Drugs / Datopotamab deruxtecan
Datopotamab deruxtecan
also known as
Dato-DXd · Datopotamab deruxtecan (Dato-DXd, DS-1062a) · DS-1062a · ADC DS-1062A · Datopotamab deruxtecan-dlnk · DS-1026a · DS-1062
Monoclonal antibody targets TACSTD2, TOP1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed lung cancer 1 milestone | |||||
| Filed | US (FDA) | — | lung cancer | 2024-11-12 | “AstraZeneca and Daiichi Sankyo have submitted a new Biologics License Application (BLA) for accelerated approval in the US for datopotamab deruxtecan” astrazeneca.com ↗ |
| Filed non-small cell lung carcinoma 1 milestone | |||||
| Filed | US (FDA) | — | non-small cell lung carcinoma | 2024-02-19 | “Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in the US” astrazeneca.com ↗ |
| Filed triple-negative breast carcinoma 1 milestone | |||||
| Filed | US (FDA) | Datroway | triple-negative breast carcinoma | 2026-02-03 | “AstraZeneca and Daiichi Sankyo’s supplemental Biologics License Application (sBLA) for Datroway (datopotamab deruxtecan) has been accepted and granted Priority Review in the US” astrazeneca.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansion | US (FDA) | DATROWAY | — | 2026-05-22 | fda.gov ↗ |
| Approved | EU (EMA) | Datroway | — | 2025-04-04 | europa.eu ↗ |
| Approved | US (FDA) | DATROWAY | — | 2025-01-17 | fda.gov ↗ |
Trials 45
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT06244485 | Feb 2024 → Nov 2028 expected | neoplasm | Daiichi Sankyo | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05117476 | Oct 2021 → Mar 2026 overdue | non-small cell lung carcinoma | Cullinan Therapeutics Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04612751 | Feb 2021 → May 2026 overdue | non-small cell lung carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04526691 | Sep 2020 → Apr 2024 overdue | non-small cell lung carcinoma | Daiichi Sankyo | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03401385 | Jan 2018 → Jan 2028 expected | hormone receptor-positive breast cancer, non-small cell lung carcinoma, triple-negative breast carcinoma | Daiichi Sankyo | Active not recruiting | No outcome recorded |
| Phase 1/27 trials · 1 missed | ||||||
| Phase 1/2 | NCT07535437 | Apr 2026 → Apr 2028 expected | non-small cell lung carcinoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06508216 | Jul 2024 → Dec 2025 overdue | breast cancer | Gustave Roussy, Cancer Campus, Grand Paris | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06130553 | Jan 2024 → Dec 2028 expected | — | AstraZeneca | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05460273 | Jul 2022 → Nov 2023 overdue | non-small cell lung carcinoma, triple-negative breast carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05417594 | Jun 2022 → Feb 2028 expected | high grade malignant neoplasm | AstraZeneca | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04644068 | Nov 2020 → May 2027 expected | biliary tract cancer, breast cancer, cervical cancer, colorectal cancer +8 | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03742102 | Dec 2018 → Nov 2024 overdue | triple-negative breast carcinoma | AstraZeneca | Active not recruiting | Missed primary |
| Phase 216 trials | ||||||
| Phase 2 | NCT07825753 | Sep 2026 → Sep 2027 expected | breast cancer, pancreatic adenocarcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07471776 | Mar 2026 → Mar 2028 expected | Her2-receptor negative breast cancer | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT07069595 | Feb 2026 → Nov 2031 expected | triple-negative breast carcinoma | UNC Lineberger Comprehensive Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06954480 | Oct 2025 → Feb 2028 expected | triple-negative breast carcinoma | Queen Mary University of London | Recruiting | No outcome recorded |
| Phase 2 | NCT06822543 | Sep 2025 → Jun 2028 expected | metastatic malignant neoplasm in the brain, non-small cell lung carcinoma | Latin American Cooperative Oncology Group | Recruiting | No outcome recorded |
| Phase 2 | NCT07098338 | Aug 2025 → Apr 2029 expected | non-small cell lung carcinoma | AstraZeneca | Recruiting | No outcome recorded |
| Phase 2 | NCT06676917 | Jun 2025 → Aug 2027 | non-small cell lung carcinoma | MedSIR | Withdrawn | No outcome recorded |
| Phase 2 | NCT06533826 | Oct 2024 → Jan 2028 expected | Her2-receptor negative breast cancer | Ana C Garrido-Castro, MD | Recruiting | No outcome recorded |
| Phase 2 | NCT06176261 | Jan 2024 → Jan 2028 expected | estrogen-receptor positive breast cancer, female breast carcinoma, triple-negative breast carcinoma | Sarah Sammons, MD | Recruiting | No outcome recorded |
| Phase 2 | NCT05866432 | Jul 2023 → May 2026 overdue | breast cancer | Medical University of Vienna | Recruiting | No outcome recorded |
| Phase 2 | NCT05489211 | Sep 2022 → Oct 2027 expected | biliary tract cancer, castration-resistant prostate carcinoma, colorectal cancer, endometrial cancer +3 | AstraZeneca | Recruiting | No outcome recorded |
| Phase 2 | NCT05061550 | Apr 2022 → May 2030 expected | non-small cell lung carcinoma | AstraZeneca | Recruiting | No outcome recorded |
