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 | disitamab vedotin (Disitamab Vedotin, RC48, Disitamab Vedotin(RC48) Plus Tratuzumab) RemeGen·HER2 91 trials | |
|---|---|---|
Overview Program | Enhertu (fam-trastuzumab deruxtecan-nxki) | Disitamab Vedotin(RC48) Plus Tratuzumab |
Overview Company | Daiichi Sankyo / AstraZeneca | RemeGen |
Overview Modality | ADC | ADC |
Overview Target | HER2 | 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 | HER2-positive Gastric Cancer; HER2-positive Gastroesophageal Junction Adenocarcinoma |
Overview Phase | APPROVED | PHASE_2 |
Overview Status | APPROVED | RECRUITING |
Overview Content status | Curated Core | Standard Database |
Overview Data Confidence | Editorial scope · Curated Core | Editorial scope · structured catalog |
Overview Development Signal | Development Signal · Established | Development Signal · Emerging |
Overview Approval status | FDA approved | Investigational |
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 | linker |
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. | ADC is revealed to exert its antitumor effect by inducing G2/M arrest and caspase-dependent apoptosis |
MoA Biomarker | HER2 expression (IHC/ISH per indication); higher systemic exposure associated with greater ILD incidence (FDA label §12.2). | PD-1 blockade and gemcitabine/cisplatin in high |
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 | PHASE_2 |
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: 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 | disitamab vedotin (Disitamab Vedotin, RC48, Disitamab Vedotin(RC48) Plus Tratuzumab) RemeGen·HER2 91 trials | |
|---|---|---|
Overview Program | Enhertu (fam-trastuzumab deruxtecan-nxki) | Disitamab Vedotin(RC48) Plus Tratuzumab |
Overview Company | Daiichi Sankyo / AstraZeneca | RemeGen |
Overview Modality | ADC | ADC |
Overview Target | HER2 | 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 | HER2-positive Gastric Cancer; HER2-positive Gastroesophageal Junction Adenocarcinoma |
Overview Phase | APPROVED | PHASE_2 |
Overview Status | APPROVED | RECRUITING |
Overview Content status | Curated Core | Standard Database |
Overview Data Confidence | Editorial scope · Curated Core | Editorial scope · structured catalog |
Overview Development Signal | Development Signal · Established | Development Signal · Emerging |
Overview Approval status | FDA approved | Investigational |
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 | linker |
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. | ADC is revealed to exert its antitumor effect by inducing G2/M arrest and caspase-dependent apoptosis |
MoA Biomarker | HER2 expression (IHC/ISH per indication); higher systemic exposure associated with greater ILD incidence (FDA label §12.2). | PD-1 blockade and gemcitabine/cisplatin in high |
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 | PHASE_2 |
Clinical Trial activity | No active/completed counts | — |
Clinical Trial ref | NCT04784715 | — |
Preclinical Animal (cat.) | Human, Mouse, In vitro | — |
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