타깃 · 모달리티 · 임상 근거 · 비임상 맥락으로 최대 5개 프로그램을 나란히 비교합니다. · 자동 수집 갱신 권장 · 9월 2일
현재 선택: 2개 · 임상 갱신 필요 2개
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 | sacituzumab govitecan-hziy (Trodelvy, IMMU-132, sacituzumab-govitecan-hziy) Gilead / Immunomedics·TROP2 242 trials | datopotamab deruxtecan-dlnk (Datroway, DS-1062, Dato-DXd) Daiichi Sankyo / AstraZeneca·TROP2 50 trials |
|---|---|---|
Overview Program | Trodelvy (sacituzumab govitecan-hziy) | Datroway (datopotamab deruxtecan-dlnk) |
Overview Company | Gilead / Immunomedics | Daiichi Sankyo / AstraZeneca |
Overview Modality | ADC | ADC |
Overview Target | TROP2 | TROP2 |
Overview Indication | TNBC: regimen-specific first-line and previously treated indications; HR-positive/HER2-negative breast cancer after specified prior therapies. Consult current US label. | HR-positive/HER2-negative breast cancer after specified prior therapies; EGFR-mutated NSCLC after specified prior therapies; first-line TNBC unsuitable for PD-1/PD-L1 therapy. Consult current US label. |
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 | Very high DAR plus a deliberately unstable linker — extracellular SN-38 release gives bystander killing in TROP2-heterogeneous tumors. | Same DXd chemistry that made Enhertu work, aimed at TROP2 — high plasma stability with a short-half-life payload to limit systemic exposure. |
Positioning Known limitation | TROP2 downregulation, TOP1 mutation, and ABC-transporter payload efflux. | TROP2 loss, SLFN11 status, and topoisomerase I pathway adaptation. |
Positioning Development positioning | Regimen-specific; includes 1L TNBC indications from June 2026 | Indication-specific; includes 1L TNBC unsuitable for PD-1/PD-L1 therapy |
Technology Payload | SN-38 (topoisomerase I inhibitor) | DXd (exatecan derivative, topoisomerase I inhibitor) |
Technology Linker | Hydrolyzable CL2A, DAR ~7.6 | Tetrapeptide-based cleavable maleimide linker, DAR ~4 |
Technology DAR | DAR 7.6 | DAR 4 |
MoA Mechanism | Anti-TROP2 antibody binds and internalizes; the hydrolyzable linker releases SN-38 both intracellularly and in the tumor microenvironment, inhibiting topoisomerase I and causing lethal DNA double-strand breaks. | Anti-TROP2 antibody delivers DXd intracellularly after lysosomal linker cleavage; topoisomerase I inhibition drives DNA damage, with membrane-permeable payload producing a bystander effect. |
MoA Biomarker | TROP2 is broadly expressed in epithelial tumors; no companion diagnostic is required in the label. | TROP2 expression is not a required companion diagnostic; quantitative continuous scoring (QCS) is investigational. |
Toxicology Species | Cynomolgus monkey, Hamster | Rat, Hamster |
Toxicology Major finding | Boxed warning for severe neutropenia and severe diarrhea. Nausea, alopecia, fatigue, and rare hypersensitivity are common. | Stomatitis, dry eye and keratitis, nausea, and alopecia. Interstitial lung disease is a class warning for DXd conjugates and requires prompt steroid intervention. |
Toxicology CRS | N/A | N/A |
Clinical Safety signal | Boxed warning for severe neutropenia and severe diarrhea. Nausea, alopecia, fatigue, and rare hypersensitivity are common. | Stomatitis, dry eye and keratitis, nausea, and alopecia. Interstitial lung disease is a class warning for DXd conjugates and requires prompt steroid intervention. |
Clinical Selected reported efficacy | ORR 50% | ORR 64% |
Clinical Reported ORR | 50% vs 47% (chemotherapy) | 64% vs 30% (chemotherapy) |
Clinical Reported PFS | 9.7 months vs 6.9 months (chemotherapy) | 10.8 months vs 5.6 months (chemotherapy) |
Clinical Reported OS | Immature in FDA approval analysis | 23.7 months vs 18.7 months (chemotherapy) |
Clinical Result source | FDA approval report 2026-06-24 — ASCENT-03 (NCT05382299) | FDA approval report 2026-05-22 — TROPION-Breast02 (NCT05374512) |
Clinical Program phase | APPROVED | APPROVED |
Clinical Trial activity | No active/completed counts | No active/completed counts |
Clinical Trial ref | NCT05382299 | NCT05374512 |
Preclinical Animal (cat.) | Mouse | 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
