title: Sacituzumab Govitecan, a Novel Antibody--Drug Conjugate, in Patients With Metastatic Platinum-Resistant Urothelial Carcinoma.
abstract: Patients with metastatic, platinum-resistant urothelial carcinoma (PRUC) have no Food and Drug Administration-approved therapies. The response rates to second-line chemotherapy have generally been < 20%, with a median overall survival of < 1 year. We report our experience with 6 heavily pretreated patients with advanced PRUC (ClinicalTrials.gov identifier NCT01631552) with the novel antibody-drug conjugate, sacituzumab govitecan (IMMU-132). This antibody-drug conjugate comprises the active metabolite of irinotecan, SN-38, conjugated to an anti-Trop-2 antibody. Trop-2 is widely expressed in ≤ 83% of urothelial carcinomas. Of the 6 patients, 3 had a clinically significant response (progression-free survival, 6.7 to 8.2 months; overall survival, 7.5+ to 11.4+ months). Sacituzumab govitecan was well tolerated. Because of these results, a phase II trial has been initiated. The present report highlights the promise of antibody-drug conjugates, such as sacituzumab govitecan, as a novel therapeutic strategy for the treatment of PRUC.
authors.affiliation: Division of Hematology and Medical Oncology, Weill-Cornell Medical College, New York, NY. Electronic address: bmf9003@nyp.org.
authors.forename: Bishoy
authors.initials: B
authors.lastname: Faltas
authors.affiliation: Immunomedics, Inc., Morris Plains, NJ.
authors.forename: David M
authors.initials: DM
authors.lastname: Goldenberg
authors.affiliation: Division of Hematology and Medical Oncology, Weill-Cornell Medical College, New York, NY.
authors.forename: Allyson J
authors.initials: AJ
authors.lastname: Ocean
authors.affiliation: Immunomedics, Inc., Morris Plains, NJ.
authors.forename: Serengulam V
authors.initials: SV
authors.lastname: Govindan
authors.affiliation: Immunomedics, Inc., Morris Plains, NJ.
authors.forename: Francois
authors.initials: F
authors.lastname: Wilhelm
authors.affiliation: Immunomedics, Inc., Morris Plains, NJ.
authors.forename: Robert M
authors.initials: RM
authors.lastname: Sharkey
authors.affiliation: University of Florida Health Cancer Center at Orlando Health, Orlando, FL.
authors.forename: Julio
authors.initials: J
authors.lastname: Hajdenberg
authors.affiliation: Division of Hematology and Medical Oncology, Weill-Cornell Medical College, New York, NY.
authors.forename: Gillian
authors.initials: G
authors.lastname: Hodes
authors.affiliation: Division of Hematology and Medical Oncology, Weill-Cornell Medical College, New York, NY.
authors.forename: David M
authors.initials: DM
authors.lastname: Nanus
authors.affiliation: Division of Hematology and Medical Oncology, Weill-Cornell Medical College, New York, NY.
authors.forename: Scott T
authors.initials: ST
authors.lastname: Tagawa
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D000972:Antineoplastic Agents, Phytogenic / Q000627:therapeutic use*; D002166:Camptothecin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D018572:Disease-Free Survival; D019008:Drug Resistance, Neoplasm; D006801:Humans; D018796:Immunoconjugates / Q000627:therapeutic use*; D008207:Lymphatic Metastasis; D008297:Male; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000972:Antineoplastic Agents, Phytogenic; D018796:Immunoconjugates; C000608132:sacituzumab govitecan; D002166:Camptothecin
keywords: Antibody–drug conjugates; Clinical trial; IMMU-132; Sacituzumab govitecan; Urothelial carcinoma