New Indication: Sacituzumab Govitecan Alone for Muscle-Invasive Bladder Cancer

The SURE-01 trial evaluated neoadjuvant sacituzumab govitecan in patients with muscle-invasive bladder cancer. The study reported a ypT0N0 or ypT0Nx rate of 29.5% and a 24-month event-free survival rate of 71.4%. The safety profile of sacituzumab govitecan at a reduced dose of 7.5 mg/kg was manageable, with a substantial decrease in severe treatment-related adverse events compared to the initial 10 mg/kg dose.

Study

Phase II study [SURE-01, NCT05226117]

Muscle-invasive bladder cancer ineligible for or refusing neoadjuvant chemotherapy

Sacituzumab govitecan 10 or 7.5 mg/kg (n=44)

Efficacy

14 pts refused radical cystectomy (RC)

ypT0N0 rate after RC: 4 of 44 (9.1% [2.5-21.7])

ypT0N0-x rate after RC or reTUR-BT: 13 of 44 (29.5% [16.7-45.2])

24-mo EFS rate: 71.4% [58-87.8]

24-mo OS rate: 80.2% [67.7-95]

Safety

Grade >=3 AE: neutropenia (5.6% vs 75% at initial dose of 10 mg/kg), diarrhea (2.8% vs 50% at initial dose), abdominal pain (2.8%), creatinine increase (2.8%), mucositis (Not reported vs 12.5% at initial dose), sepsis/fever (2.8% vs 25% at initial dose)

Drug-related deaths: 0 vs 1 (12.5% at initial dose)