구조모아 (StructureMoa)항암 chemical structure spider web
방문프로그램 상세에서 관심 등록 후 2개 이상 모으면 여기서 한 번에 비교할 수 있습니다.
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| 항목 | enfortumab vedotin (Padcev, ASG-22ME, enfortumab-vedotin-ejfv) Astellas / Pfizer (Seagen)·Nectin-4 201 trials·t½ ADC ~3.4 days; free MMAE ~2.4 days | datopotamab deruxtecan (Datroway, DS-1062, Dato-DXd, datopotamab-deruxtecan-dlnk) Daiichi Sankyo / AstraZeneca·TROP2 50 trials·t½ ADC ~6 days; released DXd cleared rapidly | ||
|---|---|---|---|---|
Overview Program | Padcev (enfortumab vedotin) | Datroway (datopotamab deruxtecan) | Kymriah (tisagenlecleucel) | Imdelltra (tarlatamab) |
Overview Company | Astellas / Pfizer (Seagen) | Daiichi Sankyo / AstraZeneca | Novartis | Amgen |
Overview Modality | ADC | ADC | CGT | ANTIBODY |
Overview Target | Nectin-4 | TROP2 | CD19 | DLL3 × CD3 |
Overview Indication | Locally advanced or metastatic urothelial carcinoma | HR+/HER2− breast cancer; EGFR-mutated non-small cell lung cancer | ALL, DLBCL, FL | Extensive-stage small cell lung cancer after platinum-based chemotherapy |
Overview Phase | APPROVED | APPROVED | APPROVED | APPROVED |
Overview Status | APPROVED | APPROVED | APPROVED | APPROVED |
Overview Content status | Curated Core | Curated Core | Curated Core | Curated Core |
Overview Data Confidence | Data Confidence · High | Data Confidence · High | Data Confidence · High | Data Confidence · High |
Overview Development Signal | Development Signal · Established | Development Signal · Established | Development Signal · Established | Development Signal · Established |
Overview Approval status | FDA approved | FDA approved | FDA approved | FDA approved |
Positioning Key differentiator | Nectin-4 is near-uniformly expressed in urothelial carcinoma, giving an unusually clean tumor-selective target in that tissue. | Same DXd chemistry that made Enhertu work, aimed at TROP2 — high plasma stability with a short-half-life payload to limit systemic exposure. | 4-1BB persistence profile | DLL3 is expressed on ~85–95% of SCLC tumors but almost absent from normal tissue, which is rare for a solid-tumor engager target. |
Positioning Known limitation | Nectin-4 loss, MMAE efflux, and tubulin alterations. | TROP2 loss, SLFN11 status, and topoisomerase I pathway adaptation. | downregulation of naïve T-cell-associated genes (SELL and CD28) | Neuroendocrine-to-non-neuroendocrine plasticity with DLL3 loss; T-cell exhaustion. |
Positioning Development positioning | 1L standard of care in urothelial carcinoma with pembrolizumab. | Second TROP2 ADC to market; competes with Trodelvy on tolerability rather than novelty of target. | — | Only approved DLL3-directed therapy after the failure of rovalpituzumab tesirine. |
Technology Payload | MMAE (monomethyl auristatin E, tubulin inhibitor) | DXd (exatecan derivative, topoisomerase I inhibitor) | — | — |
Technology Linker | Protease-cleavable mc-vc-PAB, DAR ~3.8 | Tetrapeptide-based cleavable maleimide linker, DAR ~4 | — | — |
Technology DAR | DAR 3.8 | DAR 4 | — | — |
Technology Vector | — | — | Lentivirus | — |
MoA Mechanism | Binds Nectin-4 on urothelial tumor cells, internalizes, and releases MMAE after cathepsin B cleavage; microtubule disruption arrests mitosis and triggers apoptosis. | Anti-TROP2 antibody delivers DXd intracellularly after lysosomal linker cleavage; topoisomerase I inhibition drives DNA damage, with membrane-permeable payload producing a bystander effect. | Autologous T cells transduced with lentiviral vector encoding CD19-specific CAR with 4-1BB and CD3ζ signaling domains. Engages CD19+ B cells leading to proliferation and cytotoxicity. | Binds DLL3 on SCLC cells and CD3 on T cells, forcing a cytolytic synapse that kills tumor cells regardless of native TCR specificity. |
