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 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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- Filtering will only apply to rows that are already loaded on the page, filtering has no impact on query parameters
- Use quotes to match a longer phrase which contains spaces "mtor c1483f"
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- Click on any column header arrows to sort by that column
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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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