타깃 · 모달리티 · 임상 근거 · 비임상 맥락으로 최대 5개 프로그램을 나란히 비교합니다. · 자동 수집 갱신 권장 · 9월 2일
현재 선택: 4개 · 임상 갱신 필요 4개
프로그램 상세에서 관심 등록 후 2개 이상 모으면 여기서 한 번에 비교할 수 있습니다.
표가 넓으면 좌우로 스크롤하세요. 핵심 비교 모드에서는 중요 항목만 표시됩니다.
| 항목 | enfortumab vedotin-ejfv (Padcev, ASG-22ME, enfortumab-vedotin-ejfv) Astellas / Pfizer (Seagen)·Nectin-4 201 trials | mirvetuximab soravtansine-gynx (Elahere, IMGN853, mirvetuximab-soravtansine-gynx) AbbVie / ImmunoGen·FRα (folate receptor alpha) 32 trials | ||
|---|---|---|---|---|
Overview Program | Padcev (enfortumab vedotin-ejfv) | Imdelltra (tarlatamab) | Elahere (mirvetuximab soravtansine-gynx) | Kymriah (tisagenlecleucel) |
Overview Company | Astellas / Pfizer (Seagen) | Amgen | AbbVie / ImmunoGen | Novartis |
Overview Modality | ADC | ANTIBODY | ADC | CGT |
Overview Target | Nectin-4 | DLL3 × CD3 | FRα (folate receptor alpha) | CD19 |
Overview Indication | Locally advanced or metastatic urothelial carcinoma | Extensive-stage small cell lung cancer after platinum-based chemotherapy | FRα-positive platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer | ALL, DLBCL, FL |
Overview Phase | APPROVED | APPROVED | APPROVED | APPROVED |
Overview Status | APPROVED | APPROVED | APPROVED | APPROVED |
Overview Content status | Curated Core | Curated Core | Curated Core | Curated Core |
Overview Data Confidence | Editorial scope · Curated Core | Editorial scope · Curated Core | Editorial scope · Curated Core | Editorial scope · Curated Core |
Overview Development Signal | Development Signal · Established | Development Signal · Established | Development Signal · Established | Development Signal · Established |
Overview Approval status | FDA approved | FDA approved | FDA approved | FDA approved |
Positioning Key differentiator | Nectin-4 is near-uniformly expressed in urothelial carcinoma, giving an unusually clean tumor-selective target in that tissue. | DLL3 is expressed on ~85–95% of SCLC tumors but almost absent from normal tissue, which is rare for a solid-tumor engager target. | FRα is overexpressed in ovarian cancer but sparse in normal tissue, and the label requires IHC-confirmed expression. | 4-1BB persistence profile |
Positioning Known limitation | Nectin-4 loss, MMAE efflux, and tubulin alterations. | Neuroendocrine-to-non-neuroendocrine plasticity with DLL3 loss; T-cell exhaustion. | FRα downregulation and multidrug-resistance transporter upregulation. | downregulation of naïve T-cell-associated genes (SELL and CD28) |
Positioning Development positioning | 1L with pembrolizumab; monotherapy in later lines | 2L+ | 2L–4L platinum-resistant | — |
Technology Payload | MMAE (monomethyl auristatin E, tubulin inhibitor) | — | DM4 (maytansinoid, tubulin inhibitor) | — |
Technology Linker | Protease-cleavable mc-vc-PAB, DAR ~3.8 | — | Cleavable sulfo-SPDB disulfide, DAR ~3.5 | — |
Technology DAR | DAR 3.8 | — | DAR 3.5 | — |
Technology Vector | — | — | — | Lentivirus |
MoA Mechanism | Binds Nectin-4 on urothelial tumor cells, internalizes, and releases MMAE after cathepsin B cleavage; microtubule disruption arrests mitosis and triggers apoptosis. | Binds DLL3 on SCLC cells and CD3 on T cells, forcing a cytolytic synapse that kills tumor cells regardless of native TCR specificity. | Binds FRα, internalizes via receptor-mediated endocytosis, and releases DM4 after disulfide reduction; tubulin disruption causes mitotic arrest, with lipophilic S-methyl-DM4 giving bystander activity. | Autologous T cells transduced with lentiviral vector encoding CD19-specific CAR with 4-1BB and CD3ζ signaling domains. Engages CD19+ B cells leading to proliferation and cytotoxicity. |
MoA Biomarker | Nectin-4 expression is high in urothelial carcinoma; no companion diagnostic required. | DLL3 expression by IHC is not required in the label but tracks with the biology. | FRα IHC (VENTANA FOLR1 RxDx), PS2+ scoring with ≥75% of tumor cells staining. | CD19; measurable residual disease in ALL. |
Toxicology Species | Cynomolgus monkey, Mouse, Rat | — | Rat | Mouse |
Toxicology Animal (cat.) | — | — | — | Human |
