Inclusion of patients with reduced performance status (ECOG 2 or higher) in FDA registrational trials for urothelial cancer.

680 Background: The Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) is a tool used to describe a cancer patient’s functional status and recruit participants into clinical trials. Clinical trials recruit patients with a good performance status (ECOG 0 or 1) which is not concordant with the real-world population. ASCO-Friends of Cancer Research in a joint statement has recommended the inclusion of patients with reduced PS in clinical trials. We evaluated the inclusion of patients with ECOG 2 or greater in urothelial cancer clinical trials leading to FDA approvals between 2014 and 2024. Methods: The US Food and Drug Administration (FDA) website was searched for all the drugs or drug combinations approved for the treatment of urothelial cancer in the last 10 years. We used identifiers like the drug name, trial name, and registration number to retrieve data on participant ECOG scores from public databases. The data was then tabulated and trends were analyzed. Results: The US FDA approved 16 drugs and combinations for the treatment of urothelial cancer from 2014-2024. The trials for these drugs enrolled a total of 5621 participants, of which only 107 (1.9%) belonged to ECOG PS 2 or more. ECOG data was not available for OLYMPUS trial. Only one of the trials included 3 participants with ECOG 3. Five trials did not have any participants belonging to ECOG 2 or higher. Most of the trials had percentage enrollment of ECOG 2 <10% except EV-201. Conclusions: Participants with ECOG 2 and greater have minimal enrolment in registrational clinical trials of urothelial cancer. This limits the options available for treatment of urothelial cancer in patients with reduced PS. Greater inclusion of poor PS patients is needed in future trials for greater health equity. Clinical trial Year Reduced PS% (ECOG 2 or higher) QUILT-3.0320 2024 3.5% BLC3001 2024 9.4% EV-302/KN-A39 2023 2.9% nadofaragene firadenovec-vncg 2022 2.5% CHECKMATE-274 2021 2.3% EV-201 2019 12.4% JNJ-42756493 2019 7.1% KEYNOTE-045 2017 1.1% CHECKMATE-901, EV-301, TROPHY, JAVELIN Bladder 100, KEYNOTE-057, durvalumab, atezolizumab 2016-2024 <1%