sacituzumab govitecan

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Ligands
sacituzumab govitecan

GtoPdb Ligand ID: 8253

Synonyms: hRS7-SN-38-ADC | IMMU-132 | sacituzumab govitecan-hziy | Trodelvy®

sacituzumab govitecan is an approved drug (FDA (2020), EMA (2021))

Comment: IMMU-132 is an antibody-drug conjugate (ADC) with SN-38 (the active metabolite of the topoisomerase inhibitor irinotecan) covalently linked to an anti-TROP-2 monoclonal antibody (see patent US8574575 [1]) [2-3,5]. TROP-2 is a transmembrane glycoprotein, cell surface antigen which has oncogenic activity in cancers of epithelial origin [6], but expression is restricted in normal tissue. Directing SN-38 to cancer cells via TROP-2 binding is predicted to limit toxicity towards healthy tissue/cells.

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Summary of Clinical Use
Sacituzumab govitecan (IMMU-132) was progressed to clinical evaluation as a therapy for epithelial-derived cancers. The US FDA granted fast track status for IMMU-132 as a therapy for triple negative breast cancer (TNBC) and small-cell lung cancer (SCLC) and orphan designation for SCLC and pancreatic cancer. In April 2020, the FDA approved sacituzumab govitecan as a therapy for heavily pretreated metastatic TNBC (at least two prior therapies in the metastatic setting). In April 2021, the FDA granted accelerated approval as a therapy for advanced or metastatic urothelial cancer, in patients who have already been treated with a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor. January 2023 saw expansion of FDA approval to include treament of unresectable locally advanced or metastatic hormone receptor positive, HER2-negative breast cancer (in patients who have already been treated with endocrine-based therapy and at ≥2 additional systemic therapies in the metastatic setting)

Summary of Clinical Use

Sacituzumab govitecan (IMMU-132) was progressed to clinical evaluation as a therapy for epithelial-derived cancers. The US FDA granted fast track status for IMMU-132 as a therapy for triple negative breast cancer (TNBC) and small-cell lung cancer (SCLC) and orphan designation for SCLC and pancreatic cancer. In April 2020, the FDA approved sacituzumab govitecan as a therapy for heavily pretreated metastatic TNBC (at least two prior therapies in the metastatic setting). In April 2021, the FDA granted accelerated approval as a therapy for advanced or metastatic urothelial cancer, in patients who have already been treated with a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor. January 2023 saw expansion of FDA approval to include treament of unresectable locally advanced or metastatic hormone receptor positive, HER2-negative breast cancer (in patients who have already been treated with endocrine-based therapy and at ≥2 additional systemic therapies in the metastatic setting)

Clinical Trials
Clinical Trial ID	Title	Type	Source	Comment	References
NCT02161679	Phase II Study of IMMU-132 Alone or in Combination With Carboplatin in Patients With Triple-Negative Breast Cancer	Phase 2 Interventional	Immunomedics, Inc.
NCT02574455	ASCENT-Study of Sacituzumab Govitecan in Refractory/Relapsed Triple-Negative Breast Cancer	Phase 3 Interventional	Immunomedics, Inc.	Approval for TNBC was based on evidence of efficacy from this trial.
NCT01631552	Phase I/II Study of IMMU-132 in Patients With Epithelial Cancers	Phase 1/Phase 2 Interventional	Immunomedics, Inc.