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Therapy Name Trastuzumab deruxtecan
Synonyms
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
Trastuzumab deruxtecan Enhertu DS-8201|DS8201a|T-DXd|DS-8201a|fam-trastuzumab deruxtecan-nxki HER2 (ERBB2) Antibody 50 Enhertu (trastuzumab deruxtecan) 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). Enhertu (fam-trastuzumab deruxtecan-nxki) is FDA approved for use in patients with ERBB2 (HER2)-positive breast cancer who have received two or more anti-HER2 therapies previously, and in patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma who have received a prior trastuzumab-based therapy (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
ERBB2 positive stomach cancer sensitive Trastuzumab deruxtecan Preclinical - Pdx & cell culture Actionable In a preclinical study, Enhertu (fam-trastuzumab deruxtecan-nxki) 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 amp gastroesophageal junction adenocarcinoma sensitive Trastuzumab deruxtecan FDA approved Actionable In a Phase II trial (DESTINY-Gastric01) that supported FDA approval, Enhertu (fam-trastuzumab deruxtecan-nxki) treatment improved objective response rate (51%, 61/119 vs 14%, 8/56, p<0.0001) and overall survival (12.5 vs 8.4 mo, HR=0.59, p=0.01) compared to chemotherapy in patients with advanced gastric or gastroesophageal junction adenocarcinoma with Erbb2 (Her2)-positive (IHC 3+ or IHC 2+ plus ISH +), whose have received a prior trastuzumab-based therapy (PMID: 32469182; NCT03329690). 32469182 detail...
ERBB2 positive lung non-small cell carcinoma predicted - sensitive Trastuzumab deruxtecan Phase I Actionable n a Phase I trial, treatment with Enhertu (fam-trastuzumab deruxtecan-nxki) in patients with ERBB2 (HER2)-expressing or ERBB2 (HER2)-mutant non-small cell lung cancer resulted in an objective response rate of 55.6% (10/18), median duration of response o 10.7 months, and median progression-free survival of 11.3 months (PMID: 32213540; NCT02564900). 32213540
ERBB2 over exp salivary gland cancer sensitive Trastuzumab deruxtecan Guideline Actionable Enhertu (trastuzumab deruxtecan) is included in guidelines for patients with recurrent, unresectable, or metastatic salivary gland tumors that are ERBB2 (HER2)-positive (overexpression or amplification), as defined by the ASCO/CAP guidelines for ERBB2 (HER2) testing (NCCN.org). detail...
ERBB2 L755S ERBB2 amp Her2-receptor positive breast cancer predicted - sensitive Trastuzumab deruxtecan Case Reports/Case Series Actionable In a clinical case study, a patient with previously treated metastatic hormone receptor (ESR1/PGR)-positive, ERBB2 (HER2)-positive breast invasive ductal carcinoma harboring ERBB2 (HER2) L755S with ERBB2 (HER2) amplification achieved a rapid and ongoing response to treatment with Enhertu (trastuzumab deruxtecan), including shrinkage of primary and metastatic lesions (PMID: 33559918). 33559918
ERBB2 positive Advanced Solid Tumor predicted - sensitive Trastuzumab deruxtecan Phase I Actionable In a Phase I trial, treatment with Enhertu (fam-trastuzumab deruxtecan-nxki) demonstrated safety in patients with non-breast/non-gastric ERBB2 (HER2)-expressing or ERBB2 (HER2)-mutant solid tumors and resulted in an objective response rate of 28.3% (17/60), median duration of response of 11.5 months, median progression-free survival of 7.2 months, and median overall survival of 23.4 months (PMID: 32213540; NCT02564900). 32213540
ERBB2 amp salivary gland cancer sensitive Trastuzumab deruxtecan Guideline Actionable Enhertu (trastuzumab deruxtecan) is included in guidelines for patients with recurrent, unresectable, or metastatic salivary gland tumors that are ERBB2 (HER2)-positive (overexpression or amplification), as defined by the ASCO/CAP guidelines for ERBB2 (HER2) testing (NCCN.org). detail...
