Therapy Detail
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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 38 | 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 (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| ERBB2 over exp | stomach cancer | predicted - sensitive | Trastuzumab deruxtecan | Phase II | Actionable | In a Phase II trial (DESTINY-Gastric01), 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 cancer or gastroesophageal junction adenocarcinoma with high Erbb2 (Her2) expression (IHC 3+ or IHC 2+ plus ISH +), whose disease progressed after 2 or more prior therapies (PMID: 32469182; NCT03329690). | 32469182 |
| 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 positive | stomach cancer | sensitive | Trastuzumab deruxtecan | Phase II | Actionable | In a Phase II trial (DESTINY-Gastric01), Enhertu (fam-trastuzumab deruxtecan-nxki) treatment improved objective response rate (51.3%, 61/119 vs 14.3%, 8/56, p<0.0001), median progression-free survival (5.6 vs 3.5 mo, HR=0.47, p=0.0003), and overall survival (12.5 vs 8.4 mo, HR=0.59, p=0.0097) compared to chemotherapy in patients with advanced ERBB2 (HER2)-positive gastric cancer or gastroesophageal junction adenocarcinoma (J Clin Oncol 38: 2020 (suppl; abstr 4513); NCT03329690). | detail... |
| ERBB2 positive | salivary gland cancer | predicted - sensitive | Trastuzumab deruxtecan | Phase I | Actionable | In a Phase I trial, treatment with Enhertu (fam-trastuzumab deruxtecan-nxki) 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 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 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 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 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 | gastroesophageal junction adenocarcinoma | predicted - sensitive | Trastuzumab deruxtecan | Phase II | Actionable | In a Phase II trial (DESTINY-Gastric01), Enhertu (fam-trastuzumab deruxtecan-nxki) treatment improved objective response rate (51.3%, 61/119 vs 14.3%, 8/56, p<0.0001), median progression-free survival (5.6 vs 3.5 mo, HR=0.47, p=0.0003), and overall survival (12.5 vs 8.4 mo, HR=0.59, p=0.0097) compared to chemotherapy in patients with advanced ERBB2 (HER2)-positive gastric or gastroesophageal junction adenocarcinoma (J Clin Oncol 38: 2020 (suppl; abstr 4513); NCT03329690). | detail... |
| 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 positive | 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 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). | 31825192 |
| 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 positive | Advanced Solid Tumor | predicted - sensitive | Trastuzumab deruxtecan | Phase I | Actionable | In a Phase I trial, treatment with Enhertu (fam-trastuzumab deruxtecan-nxki) 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 | 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 | gastroesophageal junction adenocarcinoma | predicted - sensitive | Trastuzumab deruxtecan | Phase II | Actionable | In a Phase II trial (DESTINY-Gastric01), 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 cancer or gastroesophageal junction adenocarcinoma with high Erbb2 (Her2) expression (IHC 3+ or IHC 2+ plus ISH +), whose disease progressed after 2 or more prior therapies (PMID: 32469182; NCT03329690). | 32469182 |
| 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 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status |
|---|---|---|---|---|
| NCT03734029 | Phase III | Trastuzumab deruxtecan 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 |
| 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] | Recruiting |
| NCT03248492 | Phase II | Trastuzumab deruxtecan | DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer | Active, not recruiting |
| NCT04014075 | Phase II | Trastuzumab deruxtecan | DS-8201a in HER2-positive Gastric Cancer That Cannot Be Surgically Removed or Has Spread | Recruiting |
| 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) | Not yet recruiting |
| NCT04294628 | Phase I | Trastuzumab deruxtecan | Testing the Biological Effects of DS-8201a on Patients With Advanced Cancer | Recruiting |
| NCT03384940 | Phase II | Trastuzumab deruxtecan | DS-8201a in Human Epidermal Growth Factor Receptor2 (HER2)-Expressing Colorectal Cancer | Active, not recruiting |
| 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 |
| NCT04379596 | Phase Ib/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 |
| NCT02564900 | Phase I | Trastuzumab deruxtecan | Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors | Active, not recruiting |
| NCT04482309 | Phase II | Trastuzumab deruxtecan | A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors (DPT02) | Not yet recruiting |
| NCT03505710 | Phase II | Trastuzumab deruxtecan | DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer | Recruiting |
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