relying on clinical factors, clinician bias, or other less personalized methods, he emphasizes. The trial is ongoing, and is currently accruing patients, Rini concludes.