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Neoadjuvant Sacituzumab Govitecan in Patients With Muscle-Invasive Bladder Cancer: Primary Results of the SURE-01
Andrea Necchi1,2, Joep J de Jong3, Brigida A Maiorano1
1Department of Medical Oncology, IRCCS San Raffaele Hospital, Comprehensive Cancer Center, Milan, Italy.
Purpose:
To evaluate neoadjuvant sacituzumab govitecan (SG), followed by radical cystectomy (RC), in patients with muscle-invasive bladder cancer (MIBC) who are ineligible for/refuse neoadjuvant chemotherapy (NAC). We report the results of the primary analysis and biomarker analyses of the phase II SURE-01 trial (ClinicalTrials.gov identifier: NCT05226117).
Patients And Methods:
Patients were age 18 years and older, had Eastern Cooperative Oncology Group performance status 0-1, had histologically confirmed cT2-T4aN0M0 MIBC, were ineligible/refusing NAC, and were scheduled for RC received four cycles of SG 10 mg/kg on day 1 and day 8, once every 3 weeks, followed by RC. The primary outcome measure was the pathologic complete response (pT0N0) rate. Transcriptome-wide analyses and comprehensive genomic profiling assays were performed on baseline tumor samples.
Results:
From March 2022 to July 2025, 44 patients were treated and efficacy evaluable. After the initial eight patients enrolled, the protocol was amended with a SG dose of 7.5 mg/kg, with primary prophylaxis for neutropenia, due to the occurrence of two deaths (one treatment-related). Subsequent grade 3-4 treatment-related adverse-events occurred in 5 patients (13.9%). Twenty-six patients (59.1%) had a cT3-4 stage and 20 (45.5%) had a variant histology. Fourteen patients (31.8%) refused to undergo RC, accounting for 12 repeating a transurethral resection of the bladder tumor and two undergoing active surveillance. The median follow-up was 22 months (IQR, 15-26). In the intention-to-treat population, although the protocol-defined ypT0N0 rate was 9.1% (95% CI, 2.5 to 21.7), the overall ypT0N0-x rate was 29.5% (95% CI, 16.7 to 45.2), with an enrichment of ypT0 responses in nonluminal subtypes (46% v 14% of luminal). The 24-month event-free survival (EFS) rate was 71.4% (95% CI, 58 to 87.8), with longer EFS for participants with lower TOP1-expressing tumors.
Conclusion:
Neoadjuvant SG, at the reduced dose of 7.5 mg/kg, was active with a manageable safety profile, corroborating TROP2 as a suitable target for MIBC.
