Multicenter phase 2 study of sacituzumab govitecan for metastatic urothelial cancer in cisplatin-ineligigble patients after checkpoint inhibitor therapy

Sacituzumab govitecan (SG) is a Trop-2 directed antibody-drug conjugate with a SN-38 payload. Cohort 2 of the multicenter phase 2 TROPHY-U-01 study evaluated SG for metastatic urothelial cancer (mUC) after progression on immune checkpoint inhibitor (ICI) therapy in cisplatin-ineligible patients. The patients received SG 10 mg/kg on days 1 and 8 of 21-day cycles. Primary endpoint was objective response rate per central review. The objective response rate was 32% (95% CI 17.5- 48.7) with clinical benefit in 42% of patients (26.3-59.2) and median duration of response 5.6 months (2.8-13.3). The median progression-free survival was 5.6 months (95% CI 4.1-8.3) and the median overall survival was 13.5 months (7.6-15.6). Grade ≥ 3 treatment-emergent adverse events occurred in 87% of patients. The authors conclude that SG monotherapy resulted in a relatively high ORR with rapid responses and a manageable toxicity profile among cisplatin-ineligible mUC patients after progression on ICI therapy.