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The FDA’s Oncologic Drugs Advisory Committee is poised to move forward this week with a public review of 6 indications for immune checkpoint inhibitors granted under the agency’s accelerated approval process that later failed to reach thresholds for statistical significance for key end points in confirmatory clinical trials.

Factors that oncologists need to consider when deciding whether to initiate single-agent therapy or a novel combination regimen as frontline treatment for patients with favorable-risk metastatic renal cell carcinoma.

Data from the phase 3 CheckMate-9ER trial has not only confirmed the advantage of cabozantinib plus nivolumab in terms of progression-free survival, overall survival, and responses vs sunitinib in the frontline treatment of patients with advanced renal cell carcinoma, but it has served as additional incentive to push the needle even further with research aimed at evaluating triplet regimens in the frontline setting and response-guided sequencing strategies.

Current treatment approaches that can be used to treat favorable-risk metastatic renal cell carcinoma in the first-line setting and implications for individualizing therapy despite guidance provided by the IMDC criteria.

Bradley A. McGregor, MD, of the Dana-Farber Cancer Institute, reacts to the emergence of new treatment gaps associated with novel combination regimens as first-line therapy for patients with metastatic renal cell carcinoma.