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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