Therapy Detail
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| Therapy Name | Datopotamab deruxtecan + Durvalumab |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Datopotamab deruxtecan | Dato-DXd|DS1062a|DS 1062a|DS-1062a | TROP2 Antibody 13 | Datopotamab deruxtecan (DS-1062a) 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). | |
| Durvalumab | Imfinzi | MEDI4736 | Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 121 | Imfinzi (durvalumab) is a monoclonal antibody that binds to and inhibits PD-L1 (CD274), potentially resulting in increased immune response to tumors (PMID: 25943534, PMID: 28214651). Imfinzi (durvalumab) is FDA-approved for use in patients with urothelial carcinoma and unresectable, stage III non-small cell lung cancer, in combination with Imjudo (tremelimumab) and platinum-based chemotherapy in patients with metastatic non-small cell lung cancer (NSCLC) without sensitizing EGFR or ALK mutations, in combination with platinum-based chemotherapy as neoadjuvant therapy followed by surgery and adjuvant Imfinzi (durvalumab) in patients with resectable non-small cell lung cancer, in combination with etoposide and carboplatin or cisplatin in patients with extensive stage small cell lung cancer, in combination with cisplatin and gemcitabine in patients with locally advanced or metastatic biliary tract cancer, in combination with Imjudo (tremelimumab) in adult patients with unresectable hepatocellular carcinoma, and in combination with carboplatin plus paclitaxel followed by single-agent Imfinzi (durvalumab) in adult patients with mismatch repair deficient endometrial cancer (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 |
|---|---|---|---|---|---|---|
| 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 | Recruiting | USA | TUR | POL | ITA | GBR | FRA | ESP | DEU | CAN | BRA | AUS | ARG | 11 |
| NCT06112379 | Phase III | Carboplatin + Paclitaxel Cyclophosphamide + Epirubicin + Paclitaxel Capecitabine Carboplatin + Cyclophosphamide + Doxorubicin + Paclitaxel Cyclophosphamide + Doxorubicin + Pembrolizumab Cyclophosphamide + Epirubicin + Pembrolizumab Datopotamab deruxtecan + Durvalumab Cyclophosphamide + Doxorubicin + Paclitaxel Carboplatin + Paclitaxel + Pembrolizumab | A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer | Recruiting | USA | TUR | POL | ITA | HUN | GBR | FRA | ESP | DEU | CHE | CAN | BRA | BGR | BEL | AUT | AUS | 10 |
| NCT04612751 | Phase I | Datopotamab deruxtecan + Durvalumab AZD2936 + Carboplatin + Datopotamab deruxtecan AZD2936 + Datopotamab deruxtecan Carboplatin + Datopotamab deruxtecan + Durvalumab Datopotamab deruxtecan + MEDI5752 Carboplatin + Datopotamab deruxtecan + MEDI5752 | Phase 1b Study of Dato-DXd in Combination With Immunotherapy With or Without Carboplatin in Advanced or Metastatic Non-Small Cell Lung Cancer (TROPION-Lung04) | Recruiting | USA | TUR | POL | ITA | FRA | ESP | BEL | 3 |
| NCT05489211 | Phase II | Capecitabine + Datopotamab deruxtecan Datopotamab deruxtecan + Durvalumab + Saruparib Capecitabine + Datopotamab deruxtecan + Nivolumab Carboplatin + Datopotamab deruxtecan Datopotamab deruxtecan + Fluorouracil Datopotamab deruxtecan + Saruparib Datopotamab deruxtecan + Durvalumab Datopotamab deruxtecan + Fluorouracil + Nivolumab Bevacizumab + Datopotamab deruxtecan + Fluorouracil + Leucovorin Bevacizumab + Capecitabine + Datopotamab deruxtecan Datopotamab deruxtecan | Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours | Recruiting | USA | TUR | POL | ITA | GBR | FRA | ESP | DEU | CHE | CAN | 4 |
| 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 |
| 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 | Recruiting | USA | SWE | ITA | GRC | GBR | FRA | ESP | DNK | DEU | CAN | BRA | BEL | 5 |
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