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 | sacituzumab govitecan-hziy (Trodelvy, IMMU-132, sacituzumab-govitecan-hziy) Gilead / Immunomedics·TROP2 242 trials | datopotamab deruxtecan-dlnk (Datroway, DS-1062, Dato-DXd) Daiichi Sankyo / AstraZeneca·TROP2 50 trials |
|---|---|---|
Overview Program | Trodelvy (sacituzumab govitecan-hziy) | Datroway (datopotamab deruxtecan-dlnk) |
Overview Company | Gilead / Immunomedics | Daiichi Sankyo / AstraZeneca |
Overview Modality | ADC | ADC |
Overview Target | TROP2 | TROP2 |
Overview Indication | TNBC: regimen-specific first-line and previously treated indications; HR-positive/HER2-negative breast cancer after specified prior therapies. Consult current US label. | HR-positive/HER2-negative breast cancer after specified prior therapies; EGFR-mutated NSCLC after specified prior therapies; first-line TNBC unsuitable for PD-1/PD-L1 therapy. Consult current US label. |
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 | Very high DAR plus a deliberately unstable linker — extracellular SN-38 release gives bystander killing in TROP2-heterogeneous tumors. | Same DXd chemistry that made Enhertu work, aimed at TROP2 — high plasma stability with a short-half-life payload to limit systemic exposure. |
Positioning Known limitation | TROP2 downregulation, TOP1 mutation, and ABC-transporter payload efflux. | TROP2 loss, SLFN11 status, and topoisomerase I pathway adaptation. |
Positioning Development positioning | Regimen-specific; includes 1L TNBC indications from June 2026 | Indication-specific; includes 1L TNBC unsuitable for PD-1/PD-L1 therapy |
Technology Payload | SN-38 (topoisomerase I inhibitor) | DXd (exatecan derivative, topoisomerase I inhibitor) |
Technology Linker | Hydrolyzable CL2A, DAR ~7.6 | Tetrapeptide-based cleavable maleimide linker, DAR ~4 |
Technology DAR | DAR 7.6 | DAR 4 |
MoA Mechanism | Anti-TROP2 antibody binds and internalizes; the hydrolyzable linker releases SN-38 both intracellularly and in the tumor microenvironment, inhibiting topoisomerase I and causing lethal DNA double-strand breaks. | Anti-TROP2 antibody delivers DXd intracellularly after lysosomal linker cleavage; topoisomerase I inhibition drives DNA damage, with membrane-permeable payload producing a bystander effect. |
MoA Biomarker | TROP2 is broadly expressed in epithelial tumors; no companion diagnostic is required in the label. | TROP2 expression is not a required companion diagnostic; quantitative continuous scoring (QCS) is investigational. |
Toxicology Species | Cynomolgus monkey, Hamster | Rat, Hamster |
Toxicology Major finding | Boxed warning for severe neutropenia and severe diarrhea. Nausea, alopecia, fatigue, and rare hypersensitivity are common. | Stomatitis, dry eye and keratitis, nausea, and alopecia. Interstitial lung disease is a class warning for DXd conjugates and requires prompt steroid intervention. |
Toxicology CRS | N/A | N/A |
Clinical Safety signal | Boxed warning for severe neutropenia and severe diarrhea. Nausea, alopecia, fatigue, and rare hypersensitivity are common. | Stomatitis, dry eye and keratitis, nausea, and alopecia. Interstitial lung disease is a class warning for DXd conjugates and requires prompt steroid intervention. |
Clinical Selected reported efficacy | ORR 50% | ORR 64% |
Clinical Reported ORR | 50% vs 47% (chemotherapy) | 64% vs 30% (chemotherapy) |
Clinical Reported PFS | 9.7 months vs 6.9 months (chemotherapy) | 10.8 months vs 5.6 months (chemotherapy) |
Clinical Reported OS | Immature in FDA approval analysis | 23.7 months vs 18.7 months (chemotherapy) |
Clinical Result source | FDA approval report 2026-06-24 — ASCENT-03 (NCT05382299) | FDA approval report 2026-05-22 — TROPION-Breast02 (NCT05374512) |
Clinical Program phase | APPROVED | APPROVED |
Clinical Trial activity | No active/completed counts | No active/completed counts |
Clinical Trial ref | NCT05382299 | NCT05374512 |
Preclinical Animal (cat.) | Mouse | Mouse, In vitro |
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