ADCCurated CoreFDAApprovedApproved

datopotamab deruxtecan (Datroway, DS-1062, Dato-DXd, datopotamab-deruxtecan-dlnk)

Daiichi SankyoAstraZeneca

비교

분석

큐레이션 브리핑

한 줄로 읽는 이유

경쟁 포지션: Second TROP2 ADC to market; competes with Trodelvy on tolerability rather than novelty of target.

기전. Anti-TROP2 antibody delivers DXd intracellularly after lysosomal linker cleavage; topoisomerase I inhibition drives DNA damage, with membrane-permeable payload producing a bystander effect.

우선 정리한 핵심 프로그램입니다. 공개 출처가 있는 필드만 표시합니다.

구조화 데이터출처: ClinicalTrials.gov · PubMed · openFDACurated CoreFDA최근 동기화됨

구조화 데이터

개요

임상 2026년 9월 2일 (8일 전)PK/독성 2026년 9월 2일 (8일 전)

TROP2

HR+/HER2− breast cancer; EGFR-mutated non-small cell lung cancer

US, EU, JP

Approved

datroway · datopotamab deruxtecan · Datroway · Dato-DXd · DS-1062 · datopotamab-deruxtecan-dlnk

2026-09-10

Data Confidence · High

Development Signal · Established

Technology

Antibody-drug conjugate

DXd (exatecan derivative, topoisomerase I inhibitor)

Tetrapeptide-based cleavable maleimide linker, DAR ~4

Humanized anti-TROP2 IgG1

Same DXd chemistry that made Enhertu work, aimed at TROP2 — high plasma stability with a short-half-life payload to limit systemic exposure.

구조화 데이터

비교용 포지션

Same DXd chemistry that made Enhertu work, aimed at TROP2 — high plasma stability with a short-half-life payload to limit systemic exposure.

TROP2 loss, SLFN11 status, and topoisomerase I pathway adaptation.

DXd (exatecan derivative, topoisomerase I inhibitor)

Tetrapeptide-based cleavable maleimide linker, DAR ~4

DAR 4

TROP2 · TROP2 expression is not a required companion diagnostic; quantitative continuous scoring (QCS) is investigational.

Stomatitis, ocular surface toxicity, and ILD monitoring

Second TROP2 ADC to market; competes with Trodelvy on tolerability rather than novelty of target.

Target Product Profile (TPP)

Pretreated HR+/HER2− metastatic breast cancer; EGFR-mutated NSCLC after TKI

2L+ after endocrine therapy and chemotherapy

IV

6 mg/kg q3w

ORR ~36% in TROPION-Breast01

Stomatitis, ocular surface toxicity, and ILD monitoring

Second TROP2 ADC to market; competes with Trodelvy on tolerability rather than novelty of target.

Mechanism of Action

Anti-TROP2 antibody delivers DXd intracellularly after lysosomal linker cleavage; topoisomerase I inhibition drives DNA damage, with membrane-permeable payload producing a bystander effect.

antibody-dependent cellular cytotoxicity

Topoisomerase I inhibition and DNA double-strand breaks.

TROP2 expression is not a required companion diagnostic; quantitative continuous scoring (QCS) is investigational.

TROP2 loss, SLFN11 status, and topoisomerase I pathway adaptation.

구조화 데이터

비임상 프로파일

xenograft mouse

Human, cynomolgus

ADC ~6 days; released DXd cleared rapidly

PFS by BICR; ctDNA and TROP2 QCS exploratory

ADC non-clinical strategy

구조화 데이터

임상시험 & 결과

차트 로드 중…

임상 한눈에 보기

  • 50건의 ClinicalTrials.gov 임상 기록
  • Phase·Status 요약은 enrollment 상위 표본 기준입니다
  • 임상시험 탭에서 enrollment 상위 목록을 불러올 수 있습니다
  • Phase: Phase 2 · Phase 3 · Phase 1 · Phase 1, Phase 2
  • Status: Approved for marketing · Recruiting · Active, not recruiting
  • 주요 endpoint: Determine whether adding experimental agents to standard neoadjuvant medications increases the probability of pathologic complete response (pCR) over standard neoadjuvant chemotherapy for each biomarker signature established at trial entry. · Establishing predictive and prognostic indices based on qualification and exploratory markers to predict pCR and residual cancer burden (RCB). · To determine three- and five-year relapse-free survival (RFS) and OS among the treatment arms. · To determine incidence of adverse events (AEs) · serious adverse events (SAEs)
  • 선택한 코호트 보고값: ORR 79%
  • PFS: 4.4
  • 핵심: This study will evaluate the efficacy, safety, and pharmacokinetics of DS-1062a versus docetaxel in participants with pr…

임상시험이 많습니다. 임상시험 탭에서 Phase/Status 필터·검색을 사용하세요.

수집된 임상 필드(phase, status, endpoint 등) 기반 자동 요약입니다. 효능 수치는 선택한 등록 결과이며 전적응증 값이 아닙니다.

개발 타임라인

  1. FDA approval (HR+/HER2− breast cancer)

    APPROVAL · 2025년 1월

  2. Accelerated approval in EGFR-mutated NSCLC

    APPROVAL

출처 및 참고문헌

바이오정보모아는 연구·교육용 과학·의약품 개발 정보입니다. 진료, 진단, 치료 지침, 규제 자문이 아닙니다.

자주 묻는 질문

Datroway (datopotamab deruxtecan)은 어떤 치료제인가요?
Datroway (datopotamab deruxtecan)(Daiichi Sankyo / AstraZeneca)은 TROP2 표적 ADC로, HR+/HER2− breast cancer; EGFR-mutated non-small cell lung cancer 영역에서 개발·상용화 중입니다. 데이터는 바이오정보모아 (BioJungboMoa)에서 ClinicalTrials.gov·openFDA·PubMed 기반으로 정리합니다.
Datroway (datopotamab deruxtecan)의 임상 단계는?
Datroway (datopotamab deruxtecan)은 FDA 승인 또는 승인 단계로 표시되어 있습니다.
비슷한 프로그램과 어떻게 비교하나요?
바이오정보모아 (BioJungboMoa) 비교 페이지에서 PK/PD, 독성, 임상 효능 지표를 나란히 볼 수 있습니다. 동일 타깃·모달리티 프리셋을 함께 참고하세요.

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