@article{f4a5782687614d119d3a2ecfd6a0379f,
title = "TROPiCS-02: A Phase III study investigating sacituzumab govitecan in the treatment of HR+/HER2-metastatic breast cancer",
abstract = "Patients with HR+/HER2-metastatic breast cancer (MBC) whose cancers have progressed despite conventional therapies represent an unmet clinical need. Trop-2, a transmembrane calcium signal transducer, is highly expressed in MBC and plays a role in tumor growth and progression. Sacituzumab govitecan (SG) is a novel antibody-drug conjugate comprising an Trop-2 antibody coupled to SN-38, the active metabolite of irinotecan, via a unique hydrolyzable linker. SG has demonstrated promising activity in a Phase I/II IMMU-132-01 basket study in heavily pretreated solid tumors, including HR+/HER2-MBC. We describe the registrational Phase III TROPiCS-02 study (NCT03901339), evaluating SG versus treatment of physician's choice in HR+/HER2-MBC. Trial registration number: NCT03901339.",
keywords = "HER2-negative, HR-positive, MBC, SN-38, Trop-2, antibody-drug conjugate, metastatic breast cancer, sacituzumab govitecan",
author = "Rugo, {Hope S.} and Aditya Bardia and Tolaney, {Sara M.} and Carlos Arteaga and Javier Cortes and Joohyuk Sohn and Frederik Marm{\'e} and Quan Hong and Delaney, {Rosemary J.} and Amir Hafeez and Fabrice Andr{\'e} and Peter Schmid",
note = "Funding Information: The study was sponsored by Immunomedics, Inc. and was designed through a collaboration between the sponsor and the lead investigators. HS Rugo has received research grants to the UC Regents from Pfizer, Novartis, Eli Lilly, F. Hoffmann-La Roche, Macro-genics, Merck, OBI Pharma, Eisai, Daiichi Sankyo, Odonate, Seattle Genetics and Immunomedics, Inc.; and has received travel, accommodations or expenses from Puma Biotechnology, Mylan Pharmaceutics, Lilly, Pfizer, Amgen, F. Hoffmann-La Roche and AstraZeneca. A Bardia has served as a consultant/advisor for Biotheranostics, Pfizer, Novartis, Genentech, Merck, Radius Health, Immunomedics, Spectrum Pharmaceuticals, Taiho Pharmaceutical, Sanofi, Daiichi Pharma/Astra Zeneca, Puma Biotechnology, Lilly and Philipps; has received research funding from Genentech/F Hoffman-La Roche, Novartis, Pfizer, Merck, Sanofi, Radius Health, Immunomedics, Mersana Therapeutics, Innocrin Pharmaceuticals and Biothernostics. SM Tolaney has served as a consultant/advisor for Novartis, Eli Lilly, Pfizer, Immunomedics, Merck, NanoString Technologies, Nektar Therapeutics, Eisai, AstraZeneca, Genentech/F. Hoffmann-La Roche, Puma Biotechnology, Sanofi, Athenex, Seattle Genetics, Silverback Therapeutics, G1 Therapeutics, Paxman, Odonate, AbbVie, Bristol-Myers Squibb and Celldex Therapeutics; and has institutional research funding from AstraZeneca, Eli Lilly, Merck, Nektar Therapeutics, Novartis, Pfizer, Genentech/F. Hoffmann-La Roche, Eisai, NanoString Technologies, Immunomedics, AstraZeneca, Eli Lilly, Merck, Nektar Therapeutics, Novartis, Pfizer, Eisai, NanoString Technologies, Exelixis, Cyclacel, Odonate and Bristol-Myers Squibb. C Arteaga has served as a consultant/advisor for AbbVie, Novartis, Eli Lilly, Sanofi, Radius Health, Taiho Pharmaceutical, Puma Biotechnology, Merck, H3 Biomedicine OrigiMed, Immunomedics, Petra Pharma, G1 Therapeutics, Athenex, Daiichi Sankyo and Clovis; has ownership interest (stock, stock options or other ownership interest excluding diversified mutual funds) in Provista and Y-TRAP; and has received research funding from Pfizer, Eli Lilly, Bayer HealthCare Pharmaceuticals and Takeda; is on the Scientific Advisory Board for Susan G Komen for the Cure Breast Cancer Foundation and is a Scientific Steering Committee member for TROPiCS-02, the subject of the manuscript. J Cortes has a patent with MedSIR; has served as a consultant/advisor for Genentech/F Hoffmann-La Roche, Celgene, Cellestia, AstraZeneca, Biothera Pharmaceutical, Merus, Seattle Genetics, Daiichi Sankyo, Erytech, Athenex, Polyphor, Lilly, Servier, Merck Sharp & Dohme, GSK, Leuko, Bioasis, Clovis Oncology; has received honoraria from Genentech/F Hoffmann-La Roche, Novartis, Celgene, Eisai, Pfizer, Samsung Bioepis, Lilly, Merck Sharp & Dohme and Daiichi Sankyo; has research funding from F Hoffmann-La Roche, ARIAD Pharmaceuticals, AstraZeneca, Baxalta GMBH/Servier Affaires, Bayer HealthCare Pharmaceuticals, Eisai, Guardant Health, Merck Sharp & Dohme, Pfizer, PIQUR Therapeutics, Puma Biotechnology and Queen Mary University of London; and has received travel, accommodations or expenses from Genentech/F Hoffmann-La Roche, Novartis, Eisai, Pfizer and Daiichi Sankyo. J Sohn has received research funding from Bayer HealthCare Pharmaceuticals, GlaxoSmithKline, Contessa, Daiichi Sankyo, F Hoffmann-La Roche, Novartis, AstraZeneca, Eli Lilly, Merck, Sharp & Dohme and Pfizer. F Marm{\'e} has served as a consultant/advisor for AstraZeneca, Tesaro, F Hoffmann-La Roche, Novartis, Amgen, Pfizer, CureVac, PharmaMar, Eisai, Bristol-Myers Squibb, Genomic Health; and has provided contracted research for and received honoraria from Immunomedics. Q Hong is an employee of and holds ownership interest in Immunomedics; has a spouse/partner who is an employee of and holds ownership interest in Merck; and has received travel, accommodations or expenses from Advaxis. RJ Delaney and A Hafeez are employees of and hold ownership interest in Immunomedics. F Andr{\'e} has received research funding from AstraZeneca, Pfizer, Eli Lilly, F Hoffmann-La Roche, Novartis and Daiichi Sankyo. P Schmid has a spouse/partner who is a consultant of Genentech/F Hoffmann-La Roche; has received research funding from Genentech/F Hoffmann-La Roche, OncoGenex Pharmaceuticals and Novartis; has received honoraria from Bayer HealthCare Pharmaceuticals, Eisai, Bristol-Myers Squibb, Puma Biotechnology, Pfizer, AstraZeneca, Novartis, F Hoffmann-La Roche, Merck, Boehringer Ingelheim; and was an uncompensated steering committee member for the IMpassion130 trial. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Medical writing assistance was provided by Shala Thomas, PhD of Team 9 Science and was funded by Immunomedics, Inc. Publisher Copyright: {\textcopyright} 2020 Hope S. Rugo, MD.",
year = "2020",
month = apr,
doi = "10.2217/fon-2020-0163",
language = "English (US)",
volume = "16",
pages = "705--712",
journal = "Future Oncology",
issn = "1479-6694",
publisher = "Future Medicine Ltd.",
number = "12",
}