Therapy Detail
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| Therapy Name | Trastuzumab deruxtecan |
| Synonyms | |
| Therapy Description |
Enhertu (trastuzumab deruxtecan) is an antibody-drug conjugate (ADC) 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, in patients with ERBB2 (HER2)-low (IHC 1+ or IHC 2+/ISH -) breast cancer received prior chemotherapy, in patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma who have received prior trastuzumab-based therapy, and in patients with non-small cell lung cancer harboring ERBB2 (HER2) activating mutations who have received prior systemic therapy (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Trastuzumab deruxtecan | Enhertu | DS-8201|DS8201a|T-DXd|DS-8201|fam-trastuzumab deruxtecan-nxki|DS-8201a | HER2 (ERBB2) Antibody 72 HER2 (ERBB2) Antibody-Drug Conjugate 27 | Enhertu (trastuzumab deruxtecan) is an antibody-drug conjugate (ADC) 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, in patients with ERBB2 (HER2)-low (IHC 1+ or IHC 2+/ISH -) breast cancer received prior chemotherapy, in patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma who have received prior trastuzumab-based therapy, and in patients with non-small cell lung cancer harboring ERBB2 (HER2) activating mutations who have received prior systemic therapy (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT02564900 | Phase I | Trastuzumab deruxtecan | Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors | Completed | USA | 1 |
| 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 | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS | 6 |
| 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 | ITA | GBR | FRA | ESP | CAN | BEL | 2 |
| NCT05113251 | Phase III | Paclitaxel + Pertuzumab + Trastuzumab + Trastuzumab deruxtecan Trastuzumab deruxtecan Cyclophosphamide + Doxorubicin + Paclitaxel + Pertuzumab + Trastuzumab | Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer | Recruiting | USA | ITA | ESP | DEU | CAN | AUT | 13 |
| NCT05950945 | Phase III | Trastuzumab deruxtecan | Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer | Recruiting | USA | 0 |
| NCT05982678 | Phase II | Trastuzumab deruxtecan | Basket Study for Oligo-metastatic Breast Cancer (ANISE) | Not yet recruiting | NLD | 0 |
| NCT03505710 | Phase II | Trastuzumab deruxtecan | DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer (DESTINY-Lung01) | Active, not recruiting | USA | NLD | FRA | ESP | 1 |
| 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 | ITA | GBR | FRA | ESP | DEU | BEL | AUS | 7 |
| NCT04644237 | Phase II | Trastuzumab deruxtecan | Trastuzumab Deruxtecan in Participants With HER2-mutated Metastatic Non-small Cell Lung Cancer (NSCLC) (DESTINY-LUNG02) | Active, not recruiting | USA | NLD | ITA | FRA | ESP | CAN | AUS | 3 |
| NCT04639219 | Phase II | Trastuzumab deruxtecan | A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations (DPT01) | Active, not recruiting | USA | ITA | FRA | ESP | CAN | BEL | 3 |
| NCT06058988 | Phase II | Trastuzumab deruxtecan | Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer | Recruiting | USA | 0 |
| NCT04482309 | Phase II | Trastuzumab deruxtecan | A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors (DPT02) | Active, not recruiting | USA | NLD | ITA | GBR | ESP | CAN | BEL | AUS | 7 |
| NCT04294628 | Phase I | Trastuzumab deruxtecan | Testing the Biological Effects of DS-8201a on Patients With Advanced Cancer | Active, not recruiting | USA | 0 |
| NCT04744831 | Phase II | Trastuzumab deruxtecan | Trastuzumab Deruxtecan in Participants With HER2-overexpressing Advanced or Metastatic Colorectal Cancer (DESTINY-CRC02) | Active, not recruiting | USA | ITA | GBR | FRA | ESP | BEL | AUS | 3 |
| NCT04784715 | Phase III | Pertuzumab + Trastuzumab deruxtecan Docetaxel + Pertuzumab + Trastuzumab Paclitaxel + Pertuzumab + Trastuzumab Trastuzumab deruxtecan | Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09) | Active, not recruiting | USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | 19 |
| NCT04622319 | Phase III | Trastuzumab deruxtecan Ado-trastuzumab emtansine | A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05) | Active, not recruiting | USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS | 21 |
| NCT05048797 | Phase III | Cisplatin + Pembrolizumab + Pemetrexed Disodium Carboplatin + Pembrolizumab + Pemetrexed Disodium Trastuzumab deruxtecan | A Study to Investigate the Efficacy and Safety of Trastuzumab Deruxtecan as the First Treatment Option for Unresectable, Locally Advanced/Metastatic Non-Small Cell Lung Cancer With HER2 Mutations | Recruiting | USA | NLD | ITA | FRA | ESP | DEU | CAN | BEL | AUT | 11 |