Toxicology Major finding | Boxed warning for serious skin reactions including SJS/TEN. Hyperglycemia, peripheral neuropathy, ocular surface toxicity, and pneumonitis also require monitoring. | Boxed warning for CRS and neurologic toxicity including ICANS. Cytopenia and fatigue are common; step-up dosing with monitoring is mandatory. | Boxed warning for ocular toxicity — keratopathy, blurred vision, and dry eye. Peripheral neuropathy, nausea, and fatigue are also common. | CRS and neurological events; hypogammaglobulinemia from B-cell aplasia. |
Toxicology CRS | N/A | CRS ~51–55%, mostly grade 1–2 | N/A | CRS ~58–79% in ALL; Grade ≥3 CRS managed with tocilizumab per protocol |
Clinical Safety signal | Boxed warning for serious skin reactions including SJS/TEN. Hyperglycemia, peripheral neuropathy, ocular surface toxicity, and pneumonitis also require monitoring. | Boxed warning for CRS and neurologic toxicity including ICANS. Cytopenia and fatigue are common; step-up dosing with monitoring is mandatory. | Boxed warning for ocular toxicity — keratopathy, blurred vision, and dry eye. Peripheral neuropathy, nausea, and fatigue are also common. | CRS and neurological events; hypogammaglobulinemia from B-cell aplasia. |
Clinical Selected reported efficacy | 95% | — | ORR 42% | — |
Clinical Reported ORR | — | — | 42% vs 16% (chemotherapy; rounded in NCI report) | — |
Clinical Reported PFS | 12.5 months vs 6.3 months (platinum chemotherapy) | — | 5.6 months vs 4.0 months (chemotherapy) | — |
Clinical Reported OS | 31.5 months vs 16.1 months (platinum chemotherapy) | — | 16.5 months vs 12.8 months (chemotherapy) | — |
Clinical Result source | FDA approval report 2023-12-15 — EV-302 (NCT04223856) | — | NCI approval analysis 2024 — MIRASOL (NCT04209855) | — |
Clinical Program phase | APPROVED | APPROVED | APPROVED | APPROVED |
Clinical Trial activity | No active/completed counts | No active/completed counts | No active/completed counts | No active/completed counts |
Clinical Trial ref | NCT04223856 | — | NCT04209855 | — |
타깃 · 모달리티 · 임상 근거 · 비임상 맥락으로 최대 5개 프로그램을 나란히 비교합니다. · 자동 수집 갱신 권장 · 9월 2일
현재 선택: 4개 · 임상 갱신 필요 4개
프로그램 상세에서 관심 등록 후 2개 이상 모으면 여기서 한 번에 비교할 수 있습니다.
표가 넓으면 좌우로 스크롤하세요. 핵심 비교 모드에서는 중요 항목만 표시됩니다.
| 항목 | enfortumab vedotin-ejfv (Padcev, ASG-22ME, enfortumab-vedotin-ejfv) Astellas / Pfizer (Seagen)·Nectin-4 201 trials | mirvetuximab soravtansine-gynx (Elahere, IMGN853, mirvetuximab-soravtansine-gynx) AbbVie / ImmunoGen·FRα (folate receptor alpha) 32 trials | ||
|---|---|---|---|---|
Overview Program | Padcev (enfortumab vedotin-ejfv) | Imdelltra (tarlatamab) | Elahere (mirvetuximab soravtansine-gynx) | Kymriah (tisagenlecleucel) |
Overview Company | Astellas / Pfizer (Seagen) | Amgen | AbbVie / ImmunoGen | Novartis |
Overview Modality | ADC | ANTIBODY | ADC | CGT |
Overview Target | Nectin-4 | DLL3 × CD3 | FRα (folate receptor alpha) | CD19 |
Overview Indication | Locally advanced or metastatic urothelial carcinoma | Extensive-stage small cell lung cancer after platinum-based chemotherapy | FRα-positive platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer | ALL, DLBCL, FL |
Overview Phase | APPROVED | APPROVED | APPROVED | APPROVED |
Overview Status | APPROVED | APPROVED | APPROVED | APPROVED |
Overview Content status | Curated Core | Curated Core | Curated Core | Curated Core |
Overview Data Confidence | Editorial scope · Curated Core | Editorial scope · Curated Core | Editorial scope · Curated Core | Editorial scope · Curated Core |
Overview Development Signal | Development Signal · Established | Development Signal · Established | Development Signal · Established | Development Signal · Established |
Overview Approval status | FDA approved | FDA approved | FDA approved | FDA approved |
Positioning Key differentiator | Nectin-4 is near-uniformly expressed in urothelial carcinoma, giving an unusually clean tumor-selective target in that tissue. | DLL3 is expressed on ~85–95% of SCLC tumors but almost absent from normal tissue, which is rare for a solid-tumor engager target. | FRα is overexpressed in ovarian cancer but sparse in normal tissue, and the label requires IHC-confirmed expression. | 4-1BB persistence profile |
