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Efficacy and Safety of Anti-Trop-2 Antibody Drug Conjugate Sacituzumab Govitecan (IMMU-132) in Heavily Pretreated Patients With Metastatic Triple-Negative Breast Cancer

Journal of clinical oncology, 2017-07, Vol.35 (19), p.2141-2148 [Peer Reviewed Journal]

2017 by American Society of Clinical Oncology 2017 American Society of Clinical Oncology ;ISSN: 0732-183X ;EISSN: 1527-7755 ;DOI: 10.1200/JCO.2016.70.8297 ;PMID: 28291390

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Title:
Efficacy and Safety of Anti-Trop-2 Antibody Drug Conjugate Sacituzumab Govitecan (IMMU-132) in Heavily Pretreated Patients With Metastatic Triple-Negative Breast Cancer
Author: Bardia, Aditya ; Mayer, Ingrid A ; Diamond, Jennifer R ; Moroose, Rebecca L ; Isakoff, Steven J ; Starodub, Alexander N ; Shah, Nikita C ; O'Shaughnessy, Joyce ; Kalinsky, Kevin ; Guarino, Michael ; Abramson, Vandana ; Juric, Dejan ; Tolaney, Sara M ; Berlin, Jordan ; Messersmith, Wells A ; Ocean, Allyson J ; Wegener, William A ; Maliakal, Pius ; Sharkey, Robert M ; Govindan, Serengulam V ; Goldenberg, David M ; Vahdat, Linda T
Subjects: Adult ; Aged ; Aged, 80 and over ; Antibodies, Monoclonal, Humanized - administration & dosage ; Antibodies, Monoclonal, Humanized - adverse effects ; Antigens, Neoplasm - biosynthesis ; Antigens, Neoplasm - immunology ; Antineoplastic Agents - administration & dosage ; Antineoplastic Agents - adverse effects ; Breast Cancer ; Breast Neoplasms, Male - drug therapy ; Breast Neoplasms, Male - immunology ; Breast Neoplasms, Male - metabolism ; Camptothecin - administration & dosage ; Camptothecin - adverse effects ; Camptothecin - analogs & derivatives ; Cell Adhesion Molecules - biosynthesis ; Cell Adhesion Molecules - immunology ; Combined Modality ; Female ; Humans ; Immunoconjugates - administration & dosage ; Immunoconjugates - adverse effects ; Male ; Middle Aged ; Neoplasm Metastasis ; ORIGINAL REPORTS ; Phase I and Clinical Pharmacology ; Triple Negative Breast Neoplasms - drug therapy ; Triple Negative Breast Neoplasms - immunology ; Triple Negative Breast Neoplasms - metabolism
Is Part Of: Journal of clinical oncology, 2017-07, Vol.35 (19), p.2141-2148
Description: Purpose Trop-2, expressed in most triple-negative breast cancers (TNBCs), may be a potential target for antibody-drug conjugates. Sacituzumab govitecan, an antibody-drug conjugate, targets Trop-2 for the selective delivery of SN-38, the active metabolite of irinotecan. Patients and Methods We evaluated sacituzumab govitecan in a single-arm, multicenter trial in patients with relapsed/refractory metastatic TNBC who received a 10 mg/kg starting dose on days 1 and 8 of 21-day repeated cycles. The primary end points were safety and objective response rate; secondary end points were progression-free survival and overall survival. Results In 69 patients who received a median of five prior therapies (range, one to 12) since diagnosis, the confirmed objective response rate was 30% (partial response, n = 19; complete response, n = 2), the median response duration was 8.9 (95% CI, 6.1 to 11.3) months, and the clinical benefit rate (complete response + partial response + stable disease ≥ 6 months) was 46%. These responses occurred early, with a median onset of 1.9 months. Median progression-free survival was 6.0 (95% CI, 5.0 to 7.3) months, and median overall survival was 16.6 (95% CI, 11.1 to 20.6) months. Grade ≥ 3 adverse events included neutropenia (39%), leukopenia (16%), anemia (14%), and diarrhea (13%); the incidence of febrile neutropenia was 7%. The majority of archival tumor specimens (88%) were moderately to strongly positive for Trop-2 by immunohistochemistry. No neutralizing antibodies to the ADC or antibody were detected, despite repeated cycles developed. Conclusion Sacituzumab govitecan was well tolerated and induced early and durable responses in heavily pretreated patients with metastatic TNBC. As a therapeutic target and predictive biomarker, Trop-2 warrants further research.
Publisher: United States: American Society of Clinical Oncology
Language: English
Identifier: ISSN: 0732-183X
EISSN: 1527-7755
DOI: 10.1200/JCO.2016.70.8297
PMID: 28291390
Source: Geneva Foundation Free Medical Journals at publisher websites
MEDLINE
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Efficacy and Safety of Anti-Trop-2 Antibody Drug Conjugate Sacituzumab Govitecan (IMMU-132) in Heavily Pretreated Patients With Metastatic Triple-Negative Breast Cancer

2017 by American Society of Clinical Oncology 2017 American Society of Clinical Oncology ;ISSN: 0732-183X ;EISSN: 1527-7755 ;DOI: 10.1200/JCO.2016.70.8297 ;PMID: 28291390

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