Therapy Detail

Therapy Name DS-8201a
Therapy Description

DS-8201a is an antibody-drug conjugate comprising an anti-ERBB2 (HER2) antibody linked to a derivative of the topoisomerase inhibitor DX-8951, which delivers the cytotoxic agent to ERBB2 (HER2)-expressing tumor cells, potentially resulting in decreased growth of tumors, including tumors with low ERBB2 (HER2) expression (PMID: 27026201).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
DS-8201a trastuzumab deruxtecan|DS-8201 HER2 (ERBB2) Antibody 26 DS-8201a is an antibody-drug conjugate comprising an anti-ERBB2 (HER2) antibody linked to a derivative of the topoisomerase inhibitor DX-8951, which delivers the cytotoxic agent to ERBB2 (HER2)-expressing tumor cells, potentially resulting in decreased growth of tumors, including tumors with low ERBB2 (HER2) expression (PMID: 27026201).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
ERBB2 positive breast adenocarcinoma sensitive DS-8201a Preclinical - Cell culture Actionable In a preclinical study, DS-8201 inhibited growth of an ERBB2 (HER2)-positive breast adenocarcinoma cell line in culture (PMID: 27026201). 27026201
ERBB2 positive stomach cancer sensitive DS-8201a Preclinical - Pdx & cell culture Actionable In a preclinical study, DS-8201 inhibited growth of a ERBB2 (HER2)-positive gastric carcinoma cell line in culture and in xenograft models, and induced tumor regression in a patient-derived xenograft (PDX) model of ERBB2 (HER2)-positive gastric cancer (PMID: 27026201). 27026201
ERBB2 positive pancreatic cancer sensitive DS-8201a Preclinical - Cell line xenograft Actionable In a preclinical study, DS-8201a inhibited tumor growth in a pancreatic cancer cell line xenograft model with low ERBB2 (HER2) expression (PMID: 27026201). 27026201
ERBB2 positive Advanced Solid Tumor predicted - sensitive DS-8201a Phase I Actionable In a Phase I trial, treatment with DS-8201a was well-tolerated and resulted in an overall response rate (ORR) of 38% (19/50) and disease control rate (DCR) of 90% (45/50) in patients with ERBB2 (HER2)-expressing solid tumors, and an ORR of 29% (4/14) and DCR of 93% (13/14) in patients with low ERBB2 (HER2) expression (J Clin Oncol 35, 2017 (suppl; abstr 108)). detail...
ERBB2 positive salivary gland cancer predicted - sensitive DS-8201a Phase I Actionable In a Phase I trial, treatment with DS-8201a resulted in a partial response in 50% (2/4) of evaluable patients with salivary gland cancer and ERBB2 (HER2) expression (Ann Oncol 2017, Vol 28, Suppl 5, Abstract # 409P; NCT02564900). detail...
ERBB2 positive colorectal cancer predicted - sensitive DS-8201a Phase I Actionable In a Phase I trial, treatment with DS-8201a resulted in an objective response rate of 25% (3/12) and disease control rate of 83.3% (10/12) in evaluable patients with Erbbe (Her2)-expressing colorectal cancer (Annals of Oncology (2018) 29 (suppl_8): viii150-viii204; NCT02564900). detail...
ERBB2 positive breast cancer sensitive DS-8201a Preclinical - Pdx & cell culture Actionable In a preclinical study, DS-8201 inhibited growth of ERBB2 (HER2)-positive breast cancer cell lines in culture and xenograft models, and demonstrated antitumor activity in patient-derived xenograft (PDX) models of ERBB2 (HER2)-positive breast cancer, including models with low ERBB2 (HER2) expression (PMID: 27026201). 27026201
Clinical Trial Phase Therapies Title Recruitment Status
NCT02564900 Phase I DS-8201a Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors Active, not recruiting
NCT03529110 Phase III DS-8201a trastuzumab emtansine DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane Recruiting
NCT03384940 Phase II DS-8201a DS-8201a in Human Epidermal Growth Factor Receptor2 (HER2)-Expressing Colorectal Cancer Recruiting
NCT03505710 Phase II DS-8201a DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer Recruiting
NCT03248492 Phase II DS-8201a DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer Active, not recruiting
NCT03523585 Phase III DS-8201a Lapatinib + Capecitabine Capecitabine + Trastuzumab DS-8201a Versus Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Pretreated With Prior Standard of Care Recruiting
NCT03734029 Phase III DS-8201a nab-paclitaxel Capecitabine Paclitaxel Gemcitabine Eribulin DS-8201a Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04] Recruiting