{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,24]],"date-time":"2026-08-24T23:32:21Z","timestamp":1787614341723,"version":"build-2736575974"},"reference-count":29,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"29","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2024,10,10]]},"abstract":"<jats:sec>\n            <jats:title>PURPOSE<\/jats:title>\n            <jats:p>Sacituzumab govitecan (SG) is a Trop-2\u2013directed antibody-drug conjugate with an SN-38 payload, approved for patients with locally advanced (LA) or metastatic urothelial cancer (mUC) who progressed after platinum (PT)-based chemotherapy and a checkpoint inhibitor (CPI). Here, we report results from Cohort 2 of TROPHY-U-01 trial, evaluating the efficacy and safety of SG in patients with mUC.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>METHODS<\/jats:title>\n            <jats:p>\n              TROPHY-U-01 (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\/NCT03547973\">NCT03547973<\/jats:ext-link>\n              ) is a multicohort, open-label phase II study. Cohort 2 includes patients with LA or mUC who have had progression or recurrence after a CPI and were cisplatin-ineligible at study initiation. Patients received SG 10 mg\/kg on days 1 and 8 of 21-day cycles. The primary end point was objective response rate (ORR) per central review; secondary end points were clinical benefit rate (CBR), duration of response (DOR), and progression-free survival (PFS) per central review and safety.\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>RESULTS<\/jats:title>\n            <jats:p>Cohort 2 included 38 patients (61% male; median age 72.5 years; 66% visceral metastases [29% liver]; 50% received previous PT-based chemotherapy as previous [neo]adjuvant therapy]). At a median follow-up of 9.3 months, ORR was 32% (95% CI, 17.5 to 48.7), CBR 42% (95% CI, 26.3 to 59.2), median DOR 5.6 months (95% CI, 2.8 to 13.3), median PFS 5.6 months (95% CI, 4.1 to 8.3), and median overall survival 13.5 months (95% CI, 7.6 to 15.6). Grade \u22653 treatment-emergent adverse events occurred in 87% of patients, most commonly neutropenia (34%), anemia (24%), leukopenia (19%), fatigue (18%), and diarrhea (16%).<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>CONCLUSION<\/jats:title>\n            <jats:p>SG monotherapy demonstrated a relatively high ORR with rapid responses; this was feasible with a manageable toxicity profile in cisplatin-ineligible patients who had progression after CPI therapy. Limitations include a moderate sample size and lack of random assignment. These results warrant further evaluation of SG alone and in combinations in patients with LA\/mUC.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1200\/jco.23.01720","type":"journal-article","created":{"date-parts":[[2024,8,26]],"date-time":"2024-08-26T20:00:51Z","timestamp":1724702451000},"page":"3410-3420","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":25,"title":["TROPHY-U-01 Cohort 2: A Phase II Study of Sacituzumab Govitecan in Cisplatin-Ineligible Patients With Metastatic Urothelial Cancer Progressing After Previous Checkpoint Inhibitor Therapy"],"prefix":"10.1200","volume":"42","clinical-trial-number":[{"clinical-trial-number":"nct03547973","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6165-5797","authenticated-orcid":false,"given":"Daniel P.","family":"Petrylak","sequence":"first","affiliation":[{"name":"Yale School of Medicine, New Haven, CT"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2777-8587","authenticated-orcid":false,"given":"Scott T.","family":"Tagawa","sequence":"additional","affiliation":[{"name":"Weill Cornell Medical College of Cornell University, New York, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rohit K.","family":"Jain","sequence":"additional","affiliation":[{"name":"H. Lee Moffitt Cancer Center &amp; Research Institute, Tampa, FL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manojkumar","family":"Bupathi","sequence":"additional","affiliation":[{"name":"Rocky Mountain Cancer Centers, Littleton, CO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3949-5656","authenticated-orcid":false,"given":"Arjun","family":"Balar","sequence":"additional","affiliation":[{"name":"New York University Langone Medical Center, New York, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3701-5084","authenticated-orcid":false,"given":"Arash Rezazadeh","family":"Kalebasty","sequence":"additional","affiliation":[{"name":"University of California, Irvine, Orange, 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