Therapy Detail
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| Therapy Name | Datopotamab deruxtecan |
| Synonyms | |
| Therapy Description |
Datroway (datopotamab deruxtecan) is an antibody-drug conjugate (ADC) comprising an antibody that targets TROP2 linked to the topoisomerase I inhibitor DXd, which may induce apoptosis and inhibit tumor growth (PMID: 34413126). Datroway (datopotamab deruxtecan) is FDA-approved for use in patients with unresectable or metastatic, hormone receptor-positive, ERBB2 (HER2)-negative breast cancer who have received prior endocrine-based therapy and chemotherapy, in patients with unresectable or metastatic triple-negative breast cancer, and in patients with locally advanced or metastatic EGFR-mutant non-small cell lung cancer who have received prior EGFR-directed therapy and platinum-based chemotherapy (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Datopotamab deruxtecan | Datroway | Dato-DXd|DS1062a|DS 1062a|DS-1062a|datopotamab deruxtecan-dlnk | TROP2 Antibody 20 | Datroway (datopotamab deruxtecan) is an antibody-drug conjugate (ADC) comprising an antibody that targets TROP2 linked to the topoisomerase I inhibitor DXd, which may induce apoptosis and inhibit tumor growth (PMID: 34413126). Datroway (datopotamab deruxtecan) is FDA-approved for use in patients with unresectable or metastatic, hormone receptor-positive, ERBB2 (HER2)-negative breast cancer who have received prior endocrine-based therapy and chemotherapy, in patients with unresectable or metastatic triple-negative breast cancer, and in patients with locally advanced or metastatic EGFR-mutant non-small cell lung cancer who have received prior EGFR-directed therapy and platinum-based chemotherapy (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 |
|---|---|---|---|---|---|---|
| NCT07291037 | Phase III | Datopotamab deruxtecan Docetaxel | Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations (TROPION-Lung17) | Recruiting | USA | TUR | POL | ITA | HUN | GBR | FRA | ESP | DEU | CAN | BRA | BEL | AUT | AUS | 7 |
| NCT05489211 | Phase II | Capecitabine + Datopotamab deruxtecan Datopotamab deruxtecan + MEDI5752 Cisplatin + Datopotamab deruxtecan Carboplatin + Datopotamab deruxtecan Datopotamab deruxtecan + Fluorouracil Datopotamab deruxtecan + Prednisolone Bevacizumab + Datopotamab deruxtecan + Fluorouracil + Leucovorin Datopotamab deruxtecan + Prednisone Bevacizumab + Capecitabine + Datopotamab deruxtecan Bevacizumab + Carboplatin + Datopotamab deruxtecan Datopotamab deruxtecan AZD2936 + Datopotamab deruxtecan | Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) | Recruiting | USA | TUR | POL | ITA | GBR | FRA | ESP | DEU | CHE | CAN | 4 |
| NCT04656652 | Phase III | Docetaxel Datopotamab deruxtecan | Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01) | Active, not recruiting | USA | ROU | POL | NLD | ITA | HUN | GBR | FRA | ESP | DEU | CZE | CHE | CAN | BRA | BEL | AUS | ARG | 9 |
| NCT05374512 | Phase III | Eribulin Nab-paclitaxel Paclitaxel Datopotamab deruxtecan Carboplatin Capecitabine | A Study of Dato-DXd Versus Investigator's Choice Chemotherapy in Patients With Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer, Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy | Active, not recruiting | USA | TUR | POL | ITA | HUN | GBR | FRA | ESP | DEU | CAN | BRA | BEL | ARG | 10 |
| NCT06954480 | Phase II | Datopotamab deruxtecan + Durvalumab Datopotamab deruxtecan | Investigating Datopotamab Deruxtecan Plus Durvalumab Versus Datopotamab Deruxtecan in Patients With PDL1-negative Metastatic Triple-negative Breast Cancer (DIAMOND) | Recruiting | GBR | 0 |
