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 | Enhertu (fam-trastuzumab deruxtecan-nxki) | Padcev (enfortumab vedotin-ejfv) |
Overview Company | Daiichi Sankyo / AstraZeneca | Astellas / Pfizer (Seagen) |
Overview Modality | ADC | ADC |
Overview Target | HER2 | Nectin-4 |
Overview Indication | HER2-positive breast cancer (including regimen-specific first-line and early-stage indications); HER2-low/ultralow breast cancer, HER2-positive gastric cancer, HER2-mutant NSCLC and HER2-positive solid tumors: consult the current US label | Locally advanced or metastatic urothelial carcinoma |
Overview Phase | APPROVED | APPROVED |
Overview Status | APPROVED | APPROVED |
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 | FDA approved |
Positioning Key differentiator | High DAR (~8), bystander effect, HER2-low activity | Nectin-4 is near-uniformly expressed in urothelial carcinoma, giving an unusually clean tumor-selective target in that tissue. |
Positioning Known limitation | HER2 antigen loss/downregulation, payload efflux, and dose-limiting ILD/pneumonitis leading to discontinuation. | Nectin-4 loss, MMAE efflux, and tubulin alterations. |
Positioning Development positioning | Indication- and regimen-specific; includes 1L + pertuzumab in HER2-positive metastatic breast cancer | 1L with pembrolizumab; monotherapy in later lines |
Technology Payload | DXd (topo-I inhibitor) | MMAE (monomethyl auristatin E, tubulin inhibitor) |
Technology Linker | Cleavable tetrapeptide | Protease-cleavable mc-vc-PAB, DAR ~3.8 |
Technology DAR | — | DAR 3.8 |
MoA Mechanism | Fam-trastuzumab deruxtecan is a HER2-directed antibody-drug conjugate: humanized anti-HER2 IgG1 linked via a cleavable tetrapeptide linker to DXd, a membrane-permeable topoisomerase I inhibitor. After binding HER2 on tumor cells, the conjugate is internalized; lysosomal proteases cleave the linker and release DXd, causing DNA damage and apoptosis. Released DXd can exert a bystander effect in neighboring cells. | Binds Nectin-4 on urothelial tumor cells, internalizes, and releases MMAE after cathepsin B cleavage; microtubule disruption arrests mitosis and triggers apoptosis. |
MoA Biomarker | HER2 expression (IHC/ISH per indication); higher systemic exposure associated with greater ILD incidence (FDA label §12.2). | Nectin-4 expression is high in urothelial carcinoma; no companion diagnostic required. |
Toxicology Species | Cynomolgus monkey, NHP, Rat, Hamster | Cynomolgus monkey, Mouse, Rat |
Toxicology Animal (cat.) | NHP | — |
Toxicology Major finding | ILD-like lung findings at high exposure | Boxed warning for serious skin reactions including SJS/TEN. Hyperglycemia, peripheral neuropathy, ocular surface toxicity, and pneumonitis also require monitoring. |
Toxicology CRS | Minimal | N/A |
Toxicology NOAEL | 10 mg/kg | — |
Clinical Safety signal | ILD-like lung findings at high exposure | Boxed warning for serious skin reactions including SJS/TEN. Hyperglycemia, peripheral neuropathy, ocular surface toxicity, and pneumonitis also require monitoring. |
Clinical Selected reported efficacy | ORR 87% | 95% |
Clinical Reported ORR | 87% vs 81% (THP) | — |
Clinical Reported PFS | 40.7 months vs 26.9 months (THP) | 12.5 months vs 6.3 months (platinum chemotherapy) |
Clinical Reported OS | Immature at the reported PFS analysis | 31.5 months vs 16.1 months (platinum chemotherapy) |
Clinical Result source | FDA label 2026, Table 28 — DESTINY-Breast09 (NCT04784715) | 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 | NCT04784715 | NCT04223856 |
Preclinical Animal (cat.) | Human, Mouse, In vitro | — |
