Therapy Detail
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| Therapy Name | Enfortumab vedotin-ejfv + Sacituzumab govitecan-hziy |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Enfortumab vedotin-ejfv | Padcev | AGS-22ME|Enfortumab vedotin|AGS-22M6E|ASG-22CE | Padcev (enfortumab vedotin-ejfv) is an antibody-drug conjugate (ADC) that fuses together a human antibody against NECTIN4 and monomethyl auristatin E, which may result in inhibition of tumor growth and tumor regression (PMID: 27013195). Padcev (enfortumab vedotin-ejfv) is FDA approved for use in patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1 or PD-L1 inhibitor, and a platinum-containing chemotherapy, or who are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy, and in combination with Keytruda (pembrolizumab) for patients with locally advanced or metastatic urothelial carcinoma ineligible for cisplatin-containing chemotherapy (FDA.gov). | |
| Sacituzumab govitecan-hziy | Trodelvy | IMMU-132|Sactizumab|Sacituzumab govitecan | TROP2 Antibody 13 | Trodelvy (sacituzumab govitecan-hziy) is an antibody-drug conjugate (ADC) 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, in patients with hormone receptor-positive, ERBB2 (HER2)-negative breast cancer who have received endocrine-based therapy and at least two additional systemic therapies, and in patients with locally advanced or metastatic urothelial cancer who received a platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT06483334 | Phase Ib/II | Enfortumab vedotin-ejfv + Pembrolizumab + Sacituzumab govitecan-hziy Enfortumab vedotin-ejfv + Sacituzumab govitecan-hziy | A Study of Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Plus Enfortumab Vedotin (EV) With and Without Pembrolizumab in Advanced Urothelial Carcinoma (MK-3475-04C/KEYMAKER-U04) | Recruiting | USA | NLD | ISR | GBR | ESP | CAN | 2 |
| NCT04724018 | Phase I | Enfortumab vedotin-ejfv + Sacituzumab govitecan-hziy | Sacituzumab Govitecan Plus EV in Metastatic UC | Active, not recruiting | USA | 0 |
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