Expert opinion on biological therapy · 2026
Redefining breast cancer treatment by precision oncology: the clinical impact of sacituzumab govitecan.
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Di Lauro Vincenzo, Sacco Paola Claudia, Palma Valentina, von Arx Claudia, Buono Giuseppe, Caputo Roberta, Piezzo Michela, Cocco Stefania, Vitale Elsa, Santoni Matteo, Gridelli Cesare, De Laurentiis Michelino, Massafra Raffaella, Ciccimarra Francesco, Rizzo Alessandro
Аннотация
INTRODUCTION: Trophoblast cell-surface antigen-2 (Trop-2) is overexpressed in most breast cancers, including about 90% of triple-negative breast cancers (TNBC) and more than half of hormone receptor-positive/HER2-negative (HR+/HER2-) tumors, with limited expression in normal tissues, making it an attractive therapeutic target. Sacituzumab govitecan (SG), the first Trop-2-directed antibody-drug conjugate (ADC) delivers the topoisomerase I inhibitor SN-38 to cancer cells and has changed the treatment of metastatic breast cancer (mBC).
AREAS COVERED: This review synthesizes data from chemical characterization, pharmacokinetic studies, and the clinical evidence from phases I-III in metastatic TNBC and HR+/HER2- mBC (IMMU-132-01, ASCENT, ASCENT-03, ASCENT-04, ASCENT-07, TROPiCS-02) and in early-stage disease. A literature search from PubMed/MEDLINE, Embase, Scopus and ClinicalTrials.gov, complemented by the proceedings of the ASCO, ESMO and SABCS meetings, was performed up to September 2026 using the terms 'sacituzumab govitecan,' 'Trop-2,' 'antibody-drug conjugates' and 'breast cancer'.
EXPERT OPINION: The high drug-to-antibody ratio, membrane-permeable payload and bystander effect of SG explain both its efficacy and its hematological and gastrointestinal toxicity. Its place among the growing family of Trop-2-directed and topoisomerase I payload ADCs will depend on rational sequencing, biomarkers of resistance, and combination with immunotherapy and poly ADP-ribose polymerase inhibitors.
AREAS COVERED: This review synthesizes data from chemical characterization, pharmacokinetic studies, and the clinical evidence from phases I-III in metastatic TNBC and HR+/HER2- mBC (IMMU-132-01, ASCENT, ASCENT-03, ASCENT-04, ASCENT-07, TROPiCS-02) and in early-stage disease. A literature search from PubMed/MEDLINE, Embase, Scopus and ClinicalTrials.gov, complemented by the proceedings of the ASCO, ESMO and SABCS meetings, was performed up to September 2026 using the terms 'sacituzumab govitecan,' 'Trop-2,' 'antibody-drug conjugates' and 'breast cancer'.
EXPERT OPINION: The high drug-to-antibody ratio, membrane-permeable payload and bystander effect of SG explain both its efficacy and its hematological and gastrointestinal toxicity. Its place among the growing family of Trop-2-directed and topoisomerase I payload ADCs will depend on rational sequencing, biomarkers of resistance, and combination with immunotherapy and poly ADP-ribose polymerase inhibitors.