Multinational phase 2 trial of sacituzumab govitecan for advanced urothelial carcinoma after chemotherapy and a checkpoint inhibitor

Sacituzumab govitecan (SG) is a Trop-2-directed antibody-drug conjugate. SG received accelerated FDA approval for the treatment of locally advanced or metastatic urothelial carcinoma previously treated with platinum-based chemotherapy and a checkpoint inhibitor, based on results of cohort 1 of the multinational phase 2 TROPHY-U-01 study. Updated results of the cohort showed that at a median follow-up of 10.5 months, the ORR was 28% (95% CI 20.2-37.6) while median PFS was 5.4 months (3.5-6.9) and median OS was 10.9 months (8.9-13.8). Safety data were consistent with the known SG toxicity profile. The incidence of adverse events varied across UGT1A1 mutation status subgroups; however, discontinuation rates remained relatively low for all groups. The authors conclude that with longer follow-up the response rate to SG remained high in patients with heavily pretreated locally advanced or metastatic urothelial carcinoma.