(UroToday.com) The 2026 ASCO annual meeting featured a urothelial carcinoma session and a presentation by Dr. Brigida Maiorano discussing the final results and biomarker analyses of the SURE-01 trial assessing neoadjuvant sacituzumab govitecan in patients with muscle-invasive bladder cancer.
Standard of care for muscle-invasive bladder cancer is radical cystectomy with neoadjuvant chemotherapy, but ~50% of patients are ineligible for neoadjuvant chemotherapy, and 5-year survival for radical cystectomy alone is ≤50%. Sacituzumab govitecan is an antibody-drug conjugate composed of an anti-trophoblast cell surface antigen 2 (Trop-2) antibody coupled to SN-38 (a topoisomerase-I inhibitor). SURE-01 (NCT05226117) is a phase II trial testing neoadjuvant sacituzumab govitecan before radical cystectomy. Preliminary response rates suggested activity. At ASCO 2026, Dr. Maiorano and colleagues reported results of the primary analysis and final biomarker analyses of the SURE-01 trial.
Patients aged ≥18 years, ECOG performance status 0-1, with histologically confirmed cT2-T4aN0M0 muscle invasive bladder cancer, ineligible/refusing neoadjuvant chemotherapy, and scheduled for radical cystectomy received 4 cycles of sacituzumab govitecan 10 mg/kg on D1 and D8, every 3 weeks, followed by radical cystectomy. The primary outcome measure was the pathological complete response rate. Secondary endpoints included event-free survival (including relapse/progression, inability/unwillingness to undergo radical cystectomy in patients with residual disease, and death), overall survival, and safety. Transcriptome-wide analyses and comprehensive genomic profiling assays were performed on baseline tumor samples with Decipher Bladder.
From March 2022 to July 2025, 44 patients were treated and efficacy evaluable, with the following baseline characteristics:
After the initial 8 patients enrolled, the protocol was amended with a sacituzumab govitecan 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%) patients had a variant histology. Fourteen patients (31.8%) refused to undergo radical cystectomy and underwent a repeated TURBT. The median follow-up was 22 months (IQR 15-26). In the intention to treat population, the ypT0N0-x rate was 29.5% (95% CI 16.7-45.2):
Dr. Maiorano noted an enrichment of ypT0 responses in non-luminal subtypes (46% versus 14% of luminal), with the infiltrated luminal subtype having the highest proportion of ypT0 (62%). Variance by subtype revealed that TOP1 had the lowest scores in the infiltrated luminal subtype. A few signatures involving metabolism and tumor microenvironment were statistically significantly associated with a lower odds ratio of ypT0, whereas TROP2 expression (p = 0.72) was not:
The 24-month event-free survival rate was 71.4% (95% CI 58-87.8), and the 24-month overall survival rate was 80.2% (95% CI 67.7-95):
Longer event-free survival was observed for participants with lower TOP1-expressing tumors (p = 0.04).
Dr. Maiorano concluded her presentation discussing the final results and biomarker analyses of the SURE-01 trial assessing neoadjuvant sacituzumab govitecan in patients with muscle-invasive bladder cancer with the following take-home points:
- SURE-01 is the first to report results of an antibody-drug conjugate monotherapy targeting TROP2 in the neoadjuvant setting for patients with muscle-invasive bladder cancer
- Neoadjuvant sacituzumab govitecan at the reduced dose of 7.5 mg/kg demonstrated compelling activity and survival estimates, with a manageable safety profile, corroborating TROP2 as a suitable target for muscle-invasive bladder cancer
- Molecular biomarkers pointing to the payload were associated with neoadjuvant sacituzumab govitecan activity
Presented by: Brigida Maiorano, MD, PhD, Medical Oncologist, Department of Medical Oncology, IRCCS San Raffaele, Milan, Italy
Written by: Zachary Klaassen, MD, MSc – Urologic Oncologist, Associate Professor of Urology, Georgia Cancer Center, Wellstar MCG Health, @zklaassen_md on Twitter during the American Society of Clinical Oncology Genitourinary (ASCO) Annual Meeting held in Chicago, IL between May 29th and June 1st, 2026