타깃 · 모달리티 · 임상 근거 · 비임상 맥락으로 최대 5개 프로그램을 나란히 비교합니다. · 자동 수집 갱신 권장 · 9월 2일
현재 선택: 2개 · 임상 갱신 필요 2개 · Data Tier에서 열림
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) | Disitamab Vedotin (RC48) |
Overview Company | Astellas / Pfizer (Seagen) | RemeGen |
Overview Modality | ADC | ADC |
Overview Target | Nectin-4 | HER2 |
Overview Indication | Locally advanced or metastatic urothelial carcinoma | HER2+ urothelial, gastric, breast |
Overview Phase | APPROVED | APPROVED |
Overview Status | APPROVED | ACTIVE |
Overview Content status | Curated Core | Curated Core |
Overview Data Confidence | Editorial scope · Curated Core | Editorial scope · Curated Core |
Overview Development Signal | Development Signal · Established | Development Signal · Established |
Overview Approval status | FDA approved | Approved (flag incomplete) |
Positioning Key differentiator | Nectin-4 is near-uniformly expressed in urothelial carcinoma, giving an unusually clean tumor-selective target in that tissue. | Novel anti-HER2 mAb with distinct epitope |
Positioning Known limitation | Nectin-4 loss, MMAE efflux, and tubulin alterations. | resistance mechanisms, optimize payload delivery, and minimize off-target toxicity |
Positioning Development positioning | 1L with pembrolizumab; monotherapy in later lines | 2L+ |
Technology Payload | MMAE (monomethyl auristatin E, tubulin inhibitor) | MMAE |
Technology Linker | Protease-cleavable mc-vc-PAB, DAR ~3.8 | Cleavable |
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. | Disitamab vedotin binds a distinct HER2 epitope (different from trastuzumab), internalizes, and releases MMAE via cleavable linker, causing microtubule disruption and apoptosis. |
MoA Biomarker | Nectin-4 expression is high in urothelial carcinoma; no companion diagnostic required. | HER2 expression (IHC); activity in HER2+ urothelial and gastric cancers. |
Toxicology Species | Cynomolgus monkey, Mouse, Rat | Cynomolgus monkey |
Toxicology Animal (cat.) | — | NHP |
Toxicology Major finding | Boxed warning for serious skin reactions including SJS/TEN. Hyperglycemia, peripheral neuropathy, ocular surface toxicity, and pneumonitis also require monitoring. | Hematologic toxicity and peripheral neuropathy class effects of MMAE; ILD reported at lower frequency than DXd ADCs in published datasets. |
Toxicology CRS | N/A | 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. | Hematologic toxicity and peripheral neuropathy class effects of MMAE; ILD reported at lower frequency than DXd ADCs in published datasets. |
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 | APPROVED |
Clinical Trial activity | No active/completed counts | 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: 2개 · 임상 갱신 필요 2개 · Data Tier에서 열림
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) | Disitamab Vedotin (RC48) |
Overview Company | Astellas / Pfizer (Seagen) | RemeGen |
Overview Modality | ADC | ADC |
Overview Target | Nectin-4 | HER2 |
Overview Indication | Locally advanced or metastatic urothelial carcinoma | HER2+ urothelial, gastric, breast |
Overview Phase | APPROVED | APPROVED |
Overview Status | APPROVED | ACTIVE |
Overview Content status | Curated Core | Curated Core |
Overview Data Confidence | Editorial scope · Curated Core | Editorial scope · Curated Core |
Overview Development Signal | Development Signal · Established | Development Signal · Established |
Overview Approval status | FDA approved | Approved (flag incomplete) |
Positioning Key differentiator | Nectin-4 is near-uniformly expressed in urothelial carcinoma, giving an unusually clean tumor-selective target in that tissue. | Novel anti-HER2 mAb with distinct epitope |
Positioning Known limitation | Nectin-4 loss, MMAE efflux, and tubulin alterations. | resistance mechanisms, optimize payload delivery, and minimize off-target toxicity |
Positioning Development positioning | 1L with pembrolizumab; monotherapy in later lines | 2L+ |
Technology Payload | MMAE (monomethyl auristatin E, tubulin inhibitor) | MMAE |
Technology Linker | Protease-cleavable mc-vc-PAB, DAR ~3.8 | Cleavable |
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. | Disitamab vedotin binds a distinct HER2 epitope (different from trastuzumab), internalizes, and releases MMAE via cleavable linker, causing microtubule disruption and apoptosis. |
MoA Biomarker | Nectin-4 expression is high in urothelial carcinoma; no companion diagnostic required. | HER2 expression (IHC); activity in HER2+ urothelial and gastric cancers. |
Toxicology Species | Cynomolgus monkey, Mouse, Rat | Cynomolgus monkey |
Toxicology Animal (cat.) | — | NHP |
Toxicology Major finding | Boxed warning for serious skin reactions including SJS/TEN. Hyperglycemia, peripheral neuropathy, ocular surface toxicity, and pneumonitis also require monitoring. | Hematologic toxicity and peripheral neuropathy class effects of MMAE; ILD reported at lower frequency than DXd ADCs in published datasets. |
Toxicology CRS | N/A | 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. | Hematologic toxicity and peripheral neuropathy class effects of MMAE; ILD reported at lower frequency than DXd ADCs in published datasets. |
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 | APPROVED |
Clinical Trial activity | No active/completed counts | No active/completed counts |
Clinical Trial ref | NCT04223856 | — |
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