Therapy Detail

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Therapy Name Sacituzumab govitecan-hziy
Synonyms
Therapy Description

Sacituzumab govitecan is an antibody-drug conjugate composed of a monoclonal anti-TROP2 antibody linked to the active metabolite of irinotecan (SN-38), which binds to TROP2 positive cancer cells and induces DNA breakage and apoptosis (PMID: 26541586).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Sacituzumab govitecan-hziy Trodelvy IMMU-132|Sactizumab Trodelvy (sacituzumab govitecan-hziy) is an antibody-drug conjugate composed of a monoclonal anti-TROP2 antibody linked to the active metabolite of irinotecan (SN-38), which binds to TROP2 positive cancer cells and induces DNA breakage and apoptosis (PMID: 26541586). Trodelvy (sacituzumab govitecan-hziy) is FDA approved for use in patients with metastatic triple-negative breast cancer who received two or more prior therapies, and in patients with locally advanced or metastatic urothelial cancer who received a platinum-containing chemotherapy and a PD-1 orPD-L1 inhibitor (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown lung small cell carcinoma not applicable Sacituzumab govitecan-hziy Phase Ib/II Actionable In a Phase I/II trial (IMMU-132-01), Trodelvy (sacituzumab govitecan-hziy) treatment demonstrated safety, resulted in an objective response rate of 14% (7/50, 7 partial response) in patients with metastatic small cell lung cancer, Tacstd2 (Trop-2) expression was detected in 92% (23/25) of assessable tumor tissues, although expression level did not correlate with progression-free survival or overall survival (PMID: 28679770; NCT01631552). 28679770
Unknown unknown transitional cell carcinoma not applicable Sacituzumab govitecan-hziy FDA approved Actionable In a Phase II trial (TROPHY-U-01) that supported FDA approval, Trodelvy (sacituzumab govitecan-hziy) treatment resulted in an objective response rate of 27% (31/113) in patients with metastatic urothelial carcinoma whose disease progressed on platinum-based regimens or immunotherapy, with a clinical benefit rate of 37%, a median duration of response, progression-free survival, and overall survival of 5.9, 5.4, 10.5 months, respectively (Ann Oncol. 2020, 31 (Suppl_4): S1142-S1215; NCT03547973). detail... detail...
Unknown unknown Advanced Solid Tumor not applicable Sacituzumab govitecan-hziy Phase Ib/II Actionable In a Phase I/II trial (IMMU-132-01), Trodelvy (sacituzumab govitecan-hziy) demonstrated safety and preliminary efficacy, resulted in a partial response in 8% (2/25) and stable disease in 64% (16/25) of patients with advanced solid tumors, with a time-to-progression of 3.6 months (PMID: 25944802; NCT01631552). 25944802
Unknown unknown triple-receptor negative breast cancer not applicable Sacituzumab govitecan-hziy FDA approved Actionable In a Phase I/II trial (IMMU-132-01) that supported FDA approval, Trodelvy (sacituzumab govitecan-hziy) treatment resulted in an objective response rate of 33.3% (36/108, 3 complete response, 33 partial response) and a clinical benefit rate of 45.4% in patients with metastatic triple-negative breast cancer who received two or more prior therapies, with a median duration of response, progression-free survival, and overall survival of 7.7, 5.5, and 13.0 months respectively (PMID: 30786188; NCT01631552). 30786188 detail...
Unknown unknown triple-receptor negative breast cancer not applicable Sacituzumab govitecan-hziy Case Reports/Case Series Actionable In a Phase I/II trial (IMMU-132-01), Trodelvy (sacituzumab govitecan-hziy) treatment resulted in a partial response in a patient with triple-negative breast cancer (PMID: 25944802; NCT01631552). 25944802

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT04468061 Phase II Sacituzumab govitecan-hziy Pembrolizumab + Sacituzumab govitecan-hziy Sacituzumab Govitecan +/- Pembrolizumab in Metastatic TNBC Recruiting USA 0
NCT04251416 Phase II Sacituzumab govitecan-hziy A Study of Sacituzumab Govitecan (IMMU-132) in Endometrial Carcinoma Recruiting USA 0
NCT04448886 Phase II Sacituzumab govitecan-hziy Pembrolizumab + Sacituzumab govitecan-hziy Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC Recruiting USA 0
NCT03901339 Phase III Eribulin Gemcitabine Vinorelbine Capecitabine Sacituzumab govitecan-hziy Study of IMMU-132 in HR+/HER2- MBC (TROPICS-02) Active, not recruiting USA | CAN 7
NCT03964727 Phase II Sacituzumab govitecan-hziy A Study of Sacituzumab Govitecan in Metastatic Solid Tumors (Tropics-03) Recruiting USA 0
NCT02574455 Phase III Sacituzumab govitecan-hziy Capecitabine + Eribulin + Gemcitabine + Vinorelbine ASCENT-Study of Sacituzumab Govitecan in Refractory/Relapsed Triple-Negative Breast Cancer (ASCENT) Completed USA | CAN 5
NCT03547973 Phase II Sacituzumab govitecan-hziy Phase II Open Label, Study of IMMU-132 in Metastatic Urothelial Cancer Recruiting USA 1
NCT04230109 Phase II Sacituzumab govitecan-hziy Sacituzumab Govitecan In TNBC (NeoSTAR) Recruiting USA 0
NCT04527991 Phase III Paclitaxel Docetaxel Vinflunine Sacituzumab govitecan-hziy Study of Sacituzumab Govitecan (IMMU-132) in Metastatic or Locally Advanced Unresectable Urothelial Cancer (TROPiCS-04) Recruiting USA 1
NCT03995706 Phase I Sacituzumab govitecan-hziy Neuro/Sacituzumab Govitecan/Breast Brain Metastasis/Glioblastoma/Ph 0 Recruiting USA 0
NCT03725761 Phase II Sacituzumab govitecan-hziy IMMU-132 in Patients With Metastatic Castration-Resistant Prostate Cancer Progressing on Second Generation AR-Directed Therapy Suspended USA 0
NCT04647916 Phase II Sacituzumab govitecan-hziy Testing Sacituzumab Govitecan Therapy in Patients With HER2-Negative Breast Cancer and Brain Metastases Recruiting USA 0


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