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 | Enhertu (fam-trastuzumab deruxtecan-nxki) | Padcev (enfortumab vedotin-ejfv) |
Overview Company | Daiichi Sankyo / AstraZeneca | Astellas / Pfizer (Seagen) |
Overview Modality | ADC | ADC |
Overview Target | HER2 | Nectin-4 |
Overview Indication | HER2-positive breast cancer (including regimen-specific first-line and early-stage indications); HER2-low/ultralow breast cancer, HER2-positive gastric cancer, HER2-mutant NSCLC and HER2-positive solid tumors: consult the current US label | Locally advanced or metastatic urothelial carcinoma |
Overview Phase | APPROVED | APPROVED |
Overview Status | APPROVED | APPROVED |
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 | FDA approved |
Positioning Key differentiator | High DAR (~8), bystander effect, HER2-low activity | Nectin-4 is near-uniformly expressed in urothelial carcinoma, giving an unusually clean tumor-selective target in that tissue. |
Positioning Known limitation | HER2 antigen loss/downregulation, payload efflux, and dose-limiting ILD/pneumonitis leading to discontinuation. | Nectin-4 loss, MMAE efflux, and tubulin alterations. |
Positioning Development positioning | Indication- and regimen-specific; includes 1L + pertuzumab in HER2-positive metastatic breast cancer | 1L with pembrolizumab; monotherapy in later lines |
Technology Payload | DXd (topo-I inhibitor) | MMAE (monomethyl auristatin E, tubulin inhibitor) |
Technology Linker | Cleavable tetrapeptide | Protease-cleavable mc-vc-PAB, DAR ~3.8 |
Technology DAR | — | DAR 3.8 |
MoA Mechanism | Fam-trastuzumab deruxtecan is a HER2-directed antibody-drug conjugate: humanized anti-HER2 IgG1 linked via a cleavable tetrapeptide linker to DXd, a membrane-permeable topoisomerase I inhibitor. After binding HER2 on tumor cells, the conjugate is internalized; lysosomal proteases cleave the linker and release DXd, causing DNA damage and apoptosis. Released DXd can exert a bystander effect in neighboring cells. | Binds Nectin-4 on urothelial tumor cells, internalizes, and releases MMAE after cathepsin B cleavage; microtubule disruption arrests mitosis and triggers apoptosis. |
MoA Biomarker | HER2 expression (IHC/ISH per indication); higher systemic exposure associated with greater ILD incidence (FDA label §12.2). | Nectin-4 expression is high in urothelial carcinoma; no companion diagnostic required. |
Toxicology Species | Cynomolgus monkey, NHP, Rat, Hamster | Cynomolgus monkey, Mouse, Rat |
Toxicology Animal (cat.) | NHP | — |
Toxicology Major finding | ILD-like lung findings at high exposure | Boxed warning for serious skin reactions including SJS/TEN. Hyperglycemia, peripheral neuropathy, ocular surface toxicity, and pneumonitis also require monitoring. |
Toxicology CRS | Minimal | N/A |
Toxicology NOAEL | 10 mg/kg | — |
Clinical Safety signal | ILD-like lung findings at high exposure | Boxed warning for serious skin reactions including SJS/TEN. Hyperglycemia, peripheral neuropathy, ocular surface toxicity, and pneumonitis also require monitoring. |
Clinical Selected reported efficacy | ORR 87% | 95% |
Clinical Reported ORR | 87% vs 81% (THP) | — |
Clinical Reported PFS | 40.7 months vs 26.9 months (THP) | 12.5 months vs 6.3 months (platinum chemotherapy) |
Clinical Reported OS | Immature at the reported PFS analysis | 31.5 months vs 16.1 months (platinum chemotherapy) |
Clinical Result source | FDA label 2026, Table 28 — DESTINY-Breast09 (NCT04784715) | 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 | NCT04784715 | NCT04223856 |
Preclinical Animal (cat.) | Human, Mouse, In vitro | — |
추천 비교
추천 비교