In an Italian single-center phase II trial (SURE-02) reported in The Lancet Oncology, Necchi et al found that neoadjuvant sacituzumab govitecan-hziy plus perioperative pembrolizumab produced a “promising” clinical complete response rate in patients with muscle-invasive bladder cancer who were ineligible for or declined neoadjuvant cisplatin-based treatment.
Study Details
In the trial, 49 patients scheduled for radical cystectomy were enrolled at IRCCS San Raffaele Hospital, Milan, Italy, between October 2023 and February 2025. Patients received 4 cycles of pembrolizumab at 200 mg on day 1 and sacituzumab govitecan at 7.5 mg/kg on days 1 and 8 every 3 weeks followed by radical cystectomy or redo-transurethral resection of the bladder tumor (re-TURBT; after tumor board discussion for patients who declined to undergo radical cystectomy), and 13 cycles of adjuvant pembrolizumab at 200 mg every 3 weeks. The primary endpoint of the trial was clinical complete response rate, defined as negative imaging and no viable tumor at re-TURBT in patients not undergoing radical cystectomy.
Key Findings
Median follow-up was 14 months (interquartile range = 8–18 months). Clinical complete response was observed in 19 patients (39%, 95% confidence interval [CI] = 25%–54%), with all 19 undergoing re-TURBT. All patients with clinical complete response were metastasis-free, with two having intravesical relapse.
Grade 3 treatment-related adverse events occurred in 16% of patients, most commonly diarrhea (8%); no grade ≥ 4 treatment-related adverse events were observed. Serious treatment-related adverse events occurred in 6% of patients.
The investigators concluded: “Perioperative sacituzumab govitecan plus pembrolizumab revealed a promising clinical complete response rate, without the occurrence of grade 4 or higher adverse events, allowing a bladder preservation with sustained remission in approximately 40% of patients.”
Andrea Necchi, MD, of IRCCS San Raffaele Hospital, Comprehensive Cancer Center, Vita-Salute San Raffaele University, Milan, Italy, is the corresponding author for The Lancet Oncology article.
DISCLOSURE: The study was funded by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc., and Gilead Sciences. For full disclosures of the study authors, visit thelancet.com.
