Sacituzumab Govitecan Withdrawn for aUC as Chemotherapy Boosts OS in TROPiCS-04

New findings from the phase 3 TROPiCS-04 study have revealed that chemotherapy provides better outcomes for patients with pretreated advanced urothelial carcinoma (aUC) than sacituzumab govitecan (SG), as the study’s primary endpoint of improved overall survival (OS) was not met.

In TROPiCS-04, a group of 711 patients who received prior platinum-based chemotherapy and checkpoint inhibitor therapy were randomized 1:1 to receive either SG 10 mg/kg intravenously (IV) on days 1 and 8 of 21- day cycles, or physician’s choice of chemotherapy (paclitaxel 175 mg/m² IV, docetaxel 75 mg/m² IV, or vinflunine 320 mg/m² IV) on day 1 of 21-day cycles.

SG was administered to 355 patients, yielding a median OS rate of 10.3 months (95% CI, 9.1-11.8), while 356 patients who were administered chemotherapy had a median OS rate of 9.0 months (95% CI, 7.5-9.7) (HR, 0.86; 95% CI, 0.73-1.02; P=.087).

The most common treatment-related adverse events (TRAEs) grade ≥3 with SG were neutropenia (35%; 12% febrile neutropenia) and diarrhea (15%). Grade 5 events occurred in 25 (7%) patients with SG and 7 (2%) patients with chemotherapy. TRAEs resulting in death occurred in 15 (4%) patients with SG, and in 5 (1%) patients with chemotherapy.

As SG did not demonstrate a significant improvement in OS over chemotherapy and resulted in a higher rate of adverse events leading to death, the indication for SG as a treatment for patients with pretreated aUC will be officially withdrawn by Gilead.