MoA Biomarker | Nectin-4 expression is high in urothelial carcinoma; no companion diagnostic required. | TROP2 expression is not a required companion diagnostic; quantitative continuous scoring (QCS) is investigational. | CD19; measurable residual disease in ALL. | DLL3 expression by IHC is not required in the label but tracks with the biology. |
PK/PD Half-life | ADC ~3.4 days; free MMAE ~2.4 days | ADC ~6 days; released DXd cleared rapidly | — | ~11 days (Fc-extended) |
PK/PD Species | Cynomolgus monkey, ORR, PFS, OS | Cynomolgus monkey, Mouse, PFS by BICR, ctDNA and TROP2 QCS exploratory | NHP, CAR T transgene persistence, B-cell aplasia | Cynomolgus monkey, Cytokine kinetics, T-cell margination, radiographic response |
PK/PD Animal (cat.) | Human, NHP, In vitro | Human, Mouse, NHP, In vitro | NHP, In vitro | Human, NHP, In vitro |
PK/PD Experiment | Pharmacokinetic | pd | pharmacodynamic | pharmacokinetic |
Toxicology Species | Cynomolgus monkey, Mouse, Rat | Mouse, Rat, Hamster | NHP, Mouse | Mouse |
Toxicology Animal (cat.) | — | — | Human | — |
Toxicology Major finding | Boxed warning for serious skin reactions including SJS/TEN. Hyperglycemia, peripheral neuropathy, ocular surface toxicity, and pneumonitis also require monitoring. | Stomatitis, dry eye and keratitis, nausea, and alopecia. Interstitial lung disease is a class warning for DXd conjugates and requires prompt steroid intervention. | CRS and neurological events; hypogammaglobulinemia from B-cell aplasia. | Boxed warning for CRS and neurologic toxicity including ICANS. Cytopenia and fatigue are common; step-up dosing with monitoring is mandatory. |
Toxicology CRS | N/A | N/A | CRS ~58–79% in ALL; Grade ≥3 CRS managed with tocilizumab per protocol | CRS ~51–55%, mostly grade 1–2 |
Clinical Safety signal | Boxed warning for serious skin reactions including SJS/TEN. Hyperglycemia, peripheral neuropathy, ocular surface toxicity, and pneumonitis also require monitoring. | Stomatitis, dry eye and keratitis, nausea, and alopecia. Interstitial lung disease is a class warning for DXd conjugates and requires prompt steroid intervention. | CRS and neurological events; hypogammaglobulinemia from B-cell aplasia. | Boxed warning for CRS and neurologic toxicity including ICANS. Cytopenia and fatigue are common; step-up dosing with monitoring is mandatory. |
Clinical Selected reported efficacy | ORR 67.7% | ORR 79% | — | ORR 57.1% |
Clinical Reported ORR | 67.7% (EV + pembrolizumab) | 74% | — | 57.1% |
Clinical Reported PFS | 12.5 mo vs 6.3 mo (chemo) | 4.4 | — | 6.5 |
Clinical Reported OS | 31.5 mo vs 16.1 mo (chemo) | 12.9 | 0 | NA |
Clinical Result source | EV-302 / KEYNOTE-A39 (NCT04223856) | ClinicalTrials.gov NCT04656652 | ClinicalTrials.gov NCT04225676 | ClinicalTrials.gov NCT04885998 |
Clinical Program phase | APPROVED | APPROVED | APPROVED | APPROVED |
Clinical Trial activity | No active/completed counts | No active/completed counts | No active/completed counts | No active/completed counts |
Clinical Trial ref | NCT04223856 | NCT04656652 | NCT04225676 | NCT04885998 |
Preclinical Animal (cat.) | Human, Mouse, In vitro | Mouse, In vitro | — | Mouse, In vitro |