| NCT04940325 | Phase II | Datopotamab deruxtecan | Datopotamab (DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer (ICARUS-LUNG01) | Active, not recruiting | FRA | 0 |
| NCT05866432 | Phase II | Datopotamab deruxtecan | Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases (TUXEDO-2) | Recruiting | AUT | 0 |
| NCT05104866 | Phase III | Gemcitabine Capecitabine Datopotamab deruxtecan Vinorelbine Eribulin | A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01) | Active, not recruiting | USA | POL | NLD | ITA | HUN | GBR | FRA | ESP | DEU | CAN | BRA | BEL | ARG | 7 |
| NCT04484142 | Phase II | Datopotamab deruxtecan | Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations (TROPION-Lung05) | Completed | USA | NLD | ITA | HUN | FRA | ESP | DEU | 3 |
| NCT06533826 | Phase II | Trastuzumab deruxtecan Datopotamab deruxtecan | TReatment of ADC-Refractory Breast CancEr With Dato-DXd or T-DXd: TRADE DXd (TRADE DXd) | Recruiting | USA | 0 |
| NCT05629585 | Phase III | Datopotamab deruxtecan Capecitabine + Pembrolizumab Datopotamab deruxtecan + Durvalumab | A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy | Active, not recruiting | USA | SWE | ITA | GRC | GBR | FRA | ESP | DNK | DEU | CAN | BRA | BEL | 5 |
| NCT06176261 | Phase II | Datopotamab deruxtecan | DATO-BASE: DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs | Recruiting | USA | 0 |
| NCT06130553 | Phase Ib/II | AZD3470 + Datopotamab deruxtecan Datopotamab deruxtecan AZD3470 | A Study of AZD3470, a PRMT5 Inhibitor, Given as Monotherapy and in Combination in Patients With MTAP Deficient Advanced/Metastatic Solid Tumors (PRIMROSE) | Recruiting | USA | NLD | FRA | ESP | AUS | 3 |
| NCT06279728 | Expanded access | Datopotamab deruxtecan | Medical Access Program for Datopotamab Deruxtecan in NSCLC Patients | Approved for marketing | USA | 0 |
| NCT07720284 | Phase III | Durvalumab Datopotamab deruxtecan Nivolumab Enfortumab vedotin-ejfv + Pembrolizumab AZD2936 + Datopotamab deruxtecan | An Open-label Study to Investigate the Efficacy and Safety of Dato-DXd + Rilvegostomig vs SoC in Adult Participants With High-risk MIUC (TU-04) | Recruiting | USA | POL | ITA | GBR | FRA | ESP | DEU | CAN | BRA | AUS | 6 |
| NCT06508216 | Phase Ib/II | Datopotamab deruxtecan + Durvalumab Datopotamab deruxtecan | A Study to Explore Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of Novel Therapeutics in Patients With Early Relapsed Metastatic Triple-negative Breast Cancer (COMPASS-TNBC) | Recruiting | FRA | 0 |
| NCT06103864 | Phase III | Carboplatin + Paclitaxel + Pembrolizumab Carboplatin + Nab-paclitaxel + Pembrolizumab Datopotamab deruxtecan + Durvalumab Datopotamab deruxtecan Carboplatin + Gemcitabine + Pembrolizumab | A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05) | Recruiting | USA | TUR | POL | ITA | GBR | FRA | ESP | DEU | CAN | BRA | AUS | ARG | 12 |
| NCT03401385 | Phase I | Datopotamab deruxtecan | First-in-human Study of DS-1062a for Advanced Solid Tumors | Active, not recruiting | USA | 1 |
| NCT07069595 | Phase II | Datopotamab deruxtecan | PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease (PREDICT-RD) | Recruiting | USA | 0 |
| NCT07205822 | Phase III | Datopotamab deruxtecan | A Study of Dato-DXd in Inoperable or Metastatic Hormone Receptor-positive, HER2 IHC 0 Breast Cancer (TB06) | Recruiting | USA | ITA | FRA | ESP | 2 |
| NCT06417814 | Phase III | Cisplatin + Pemetrexed Disodium Carboplatin + Pemetrexed Disodium Datopotamab deruxtecan + Osimertinib Datopotamab deruxtecan | A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (TROPION-Lung15) | Active, not recruiting | USA | POL | ITA | ISR | GRC | GBR | FRA | ESP | DEU | CAN | BRA | BEL | AUS | 11 |
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