| 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 | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | 11 |
| NCT05704829 | Phase II | Trastuzumab deruxtecan | NeoAdjuvant Therapy With Trastuzumab-deruxtecan Versus Chemotherapy+Trastuzumab+Pertuzumab in HER2+ Early Breast Cancer (ADAPTHER2-IV) | Not yet recruiting | DEU | 0 |
| NCT04739761 | Phase III | Trastuzumab deruxtecan | A Study of T-DXd in Participants With or Without Brain Metastasis Who Have Previously Treated Advanced or Metastatic HER2 Positive Breast Cancer (DESTINY-B12) | Completed | USA | NLD | ITA | GBR | ESP | DEU | CAN | BEL | AUS | 9 |
| NCT05965479 | Phase II | Trastuzumab deruxtecan | Developing ctDNA Guided Adjuvant Therapy for Gastrooesophageal Cancer (DECIPHER) | Recruiting | GBR | 0 |
| NCT03384940 | Phase II | Trastuzumab deruxtecan | DS-8201a in Human Epidermal Growth Factor Receptor2 (HER2)-Expressing Colorectal Cancer (DESTINY-CRC01) | Completed | USA | ITA | GBR | ESP | 1 |
| NCT04420598 | Phase II | Trastuzumab deruxtecan | DS-8201a for trEatment of aBc, BRain Mets, And Her2[+] Disease (DEBBRAH) | Completed | ESP | 1 |
| NCT04616560 | Phase II | Trastuzumab deruxtecan | Trastuzumab Deruxtecan for the Treatment of HER2+ Newly Diagnosed or Recurrent Osteosarcoma | Suspended | USA | 0 |
| NCT05376878 | FDA approved | Trastuzumab Trastuzumab deruxtecan | An Investigational Scan (64Cu-DOTA-Trastuzumab PET/MRI) in Imaging Patients With HER2+ Breast Cancer With Brain Metastasis | Recruiting | USA | 0 |
| NCT05097599 | Phase II | Binimetinib + Encorafenib Trastuzumab deruxtecan Enfortumab vedotin-ejfv Talazoparib Lorlatinib | Strata PATH (Precision Indications for Approved Therapies) (Strata PATH) | Recruiting | USA | 0 |
| NCT04379596 | Phase II | Cisplatin + Fluorouracil + Trastuzumab Capecitabine + Oxaliplatin + Trastuzumab Fluorouracil + Oxaliplatin + Trastuzumab Fluorouracil + Trastuzumab deruxtecan Capecitabine + Trastuzumab deruxtecan Durvalumab + Trastuzumab deruxtecan Fluorouracil + Oxaliplatin + Trastuzumab deruxtecan Pembrolizumab + Trastuzumab deruxtecan Capecitabine + Oxaliplatin + Trastuzumab deruxtecan Fluorouracil + Pembrolizumab + Trastuzumab deruxtecan Durvalumab + Fluorouracil + Trastuzumab deruxtecan Capecitabine + Durvalumab + Trastuzumab deruxtecan Capecitabine + Fluorouracil + Pembrolizumab + Trastuzumab deruxtecan Capecitabine + Fluorouracil + MEDI5752 + Trastuzumab deruxtecan Capecitabine + Pembrolizumab + Trastuzumab + Tucatinib Capecitabine + Cisplatin + Trastuzumab Trastuzumab deruxtecan | Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03) (DG-03) | Recruiting | USA | NLD | ITA | GBR | ESP | DEU | CAN | 7 |
| 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 |
| NCT04704934 | Phase III | Paclitaxel + Ramucirumab Trastuzumab deruxtecan | Trastuzumab Deruxtecan for Subjects With HER2-Positive Gastric Cancer or Gastro-Esophageal Junction Adenocarcinoma After Progression on or After a Trastuzumab-Containing Regimen (DESTINY-Gastric04) | Recruiting | ITA | GBR | FRA | ESP | DEU | BEL | 18 |
| 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) | Active, not recruiting | USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS | 17 |
| NCT05744375 | Phase II | Trastuzumab deruxtecan | Trastuzumab Deruxtecan in First-line HER2-positive Locally Advanced/MBC Patients Resistant to Trastuzumab+Pertuzumab (TRANSCENDER) | Recruiting | ESP | 0 |
| NCT04014075 | Phase II | Trastuzumab deruxtecan | DS-8201a in HER2-positive Gastric Cancer That Cannot Be Surgically Removed or Has Spread (DESTINY-Gastric02) | Completed | USA | ITA | GBR | ESP | BEL | 0 |
| NCT04752059 | Phase II | Trastuzumab deruxtecan | Phase II Study of T-DX in HER2-positive Breast Cancer Brain Metastases (TUXEDO-1) | Completed | AUT | 0 |
| 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) | Active, not recruiting | USA | ITA | GBR | FRA | ESP | DEU | CAN | AUS | 7 |
| NCT04686305 | Phase I | MEDI5752 + Trastuzumab deruxtecan Trastuzumab deruxtecan Carboplatin + MEDI5752 + Trastuzumab deruxtecan Durvalumab + Pemetrexed Disodium + Trastuzumab deruxtecan Carboplatin + Durvalumab + Trastuzumab deruxtecan Cisplatin + Durvalumab + Trastuzumab deruxtecan | Phase Ib Study of the Safety of T-DXd and Immunotherapy Agents With and Without Chemotherapy in Advanced or Metastatic HER2+, Non-squamous NSCLC (DL03) | Recruiting | USA | NLD | ITA | FRA | ESP | CAN | BEL | AUS | 9 |
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