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 | |
|---|---|
Overview Program | Enhertu (fam-trastuzumab deruxtecan-nxki) |
Overview Company | Daiichi Sankyo / AstraZeneca |
Overview Modality | ADC |
Overview Target | HER2 |
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 |
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 | High DAR (~8), bystander effect, HER2-low activity |
Positioning Known limitation | HER2 antigen loss/downregulation, payload efflux, and dose-limiting ILD/pneumonitis leading to discontinuation. |
Positioning Development positioning | Indication- and regimen-specific; includes 1L + pertuzumab in HER2-positive metastatic breast cancer |
Technology Payload | DXd (topo-I inhibitor) |
Technology Linker | Cleavable tetrapeptide |
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. |
MoA Biomarker | HER2 expression (IHC/ISH per indication); higher systemic exposure associated with greater ILD incidence (FDA label §12.2). |
Toxicology Species | Cynomolgus monkey, NHP, Rat, Hamster |
Toxicology Animal (cat.) | NHP |
Toxicology Major finding | ILD-like lung findings at high exposure |
Toxicology CRS | Minimal |
Toxicology NOAEL | 10 mg/kg |
Clinical Safety signal | ILD-like lung findings at high exposure |
Clinical Selected reported efficacy | ORR 87% |
Clinical Reported ORR | 87% vs 81% (THP) |
Clinical Reported PFS | 40.7 months vs 26.9 months (THP) |
Clinical Reported OS | Immature at the reported PFS analysis |
Clinical Result source | FDA label 2026, Table 28 — DESTINY-Breast09 (NCT04784715) |
Clinical Program phase | APPROVED |
Clinical Trial activity | No active/completed counts |
Clinical Trial ref | NCT04784715 |
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: 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 | |
|---|---|
Overview Program | Enhertu (fam-trastuzumab deruxtecan-nxki) |
Overview Company | Daiichi Sankyo / AstraZeneca |
Overview Modality | ADC |
Overview Target | HER2 |
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 |
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 | High DAR (~8), bystander effect, HER2-low activity |
Positioning Known limitation | HER2 antigen loss/downregulation, payload efflux, and dose-limiting ILD/pneumonitis leading to discontinuation. |
Positioning Development positioning | Indication- and regimen-specific; includes 1L + pertuzumab in HER2-positive metastatic breast cancer |
Technology Payload | DXd (topo-I inhibitor) |
Technology Linker | Cleavable tetrapeptide |
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. |
MoA Biomarker | HER2 expression (IHC/ISH per indication); higher systemic exposure associated with greater ILD incidence (FDA label §12.2). |
Toxicology Species | Cynomolgus monkey, NHP, Rat, Hamster |
Toxicology Animal (cat.) | NHP |
Toxicology Major finding | ILD-like lung findings at high exposure |
Toxicology CRS | Minimal |
Toxicology NOAEL | 10 mg/kg |
Clinical Safety signal | ILD-like lung findings at high exposure |
Clinical Selected reported efficacy | ORR 87% |
Clinical Reported ORR | 87% vs 81% (THP) |
Clinical Reported PFS | 40.7 months vs 26.9 months (THP) |
Clinical Reported OS | Immature at the reported PFS analysis |
Clinical Result source | FDA label 2026, Table 28 — DESTINY-Breast09 (NCT04784715) |
Clinical Program phase | APPROVED |
Clinical Trial activity | No active/completed counts |
Clinical Trial ref | NCT04784715 |
Preclinical Animal (cat.) | Human, Mouse, In vitro |
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