Non-Immunotherapy Arm Allocations in Phase 3 Genitourinary Cancer Trials with Immunotherapy.

Overview

INTRODUCTION: Immune checkpoint inhibitors are a standard of care in managing locally advanced and metastatic genitourinary cancers. METHODS: We evaluated the utilization of immune checkpoint inhibitors as subsequent therapy in patients enrolled to 11 registrational phase III cancer immunotherapy trials that demonstrated an overall survival benefit. RESULTS: For renal cell carcinoma (n = 5135 patients, 2014-2019), approximately 60% of control-arm patients received subsequent therapy upon progression, with 70% of those receiving an immune checkpoint inhibitor. For urothelial carcinoma (n = 3445 patients, 2015-2022), 54% of control-arm patients received subsequent therapy upon progression, with 69% of those receiving an immune checkpoint inhibitor. CONCLUSION: Patients randomized to the control arm of these trials did not consistently receive immune checkpoint inhibitors upon progression. Further research is needed to understand how access to subsequent therapies impacts overall survival, and to identify factors associated with inconsistent provision of subsequent therapies.