ERBB2 amp gastric adenocarcinoma sensitive Trastuzumab deruxtecan FDA approved Actionable In a Phase II trial (DESTINY-Gastric01) that supported FDA approval, Enhertu (fam-trastuzumab deruxtecan-nxki) treatment improved objective response rate (51%, 61/119 vs 14%, 8/56, p<0.0001) and overall survival (12.5 vs 8.4 mo, HR=0.59, p=0.01) compared to chemotherapy in patients with advanced gastric or gastroesophageal junction adenocarcinoma with Erbb2 (Her2)-positive (IHC 3+ or IHC 2+ plus ISH +), whose have received a prior trastuzumab-based therapy (PMID: 32469182; NCT03329690). detail... 32469182
ERBB2 act mut lung adenocarcinoma sensitive Trastuzumab deruxtecan Phase II Actionable In a Phase II trial (DESTINY-Lung01), Enhertu (trastuzumab deruxtecan) treatment resulted in an objective response rate of 61.9% (26/42) and a median progression free survival of 14 months in patients with metastatic non-small cell lung carcinoma harboring ERBB2 activating mutations (J Clin Oncol 38: 2020 (suppl; abstr 9504); NCT03505710). detail...
ERBB2 S310F ERBB2 amp lung cancer predicted - sensitive Trastuzumab deruxtecan Case Reports/Case Series Actionable In a Phase II trial, a lung cancer patient harboring ERBB2 (HER2) amplification and ERBB2 (HER2) S310F who initially reponded to Kadcyla (ado-trastuzumab emtansine) treatment for 4 months, but then progressed, was treated with Enhertu (trastuzumab deruxtecan), and demonstrated a partial reponse with 70% tumor shrinkage, which lasted for one year (PMID: 32213539; NCT02564900). 32213539
ERBB2 S310F ERBB2 amp lung cancer predicted - sensitive Trastuzumab deruxtecan Preclinical - Pdx Actionable In a preclinical study, Enhertu (trastuzumab deruxtecan) treatment resulted in complete tumor regression in a patient-derived xenograft (PDX) model of lung cancer harboring ERBB2 (HER2) amplification and ERBB2 (HER2) S310F (PMID: 32213539). 32213539
ERBB2 over exp Her2-receptor positive breast cancer sensitive Trastuzumab deruxtecan FDA approved Actionable In a Phase II trial (DESTINY-Breast01) that supported FDA approval, Enhertu (fam-trastuzumab deruxtecan-nxki) treatment resulted in an objective response rate of 60.9% (112/184) in patients with unresectable or metastatic ERBB2 (HER2)-positive (IHC 3+ or FISH +) breast cancer who have received two or more prior anti-HER2 therapies, with a median response duration of 14.8 months and a median progression-free survival of 16.4 months (PMID: 31825192; NCT03248492). detail... 31825192
ERBB2 over exp Her2-receptor positive breast cancer sensitive Trastuzumab deruxtecan Guideline Actionable Enhertu (fam-trastuzumab deruxtecan-nxki) is included in guidelines as systemic therapy for patients with recurrent or metastatic hormone receptor-positive (ER and/or PR) or negative, ERBB2 (HER2)-positive breast cancer (NCCN.org). detail...
ERBB2 amp Her2-receptor positive breast cancer sensitive Trastuzumab deruxtecan Guideline Actionable Enhertu (fam-trastuzumab deruxtecan-nxki) is included in guidelines as systemic therapy for patients with recurrent or metastatic hormone receptor-positive (ER and/or PR) or negative, ERBB2 (HER2)-positive breast cancer (NCCN.org). detail...