Positioning Known limitation | Nectin-4 loss, MMAE efflux, and tubulin alterations. | Neuroendocrine-to-non-neuroendocrine plasticity with DLL3 loss; T-cell exhaustion. | FRα downregulation and multidrug-resistance transporter upregulation. | downregulation of naïve T-cell-associated genes (SELL and CD28) |
Positioning Development positioning | 1L with pembrolizumab; monotherapy in later lines | 2L+ | 2L–4L platinum-resistant | — |
Technology Payload | MMAE (monomethyl auristatin E, tubulin inhibitor) | — | DM4 (maytansinoid, tubulin inhibitor) | — |
Technology Linker | Protease-cleavable mc-vc-PAB, DAR ~3.8 | — | Cleavable sulfo-SPDB disulfide, DAR ~3.5 | — |
Technology DAR | DAR 3.8 | — | DAR 3.5 | — |
Technology Vector | — | — | — | Lentivirus |
MoA Mechanism | Binds Nectin-4 on urothelial tumor cells, internalizes, and releases MMAE after cathepsin B cleavage; microtubule disruption arrests mitosis and triggers apoptosis. | Binds DLL3 on SCLC cells and CD3 on T cells, forcing a cytolytic synapse that kills tumor cells regardless of native TCR specificity. | Binds FRα, internalizes via receptor-mediated endocytosis, and releases DM4 after disulfide reduction; tubulin disruption causes mitotic arrest, with lipophilic S-methyl-DM4 giving bystander activity. | Autologous T cells transduced with lentiviral vector encoding CD19-specific CAR with 4-1BB and CD3ζ signaling domains. Engages CD19+ B cells leading to proliferation and cytotoxicity. |
MoA Biomarker | Nectin-4 expression is high in urothelial carcinoma; no companion diagnostic required. | DLL3 expression by IHC is not required in the label but tracks with the biology. | FRα IHC (VENTANA FOLR1 RxDx), PS2+ scoring with ≥75% of tumor cells staining. | CD19; measurable residual disease in ALL. |
Toxicology Species | Cynomolgus monkey, Mouse, Rat | — | Rat | Mouse |
Toxicology Animal (cat.) | — | — | — | Human |
Toxicology Major finding | Boxed warning for serious skin reactions including SJS/TEN. Hyperglycemia, peripheral neuropathy, ocular surface toxicity, and pneumonitis also require monitoring. | Boxed warning for CRS and neurologic toxicity including ICANS. Cytopenia and fatigue are common; step-up dosing with monitoring is mandatory. | Boxed warning for ocular toxicity — keratopathy, blurred vision, and dry eye. Peripheral neuropathy, nausea, and fatigue are also common. | CRS and neurological events; hypogammaglobulinemia from B-cell aplasia. |
Toxicology CRS | N/A | CRS ~51–55%, mostly grade 1–2 | N/A | CRS ~58–79% in ALL; Grade ≥3 CRS managed with tocilizumab per protocol |
Clinical Safety signal | Boxed warning for serious skin reactions including SJS/TEN. Hyperglycemia, peripheral neuropathy, ocular surface toxicity, and pneumonitis also require monitoring. | Boxed warning for CRS and neurologic toxicity including ICANS. Cytopenia and fatigue are common; step-up dosing with monitoring is mandatory. | Boxed warning for ocular toxicity — keratopathy, blurred vision, and dry eye. Peripheral neuropathy, nausea, and fatigue are also common. | CRS and neurological events; hypogammaglobulinemia from B-cell aplasia. |
Clinical Selected reported efficacy | 95% | — | ORR 42% | — |
Clinical Reported ORR | — | — | 42% vs 16% (chemotherapy; rounded in NCI report) | — |
Clinical Reported PFS | 12.5 months vs 6.3 months (platinum chemotherapy) | — | 5.6 months vs 4.0 months (chemotherapy) | — |
Clinical Reported OS | 31.5 months vs 16.1 months (platinum chemotherapy) | — | 16.5 months vs 12.8 months (chemotherapy) | — |
Clinical Result source | FDA approval report 2023-12-15 — EV-302 (NCT04223856) | — | NCI approval analysis 2024 — MIRASOL (NCT04209855) | — |
Clinical Program phase | APPROVED | APPROVED | APPROVED | APPROVED |
Clinical Trial activity | No active/completed counts | No active/completed counts | No active/completed counts | No active/completed counts |
Clinical Trial ref | NCT04223856 | — | NCT04209855 | — |
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