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 (Padcev, ASG-22ME, enfortumab-vedotin-ejfv) Astellas / Pfizer (Seagen)·Nectin-4 201 trials·t½ ADC ~3.4 days; free MMAE ~2.4 days | datopotamab deruxtecan (Datroway, DS-1062, Dato-DXd, datopotamab-deruxtecan-dlnk) Daiichi Sankyo / AstraZeneca·TROP2 50 trials·t½ ADC ~6 days; released DXd cleared rapidly | ||
|---|---|---|---|---|
Overview Program | Padcev (enfortumab vedotin) | Datroway (datopotamab deruxtecan) | Kymriah (tisagenlecleucel) | Imdelltra (tarlatamab) |
Overview Company | Astellas / Pfizer (Seagen) | Daiichi Sankyo / AstraZeneca | Novartis | Amgen |
Overview Modality | ADC | ADC | CGT | ANTIBODY |
Overview Target | Nectin-4 | TROP2 | CD19 | DLL3 × CD3 |
Overview Indication | Locally advanced or metastatic urothelial carcinoma | HR+/HER2− breast cancer; EGFR-mutated non-small cell lung cancer | ALL, DLBCL, FL | Extensive-stage small cell lung cancer after platinum-based chemotherapy |
Overview Phase | APPROVED | APPROVED | APPROVED | APPROVED |
Overview Status | APPROVED | APPROVED | APPROVED | APPROVED |
Overview Content status | Curated Core | Curated Core | Curated Core | Curated Core |
Overview Data Confidence | Data Confidence · High | Data Confidence · High | Data Confidence · High | Data Confidence · High |
Overview Development Signal | Development Signal · Established | Development Signal · Established | Development Signal · Established | Development Signal · Established |
Overview Approval status | FDA approved | FDA approved | FDA approved | FDA approved |
Positioning Key differentiator | Nectin-4 is near-uniformly expressed in urothelial carcinoma, giving an unusually clean tumor-selective target in that tissue. | Same DXd chemistry that made Enhertu work, aimed at TROP2 — high plasma stability with a short-half-life payload to limit systemic exposure. | 4-1BB persistence profile | DLL3 is expressed on ~85–95% of SCLC tumors but almost absent from normal tissue, which is rare for a solid-tumor engager target. |
Positioning Known limitation | Nectin-4 loss, MMAE efflux, and tubulin alterations. | TROP2 loss, SLFN11 status, and topoisomerase I pathway adaptation. | downregulation of naïve T-cell-associated genes (SELL and CD28) | Neuroendocrine-to-non-neuroendocrine plasticity with DLL3 loss; T-cell exhaustion. |
Positioning Development positioning | 1L standard of care in urothelial carcinoma with pembrolizumab. | Second TROP2 ADC to market; competes with Trodelvy on tolerability rather than novelty of target. | — | Only approved DLL3-directed therapy after the failure of rovalpituzumab tesirine. |
Technology Payload | MMAE (monomethyl auristatin E, tubulin inhibitor) | DXd (exatecan derivative, topoisomerase I inhibitor) | — | — |
Technology Linker | Protease-cleavable mc-vc-PAB, DAR ~3.8 | Tetrapeptide-based cleavable maleimide linker, DAR ~4 | — | — |
Technology DAR | DAR 3.8 | DAR 4 | — | — |
Technology Vector | — | — | Lentivirus | — |
MoA Mechanism | Binds Nectin-4 on urothelial tumor cells, internalizes, and releases MMAE after cathepsin B cleavage; microtubule disruption arrests mitosis and triggers apoptosis. | Anti-TROP2 antibody delivers DXd intracellularly after lysosomal linker cleavage; topoisomerase I inhibition drives DNA damage, with membrane-permeable payload producing a bystander effect. | Autologous T cells transduced with lentiviral vector encoding CD19-specific CAR with 4-1BB and CD3ζ signaling domains. Engages CD19+ B cells leading to proliferation and cytotoxicity. | Binds DLL3 on SCLC cells and CD3 on T cells, forcing a cytolytic synapse that kills tumor cells regardless of native TCR specificity. |
