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 64 HER2 (ERBB2) Antibody-Drug Conjugate 24 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
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
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
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
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
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 | ITA | FRA | ESP | CAN | BEL | AUS 10
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 | FRA | ESP 2
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
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
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 | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 18
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
NCT04752059 Phase II Trastuzumab deruxtecan Phase II Study of T-DX in HER2-positive Breast Cancer Brain Metastases (TUXEDO-1) Completed AUT 0
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
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
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 | ITA | GBR | ESP | DEU | CAN 8
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) Active, not recruiting USA | ITA | GBR | ESP | DEU | CAN | BEL | AUS 10
NCT02564900 Phase I Trastuzumab deruxtecan Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors Active, not recruiting USA 1
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
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 | ITA | FRA | ESP | DEU | CAN | BEL | AUT 12
NCT05965479 Phase II Trastuzumab deruxtecan Developing ctDNA Guided Adjuvant Therapy for Gastrooesophageal Cancer (DECIPHER) Not yet recruiting GBR 0
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) Recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS 22
NCT04616560 Phase II Trastuzumab deruxtecan Trastuzumab Deruxtecan for the Treatment of HER2+ Newly Diagnosed or Recurrent Osteosarcoma Suspended 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
NCT04420598 Phase II Trastuzumab deruxtecan DS-8201a for trEatment of aBc, BRain Mets, And Her2[+] Disease (DEBBRAH) Completed ESP 1
NCT04294628 Phase I Trastuzumab deruxtecan Testing the Biological Effects of DS-8201a on Patients With Advanced Cancer Recruiting USA 0
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 | ITA | FRA | ESP | CAN | AUS 4
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
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
NCT06058988 Phase II Trastuzumab deruxtecan Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer Recruiting USA 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
NCT04482309 Phase II Trastuzumab deruxtecan A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors (DPT02) Active, not recruiting USA | ITA | GBR | ESP | CAN | BEL | AUS 8
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 | ITA | GBR | ESP | BEL 0
NCT05744375 Phase II Trastuzumab deruxtecan Trastuzumab Deruxtecan in First-line HER2-positive Locally Advanced/MBC Patients Resistant to Trastuzumab+Pertuzumab (TRANSCENDER) Recruiting ESP 0
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


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