{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,3]],"date-time":"2026-08-03T23:33:42Z","timestamp":1785800022433,"version":"3.56.0"},"reference-count":32,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"21","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["J Clin Oncol"],"published-print":{"date-parts":[[2026,7,20]]},"abstract":"<jats:sec>\n                    <jats:title>PURPOSE<\/jats:title>\n                    <jats:p>\n                      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:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT05226117\">NCT05226117<\/jats:ext-link>\n                      ).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>PATIENTS AND METHODS<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>\n                      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%\n                      <jats:italic toggle=\"yes\">v<\/jats:italic>\n                      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.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSION<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1200\/jco-26-00142","type":"journal-article","created":{"date-parts":[[2026,5,31]],"date-time":"2026-05-31T12:00:14Z","timestamp":1780228814000},"page":"2017-2028","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":1,"title":["Neoadjuvant Sacituzumab Govitecan in Patients With Muscle-Invasive Bladder Cancer: Primary Results of the SURE-01 Trial"],"prefix":"10.1200","volume":"44","clinical-trial-number":[{"clinical-trial-number":"nct05226117","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3007-2756","authenticated-orcid":false,"given":"Andrea","family":"Necchi","sequence":"first","affiliation":[{"name":"Department of Medical Oncology, IRCCS San Raffaele Hospital, Comprehensive Cancer Center, Milan, Italy"},{"name":"Vita-Salute San Raffaele University, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2378-367X","authenticated-orcid":false,"given":"Joep J.","family":"de Jong","sequence":"additional","affiliation":[{"name":"Department of Urology, Erasmus University Medical Center, Rotterdam, the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5423-3158","authenticated-orcid":false,"given":"Brigida A.","family":"Maiorano","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, IRCCS San Raffaele Hospital, Comprehensive Cancer Center, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James A.","family":"Proudfoot","sequence":"additional","affiliation":[{"name":"Veracyte Inc, San Francisco, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7227-7821","authenticated-orcid":false,"given":"Giuseppe","family":"Basile","sequence":"additional","affiliation":[{"name":"Department of Urology, IRCCS San Raffaele Hospital, Comprehensive Cancer Center, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-7109-2429","authenticated-orcid":false,"given":"Antonio","family":"Cigliola","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, IRCCS San Raffaele Hospital, Comprehensive Cancer Center, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1165-1776","authenticated-orcid":false,"given":"Chiara","family":"Mercinelli","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, IRCCS San Raffaele Hospital, Comprehensive Cancer Center, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1199-2338","authenticated-orcid":false,"given":"Valentina","family":"Tateo","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, IRCCS San Raffaele Hospital, Comprehensive Cancer Center, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michela","family":"Piacentini","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, IRCCS San Raffaele Hospital, Comprehensive Cancer Center, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3379-2644","authenticated-orcid":false,"given":"Emanuele","family":"Crupi","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, IRCCS San Raffaele Hospital, Comprehensive Cancer Center, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-7359-3112","authenticated-orcid":false,"given":"Giovanni L.","family":"Pastorino","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, IRCCS San Raffaele Hospital, Comprehensive Cancer Center, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-7884-9150","authenticated-orcid":false,"given":"Gaia","family":"Latini","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, IRCCS San Raffaele Hospital, Comprehensive Cancer Center, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Enrico","family":"Tomasi","sequence":"additional","affiliation":[{"name":"Pharmacy Unit, IRCCS San Raffaele Hospital, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elai","family":"Davicioni","sequence":"additional","affiliation":[{"name":"Veracyte Inc, San Francisco, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marco","family":"Moschini","sequence":"additional","affiliation":[{"name":"Department of Urology, IRCCS San Raffaele Hospital, Comprehensive Cancer Center, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9690-8624","authenticated-orcid":false,"given":"Giorgio","family":"Brembilla","sequence":"additional","affiliation":[{"name":"Department of Radiology, IRCCS San Raffaele Hospital, Comprehensive Cancer Center, Milan, 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