Xin Gao, MD
Xin Gao, MD, of Harvard Medical School and Massachusetts General Hospital Cancer Center, commented on this study: “ARIES is a phase II study evaluating the anti–PD-L1 therapy avelumab in cisplatin-ineligible advanced urothelial cancer patients with a PD-L1 expression of at least 5% on tumor cells [by Ventana SP263 antibody]. Unfortunately, the study was not able to demonstrate an improvement in 1-year overall survival in this patient population. Nonetheless, we do see that avelumab is active in this patient population and can provide benefit as first-line therapy, with a subset of patients deriving deep responses and a 1-year overall survival of 41% in the entire PD-L1–high population.”
He continued: “Both pembrolizumab and atezolizumab already have regulatory approval as first-line therapy for cisplatin-ineligible patients with advanced urothelial cancer with high PD-L1 expression [using different immunohistochemistry assays and parameters]. Although avelumab has regulatory approval and is a standard of care in the maintenance and postplatinum chemotherapy settings, I do not think avelumab will displace the other therapies in the first-line cisplatin-ineligible patient population in the United States based on the ARIES data. Rather, the ARIES trial adds to the available data on the efficacy of anti–PD-1/L1 therapy in this population of patients and highlights the need for improved biomarkers beyond PD-L1 expression in advanced urothelial carcinoma.”
Dr. Gao noted that each of the immune checkpoint inhibitors has utilized different PD-L1 assays and cutoffs in respective studies. “I think improved biomarkers are certainly needed to better identify the patients who may benefit most from immune checkpoint inhibitors,” he stated.
DISCLOSURE: Dr. Gao has served as a consultant or advisor to Dendreon, Exelixis, Bayer, Guardant Health, and Flare Therapeutics; and has received institutional research funding from Aprea Therapeutics, Aravive, Arvinas, Exelixis, Harpoon Therapeutics, Janssen, Merck, Novartis, Pfizer, Poseida Therapeutics, Silverback Therapeutics, Takeda, and TopAlliance Biosciences.
