1752P Post hoc analysis of pembrolizumab efficacy in potentially platinum ineligible patients with urothelial carcinoma enrolled in KEYNOTE-052 and LEAP-011

First-line pembrolizumab monotherapy is a standard of care option in platinum-ineligible patients with advanced UC the US. However, there no definition platinum ineligibility; treatment decisions are based on clinical judgment. It interest to determine whether efficacy pembro varies criteria used define ineligibility. This post hoc analysis pooled pts treated from KEYNOTE-052 (N=370; NCT02335424) and LEAP-011 (N=242; NCT03898180) who were potentially ineligible determined by an extensive search literature. Candidate for ineligibility identified literature included ECOG PS 2, renal dysfunction (GFR <60 mL/min), visceral disease, age ≥80 y. Subgroups several combinations these selected this analysis: 2 (with or without y, dysfunction, disease); y dysfunction; disease dysfunction). Efficacy end points ORR OS. The database cutoffs September 26, 2020 (KEYNOTE-052), July 2021 (LEAP-011); median (range) follow-up was 56.3 mo (51.2-65.3) 7.0 (0.2-25.0), respectively. In primary analyses, (95% CI) 28.9% (24.3-33.8) (23.3-35.1) arm LEAP-011; OS 11.3 (9.7-13.1) 12.9 (9.8-17.8) mo, ranged 23.5%-33.3%, 9.0-10.6 among subgroups (Table).Table: 1752PAge + n=111ECOG only n=355ECOG n=87ECOG n=176ECOG n=285Visceral n=116Visceral n=307ORR, % CI)27.9 (19.8-37.2)26.2 (21.7-31.1)33.3 (23.6-44.3)27.8 (21.4-35.1)23.5 (18.7-28.9)26.7 (18.9-35.7)25.7 (20.9-31.0)OS, CI), months10.6 (6.8-12.3)10.1 (8.6-11.7)9.3 (6.3-12.2)10.1 (8.6-13.8)9.1 (7.2-10.8)9.0 (6.1-11.3)10.6 (9.0-12.5)12-month OS, %43.344.340.545.240.235.445.2 Open table new tab exploratory analysis, responses occurred regardless UC. Median generally consistent similar overall pt populations.