TROPiCS-02: A Phase III study investigating sacituzumab govitecan in the treatment of HR+/HER2- metastatic breast cancer

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Authors: Hope S Rugo ; Aditya Bardia ; Sara M Tolaney ; Carlos Arteaga ; Javier Cortes ; Joohyuk Sohn ; Frederik Marmé ; Quan Hong ; Rosemary J Delaney ; Amir Hafeez ; Fabrice André ; Peter Schmid

MeSH: Antibodies, Monoclonal, Humanized / administration & dosage ; Antibodies, Monoclonal, Humanized / adverse effects ; Antibodies, Monoclonal, Humanized / therapeutic use* ; Antigens, Neoplasm ; Antineoplastic Agents, Immunological / administration & dosage ; Antineoplastic Agents, Immunological / adverse effects ; Antineoplastic Agents, Immunological / therapeutic use* ; Biomarkers, Tumor ; Breast Neoplasms / drug therapy* ; Breast Neoplasms / etiology ; Breast Neoplasms / metabolism ; Breast Neoplasms / pathology* ; Camptothecin / administration & dosage ; Camptothecin / adverse effects ; Camptothecin / analogs & derivatives* ; Camptothecin / therapeutic use ; Cell Adhesion Molecules / antagonists & inhibitors ; Drug Resistance, Neoplasm ; Female ; Humans ; Immunoconjugates / administration & dosage ; Immunoconjugates / adverse effects ; Immunoconjugates / therapeutic use* ; Molecular Targeted Therapy ; Neoplasm Metastasis ; Neoplasm Staging ; Receptor, ErbB-2 / antagonists & inhibitors ; Retreatment ; Treatment Outcome

Keywords: HER2-negative ; HR-positive ; MBC ; SN-38 ; Trop-2 ; antibody–drug conjugate ; metastatic breast cancer ; sacituzumab govitecan

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.