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

Area of Science:

• Oncology
• Immunotherapy
• Clinical Trials

Background:

• Immune checkpoint inhibitors (ICIs) are a standard treatment for advanced genitourinary cancers.
• Understanding subsequent therapy use is crucial for optimizing patient outcomes.

Purpose of the Study:

• To evaluate the utilization of ICIs as subsequent therapy in patients from phase III cancer immunotherapy trials.
• To assess the consistency of ICI use in control arms after disease progression.

Main Methods:

• Analysis of 11 registrational phase III immunotherapy trials with overall survival benefit.
• Evaluation of subsequent therapy patterns in control-arm patients with renal cell carcinoma and urothelial carcinoma.

Main Results:

• In renal cell carcinoma (n=5135), ~60% of control patients received subsequent therapy, with 70% of those receiving an ICI.
• In urothelial carcinoma (n=3445), 54% of control patients received subsequent therapy, with 69% of those receiving an ICI.

Conclusions:

• Control-arm patients in these trials did not consistently receive ICIs upon progression.
• Further research is needed to understand the impact of subsequent therapy access on overall survival and identify factors influencing inconsistent provision.