타깃 · 모달리티 · 임상 근거 · 비임상 맥락으로 최대 5개 프로그램을 나란히 비교합니다. · 자동 수집 갱신 권장 · 9월 2일
현재 선택: 1개 · 임상 갱신 필요 1개
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 |
|---|---|
Overview Program | Padcev (enfortumab vedotin-ejfv) |
Overview Company | Astellas / Pfizer (Seagen) |
Overview Modality | ADC |
Overview Target | Nectin-4 |
Overview Indication | Locally advanced or metastatic urothelial carcinoma |
Overview Phase | APPROVED |
Overview Status | APPROVED |
Overview Content status | Curated Core |
Overview Data Confidence | Editorial scope · Curated Core |
Overview Development Signal | Development Signal · Established |
Overview Approval status | FDA approved |
Positioning Key differentiator | Nectin-4 is near-uniformly expressed in urothelial carcinoma, giving an unusually clean tumor-selective target in that tissue. |
Positioning Known limitation | Nectin-4 loss, MMAE efflux, and tubulin alterations. |
Positioning Development positioning | 1L with pembrolizumab; monotherapy in later lines |
Technology Payload | MMAE (monomethyl auristatin E, tubulin inhibitor) |
Technology Linker | Protease-cleavable mc-vc-PAB, DAR ~3.8 |
Technology DAR | DAR 3.8 |
MoA Mechanism | Binds Nectin-4 on urothelial tumor cells, internalizes, and releases MMAE after cathepsin B cleavage; microtubule disruption arrests mitosis and triggers apoptosis. |
MoA Biomarker | Nectin-4 expression is high in urothelial carcinoma; no companion diagnostic required. |
Toxicology Species | Cynomolgus monkey, Mouse, Rat |
Toxicology Major finding | Boxed warning for serious skin reactions including SJS/TEN. Hyperglycemia, peripheral neuropathy, ocular surface toxicity, and pneumonitis also require monitoring. |
Toxicology CRS | N/A |
Clinical Safety signal | Boxed warning for serious skin reactions including SJS/TEN. Hyperglycemia, peripheral neuropathy, ocular surface toxicity, and pneumonitis also require monitoring. |
Clinical Selected reported efficacy | 95% |
Clinical Reported PFS | 12.5 months vs 6.3 months (platinum chemotherapy) |
Clinical Reported OS | 31.5 months vs 16.1 months (platinum chemotherapy) |
Clinical Result source | FDA approval report 2023-12-15 — EV-302 (NCT04223856) |
Clinical Program phase | APPROVED |
Clinical Trial activity | No active/completed counts |
Clinical Trial ref | NCT04223856 |
타깃 · 모달리티 · 임상 근거 · 비임상 맥락으로 최대 5개 프로그램을 나란히 비교합니다. · 자동 수집 갱신 권장 · 9월 2일
현재 선택: 1개 · 임상 갱신 필요 1개
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 |
|---|---|
Overview Program | Padcev (enfortumab vedotin-ejfv) |
Overview Company | Astellas / Pfizer (Seagen) |
Overview Modality | ADC |
Overview Target | Nectin-4 |
Overview Indication | Locally advanced or metastatic urothelial carcinoma |
Overview Phase | APPROVED |
Overview Status | APPROVED |
Overview Content status | Curated Core |
Overview Data Confidence | Editorial scope · Curated Core |
Overview Development Signal | Development Signal · Established |
Overview Approval status | FDA approved |
Positioning Key differentiator | Nectin-4 is near-uniformly expressed in urothelial carcinoma, giving an unusually clean tumor-selective target in that tissue. |
Positioning Known limitation | Nectin-4 loss, MMAE efflux, and tubulin alterations. |
Positioning Development positioning | 1L with pembrolizumab; monotherapy in later lines |
Technology Payload | MMAE (monomethyl auristatin E, tubulin inhibitor) |
Technology Linker | Protease-cleavable mc-vc-PAB, DAR ~3.8 |
Technology DAR | DAR 3.8 |
MoA Mechanism | Binds Nectin-4 on urothelial tumor cells, internalizes, and releases MMAE after cathepsin B cleavage; microtubule disruption arrests mitosis and triggers apoptosis. |
MoA Biomarker | Nectin-4 expression is high in urothelial carcinoma; no companion diagnostic required. |
Toxicology Species | Cynomolgus monkey, Mouse, Rat |
Toxicology Major finding | Boxed warning for serious skin reactions including SJS/TEN. Hyperglycemia, peripheral neuropathy, ocular surface toxicity, and pneumonitis also require monitoring. |
Toxicology CRS | N/A |
Clinical Safety signal | Boxed warning for serious skin reactions including SJS/TEN. Hyperglycemia, peripheral neuropathy, ocular surface toxicity, and pneumonitis also require monitoring. |
Clinical Selected reported efficacy | 95% |
Clinical Reported PFS | 12.5 months vs 6.3 months (platinum chemotherapy) |
Clinical Reported OS | 31.5 months vs 16.1 months (platinum chemotherapy) |
Clinical Result source | FDA approval report 2023-12-15 — EV-302 (NCT04223856) |
Clinical Program phase | APPROVED |
Clinical Trial activity | No active/completed counts |
Clinical Trial ref | NCT04223856 |
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