A Plain Language Summary of the ASCENT Study: Sacituzumab Govitecan for Metastatic Triple-Negative Breast Cancer

Plain Language Summary

Sacituzumab Govitecan (also known by the brand name TRODELVY^®) is a new and available treatment for metastatic triple-negative breast cancer, or mTNBC for short. Metastatic breast cancer means the breast cancer has spread to other parts of the body. Triple negative means the breast cancer does not have 3 common proteins on the cell surface called receptors. This is a summary of the ASCENT study, published in the New England Journal of Medicine in April 2021. This study compared Sacituzumab Govitecan with standard chemotherapy. Chemotherapy is a treatment that kills cancer cells or stops them from dividing. 529 people with mTNBC took part in the study across 7 countries. All who took part had already received 2 previous chemotherapies, which stopped working for their cancer. The study showed that patients who took Sacituzumab Govitecan lived longer than those who took a different chemotherapy while on the study. Tumors shrank in more patients who took Sacituzumab Govitecan than in patients who took chemotherapy. In general, patients who took Sacituzumab Govitecan experienced more side effects. This included low levels of a type of white blood cell known as neutrophils (neutropenia) and loose or watery stool (diarrhea). Use of supportive care lessened these side effects. This summary also includes insights and perspectives from 2 breast cancer patient advocates.

ClinicalTrials.gov NCT number: NCT02574455.

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Keywords::

• antibody–drug conjugate
• breast cancer
• lay summary
• plain language summary
• Sacituzumab Govitecan
• triple-negative breast cancer
• Trop-2

Financial & competing interests disclosure

A Bardia reports research grants to his institution from Genentech, Novartis, Pfizer, Merck, Sanofi, Radius Health, and Immunomedics, consulting fees from Biothernostics, Inc., Pfizer, Novartis, Genentech, Merck, Radius Health, Immunomedics, Taiho, Sanofi, Diiachi Pharma/AstraZeneca, Puma, Phillips, Eli Lilly, and Foundation Medicine, and travel support from Phillips, Sanofi, Taiho, Immunomedics, Radius Health, Merck, Genentech, Novartis, and Pfizer. S Hurvitz reports contracted research with Ambrx, Amgen, Astra Zeneca, Arvinas, Bayer, Daiichi Sankyo, Genentech/Roche, Gilead, GSK, Immunomedics, Lilly, Macrogenics, Novartis, Pfizer, OBI Pharma, Pieris, PUMA, Radius, Sanofi, SeaFle GeneUcs, Dignitana, Zymeworks, and Phoenix Molecular Designs, Ltd., and stock options with NK Max. H Rugo reports research grants to her institution from Pfizer, Merck, Novartis, Lilly, Genentech, OBI, Odonate, Daiichi, Seattle Genetics, Eisai, Macrogenics, Sermonix, Immunomedics, and AstraZenenca, and travel support from Daiichi, Mylan, Pfizer, Merck, Novartis, AstraZeneca, ad Macrogenics, and honoraria from Mylan, Puma, and Samsung. J Cortes reports research grants to his institution from Roche, Ariad pharmaceuticals, AstraZeneca, Baxalta GMBH/Servier Affaires, Bayer healthcare, Eisai, F. Hoffman-La Roche, Guardanth Health, Merck Sharp & Dohme, Pfizer, Piqur Therapeutics, Puma C, and Queen Mary University of London, consulting fees from Roche, Celgene, Cellestia, AstraZeneca, Biothera Pharmaceutical, Merus, Seattle Genetics, Daiichi Sankyo, Erytech, Athenex, Polyphor, Lilly, Servier, Merck Sharp & Dohme, GSK, Leuko, Bioasis, Clovis Oncology, Boehringer Ingelheim, Kyowa Kirin, Ellipses, Hibercell, BioInvent, and Gemoab, honoraria from Roche, Novartis, Celgene, Eisai, Pfizer, Samsung Bioepis, Lilly, Merck Sharp & Dohme, and Daiichi Sankyo, stock in MedSIR, and travel support from Roche, Novartis, Eisai, Pfizer, and Daiichi Sankyo. S Loibl reports research grants to her institution from Immunomedics, AbbVie, Amgen, AstraZeneca, Celgene, Daiichi Sankyo, Novartis, Pfizer, Roche, BMS, Eirgenix, Lilly, Merck, MSD, SeaGen, Prime/Medscape, Puma, Samsung, Pierre Fabre, Teva, and Vifor, a pending patent on Immunsignature in TNBC (EP14153692.0). M Piccart reports research grants to his institution from AstraZeneca, Immunomedics, Lilly, Menarini, MSD, Novartis, Pfizer, Radius, Roche-Genentech, Servier, and Synthon, consulting fees from Oncolytics, and honoraria from AstraZeneca, Camel-IDS, Debiopharm, Immunomedics, Lilly, Menarini, MSD, Novartis, Odonate, Pfizer, Roche-Genentech, Seattle Genetics, and Immutep. P Spears reports consulting fees for advisory committee from Pfizer, Inc. L Carey reports participation on the advisory board of Sanofi Aventis, Novartis, Genentech/Roche GSK, AstraZeneca/ Daiichi Sanyo, and Aptitude Health. The author has 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.

Acknowledgments

We thank the patients and their caregivers for helping us realize the possibilities of this research; we also thank the dedicated clinical trial investigators and their devoted team members who participated in this trial. We thank Sharon K. Wyhopen, PhD for her critical review and assistance in the development of this article. Medical writing and editorial assistance were provided by Bethsaida Nieves, PhD and Shala Thomas, PhD, CMPP of Team 9 Science, funded by Gilead Sciences, Inc.

Additional information

Funding

We thank the patients and their caregivers for helping us realize the possibilities of this research; we also thank the dedicated clinical trial investigators and their devoted team members who participated in this trial. We thank Sharon K. Wyhopen, PhD for her critical review and assistance in the development of this article. Medical writing and editorial assistance were provided by Bethsaida Nieves, PhD and Shala Thomas, PhD, CMPP of Team 9 Science, funded by Gilead Sciences, Inc.