MoA Biomarker | Nectin-4 expression is high in urothelial carcinoma; no companion diagnostic required. | TROP2 expression is not a required companion diagnostic; quantitative continuous scoring (QCS) is investigational. | CD19; measurable residual disease in ALL. | DLL3 expression by IHC is not required in the label but tracks with the biology. |
PK/PD Half-life | ADC ~3.4 days; free MMAE ~2.4 days | ADC ~6 days; released DXd cleared rapidly | — | ~11 days (Fc-extended) |
PK/PD Species | Cynomolgus monkey, ORR, PFS, OS | Cynomolgus monkey, Mouse, PFS by BICR, ctDNA and TROP2 QCS exploratory | NHP, CAR T transgene persistence, B-cell aplasia | Cynomolgus monkey, Cytokine kinetics, T-cell margination, radiographic response |
PK/PD Animal (cat.) | Human, NHP, In vitro | Human, Mouse, NHP, In vitro | NHP, In vitro | Human, NHP, In vitro |
PK/PD Experiment | Pharmacokinetic | pd | pharmacodynamic | pharmacokinetic |
Toxicology Species | Cynomolgus monkey, Mouse, Rat | Mouse, Rat, Hamster | NHP, Mouse | Mouse |
Toxicology Animal (cat.) | — | — | Human | — |
Toxicology Major finding | Boxed warning for serious skin reactions including SJS/TEN. Hyperglycemia, peripheral neuropathy, ocular surface toxicity, and pneumonitis also require monitoring. | Stomatitis, dry eye and keratitis, nausea, and alopecia. Interstitial lung disease is a class warning for DXd conjugates and requires prompt steroid intervention. | CRS and neurological events; hypogammaglobulinemia from B-cell aplasia. | Boxed warning for CRS and neurologic toxicity including ICANS. Cytopenia and fatigue are common; step-up dosing with monitoring is mandatory. |
Toxicology CRS | N/A | N/A | CRS ~58–79% in ALL; Grade ≥3 CRS managed with tocilizumab per protocol | CRS ~51–55%, mostly grade 1–2 |
Clinical Safety signal | Boxed warning for serious skin reactions including SJS/TEN. Hyperglycemia, peripheral neuropathy, ocular surface toxicity, and pneumonitis also require monitoring. | Stomatitis, dry eye and keratitis, nausea, and alopecia. Interstitial lung disease is a class warning for DXd conjugates and requires prompt steroid intervention. | CRS and neurological events; hypogammaglobulinemia from B-cell aplasia. | Boxed warning for CRS and neurologic toxicity including ICANS. Cytopenia and fatigue are common; step-up dosing with monitoring is mandatory. |
Clinical Selected reported efficacy | ORR 67.7% | ORR 79% | — | ORR 57.1% |
Clinical Reported ORR | 67.7% (EV + pembrolizumab) | 74% | — | 57.1% |
Clinical Reported PFS | 12.5 mo vs 6.3 mo (chemo) | 4.4 | — | 6.5 |
Clinical Reported OS | 31.5 mo vs 16.1 mo (chemo) | 12.9 | 0 | NA |
Clinical Result source | EV-302 / KEYNOTE-A39 (NCT04223856) | ClinicalTrials.gov NCT04656652 | ClinicalTrials.gov NCT04225676 | ClinicalTrials.gov NCT04885998 |
Clinical Program phase | APPROVED | APPROVED | APPROVED | APPROVED |
Clinical Trial activity | No active/completed counts | No active/completed counts | No active/completed counts | No active/completed counts |
Clinical Trial ref | NCT04223856 | NCT04656652 | NCT04225676 | NCT04885998 |
Preclinical Animal (cat.) | Human, Mouse, In vitro | Mouse, In vitro | — | Mouse, In vitro |
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