ERBB2 amp Her2-receptor positive breast cancer sensitive Trastuzumab deruxtecan FDA approved Actionable In a Phase II trial (DESTINY-Breast01) that supported FDA approval, Enhertu (fam-trastuzumab deruxtecan-nxki) treatment resulted in an objective response rate of 60.9% (112/184) in patients with unresectable or metastatic ERBB2 (HER2)-positive (IHC 3+ or FISH +) breast cancer who have received two or more prior anti-HER2 therapies, with a median response duration of 14.8 months and a median progression-free survival of 16.4 months (PMID: 31825192; NCT03248492). detail... 31825192
ERBB2 positive salivary gland cancer predicted - sensitive Trastuzumab deruxtecan Phase I Actionable In a Phase I trial, treatment with Enhertu (fam-trastuzumab deruxtecan-nxki) in patients with non-breast/non-gastric ERBB2 (HER2)-expressing or ERBB2 (HER2)-mutant solid tumors resulted in an objective response rate of 27.3% (6/22) and median progression-free survival of 11.0 months in the subgroup with cancers other than non-small cell lung cancer or colorectal cancer, including responses among patients with ERBB2 (HER)-expressing or amplified salivary gland cancer (PMID: 32213540; NCT02564900). 32213540
ERBB2 positive pancreatic cancer sensitive Trastuzumab deruxtecan Preclinical - Cell line xenograft Actionable In a preclinical study, Enhertu (fam-trastuzumab deruxtecan-nxki) inhibited tumor growth in a pancreatic cancer cell line xenograft model with low ERBB2 (HER2) expression (PMID: 27026201). 27026201
ERBB2 positive colorectal cancer predicted - sensitive Trastuzumab deruxtecan Phase I Actionable In a Phase I trial, treatment with Enhertu (fam-trastuzumab deruxtecan-nxki) resulted in an objective response rate (ORR) of 5% (1/20) and median progression-free survival of 4.0 months in patients with Erbb2 (Her2)-expressing colorectal cancer, with an ORR of 11.1% (1/9) and confirmed disease control rate of 100% (9/9) in patients with Erbb2 (Her2) expression of IHC 3+ (PMID: 32213540; NCT02564900). 32213540
ERBB2 positive breast adenocarcinoma sensitive Trastuzumab deruxtecan Preclinical - Cell culture Actionable In a preclinical study, Enhertu (fam-trastuzumab deruxtecan-nxki) inhibited growth of an ERBB2 (HER2)-positive breast adenocarcinoma cell line in culture (PMID: 27026201). 27026201
ERBB2 over exp gastric adenocarcinoma sensitive Trastuzumab deruxtecan FDA approved Actionable In a Phase II trial (DESTINY-Gastric01) that supported FDA approval, Enhertu (fam-trastuzumab deruxtecan-nxki) treatment improved objective response rate (51%, 61/119 vs 14%, 8/56, p<0.0001) and overall survival (12.5 vs 8.4 mo, HR=0.59, p=0.01) compared to chemotherapy in patients with advanced gastric or gastroesophageal junction adenocarcinoma with Erbb2 (Her2)-positive (IHC 3+ or IHC 2+ plus ISH +), whose have received a prior trastuzumab-based therapy (PMID: 32469182; NCT03329690). detail... 32469182
ERBB2 positive Her2-receptor positive breast cancer sensitive Trastuzumab deruxtecan Preclinical - Pdx & cell culture Actionable In a preclinical study, Enhertu (fam-trastuzumab deruxtecan-nxki) 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
ERBB2 over exp gastroesophageal junction adenocarcinoma sensitive Trastuzumab deruxtecan FDA approved Actionable In a Phase II trial (DESTINY-Gastric01) that supported FDA approval, Enhertu (fam-trastuzumab deruxtecan-nxki) treatment improved objective response rate (51%, 61/119 vs 14%, 8/56, p<0.0001) and overall survival (12.5 vs 8.4 mo, HR=0.59, p=0.01) compared to chemotherapy in patients with advanced gastric or gastroesophageal junction adenocarcinoma with Erbb2 (Her2)-positive (IHC 3+ or IHC 2+ plus ISH +), whose have received a prior trastuzumab-based therapy (PMID: 32469182; NCT03329690). 32469182 detail...
ERBB2 act mut lung non-small cell carcinoma predicted - sensitive Trastuzumab deruxtecan Phase I Actionable In a Phase I trial, treatment with Enhertu (fam-trastuzumab deruxtecan-nxki) resulted in an objective response rate (ORR) of 72.7% (8/11, all partial responses), disease control rate of 90.9% (10/11). median duration of response of 9.9 months, and median progression-free survival of 11.3 months in patients with non-small cell lung cancer harboring an ERBB2 (HER2) mutation (PMID: 32213540; NCT02564900). 32213540

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT04294628 Phase I Trastuzumab deruxtecan Testing the Biological Effects of DS-8201a on Patients With Advanced Cancer Recruiting USA 0
NCT04014075 Phase II Trastuzumab deruxtecan DS-8201a in HER2-positive Gastric Cancer That Cannot Be Surgically Removed or Has Spread (DESTINY-Gastric02) Active, not recruiting USA 4
NCT02564900 Phase I Trastuzumab deruxtecan Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors Active, not recruiting USA 1
NCT04494425 Phase III Capecitabine Nab-paclitaxel Trastuzumab deruxtecan Paclitaxel Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer (DB-06) Recruiting USA | CAN 22
NCT04616560 Phase II Trastuzumab deruxtecan Trastuzumab Deruxtecan for the Treatment of HER2+ Newly Diagnosed or Recurrent Osteosarcoma Recruiting USA 0
NCT03734029 Phase III Trastuzumab deruxtecan Nab-paclitaxel Capecitabine Paclitaxel Gemcitabine Eribulin Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04] Active, not recruiting USA | CAN 18
NCT04744831 Phase II Trastuzumab deruxtecan Trastuzumab Deruxtecan in Participants With HER2-overexpressing Advanced or Metastatic Colorectal Cancer (DESTINY-CRC02) Not yet recruiting USA 9
NCT03248492 Phase II Trastuzumab deruxtecan A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1) Active, not recruiting USA | CAN 7
NCT04538742 Phase Ib/II Durvalumab + Trastuzumab deruxtecan Pertuzumab + Trastuzumab deruxtecan Durvalumab + Paclitaxel + Trastuzumab deruxtecan Paclitaxel + Trastuzumab deruxtecan Trastuzumab deruxtecan A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer (DB-07) Recruiting USA 9
NCT03505710 Phase II Trastuzumab deruxtecan DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer Active, not recruiting USA 4
NCT03529110 Phase III Trastuzumab deruxtecan Ado-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 [DESTINY-Breast03] Active, not recruiting USA | CAN 13
NCT03523585 Phase III Trastuzumab deruxtecan Capecitabine + Lapatinib Capecitabine + Trastuzumab DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02] Active, not recruiting USA 14
NCT04482309 Phase II Trastuzumab deruxtecan A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors (DPT02) Recruiting USA | CAN 11
NCT04379596 Phase II Cisplatin + Fluorouracil + Trastuzumab Capecitabine + Oxaliplatin + Trastuzumab Capecitabine + Cisplatin + Trastuzumab Trastuzumab deruxtecan Fluorouracil + Oxaliplatin + Trastuzumab Fluorouracil + Trastuzumab deruxtecan Capecitabine + Trastuzumab deruxtecan Durvalumab + Trastuzumab deruxtecan Fluorouracil + Oxaliplatin + Trastuzumab deruxtecan Capecitabine + Oxaliplatin + Trastuzumab deruxtecan Durvalumab + Fluorouracil + Trastuzumab deruxtecan Capecitabine + Durvalumab + Trastuzumab deruxtecan Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2+ Gastric Cancer (DESTINY-Gastric03) (DG-03) Recruiting USA | CAN 9
NCT03384940 Phase II Trastuzumab deruxtecan DS-8201a in Human Epidermal Growth Factor Receptor2 (HER2)-Expressing Colorectal Cancer (DESTINY-CRC01) Completed USA 4
NCT04553770 Phase II Trastuzumab deruxtecan Anastrozole + Trastuzumab deruxtecan Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer Recruiting USA 0
NCT04639219 Phase II Trastuzumab deruxtecan A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations (DPT01) Recruiting USA 2


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