| Phase 2 | NCT04940325 | May 2021 → Apr 2028 expected | non-small cell lung carcinoma | Gustave Roussy, Cancer Campus, Grand Paris | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04484142 | Mar 2021 → Mar 2023 | non-small cell lung carcinoma | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 2 | NCT03944772 | Jun 2019 → May 2025 overdue | non-small cell lung carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 2 | NCT01042379 | Mar 2010 → Dec 2030 expected | HER2 positive breast carcinoma, angiosarcoma, female breast carcinoma, hormone receptor-positive breast cancer +1 | QuantumLeap Healthcare Collaborative | Recruiting | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT07129993 | Sep 2025 → Jun 2029 expected | urinary bladder cancer, urothelial carcinoma | Daiichi Sankyo | Recruiting | No outcome recorded |
| Phase 315 trials · 1 met primary | ||||||
| Phase 3 | NCT07291037 | Oct 2025 → Jan 2029 expected | non-small cell lung carcinoma | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT07205822 | Oct 2025 → Feb 2028 expected | breast cancer | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT06564844 | Oct 2024 → Jul 2026 overdue | non-small cell lung carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06417814 | Oct 2024 → Sep 2026 overdue | non-small cell lung carcinoma | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT06350097 | Apr 2024 → Mar 2028 expected | non-small cell lung carcinoma | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT06357533 | Apr 2024 → Dec 2029 expected | non-small cell lung carcinoma | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT06103864 | Nov 2023 → Jul 2027 expected | breast cancer | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT06112379 | Nov 2023 → Nov 2028 expected | breast cancer | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05555732 | Jan 2023 → May 2029 expected | non-small cell lung carcinoma | Daiichi Sankyo | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05687266 | Dec 2022 → Nov 2027 expected | non-small cell lung carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05629585 | Nov 2022 → Sep 2027 expected | breast cancer | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05374512 | May 2022 → Aug 2025 overdue | breast cancer | AstraZeneca | Active not recruiting | Met primary |
| Phase 3 | NCT05215340 | Mar 2022 → Mar 2030 expected | non-small cell lung carcinoma | Daiichi Sankyo | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05104866 | Oct 2021 → Jul 2024 overdue | breast cancer | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04656652 | Dec 2020 → May 2024 overdue | non-small cell lung carcinoma | Daiichi Sankyo | Active not recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT06279728 | — | lung cancer | Daiichi Sankyo | Approved for marketing | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 2 | NCT07474558 Background | Sep 2026 → Jan 2030 expected | alopecia, metastatic neoplasm | Jules Bordet Institute | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06974604 Background | Oct 2025 → May 2027 expected | breast neoplasm, lung neoplasm | Brown University | Recruiting | No outcome recorded |
| Phase 4 | NCT07357597 Background | Jun 2026 → Jan 2028 expected | stomatitis | AstraZeneca | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 35
| Date | Issuer | Release |
|---|---|---|
| 2026-07-31 | AstraZeneca | Regulatory Datroway approved in the EU as only TROP2-directed medicine with overall survival benefit for the 1st-line treatment of patients with metastatic TNBC who are not candidates for immunotherapy astrazeneca.com ↗
AstraZeneca and Daiichi Sankyo’s Datroway (datopotamab deruxtecan) has been approved in the European Union (EU) as monotherapy for the 1st-line treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. |
| 2026-06-26 | AstraZeneca | Regulatory Datroway recommended for approval in the EU by CHMP as 1st-line treatment for patients with metastatic triple-negative breast cancer who are not candidates for immunotherapy astrazeneca.com ↗ |
| 2026-06-01 | Daiichi Sankyo | Regulatory Anvisa aprova datopotamabe deruxtecana para pacientes com câncer de mama metastático RH positivo, HER2 negativo que receberam terapia endócrina prévia e pelo menos uma linha de quimioterapia daiichisankyo.com.br ↗
A Agência Nacional de Vigilância Sanitária (Anvisa) anunciou a aprovação do datopotamabe deruxtecana (Dato-Dxd) no Brasil para o tratamento de pacientes adultos com câncer de mama irressecável ou metastático receptor hormonal (RH) positivo, HER2 negativo (IHC 0, IHC 1+ ou IHC 2+/ISH-), que receberam terapia endócrina prévia e pelo menos uma linha de quimioterapia. |
| 2026-05-22 | AstraZeneca | Regulatory Datroway approved in the US as first TROP2-directed antibody drug conjugate for 1st-line treatment of patients with metastatic triple-negative breast cancer who are not PD-1/PD-L1 inhibitor candidates astrazeneca.com ↗
AstraZeneca and Daiichi Sankyo’s Datroway (datopotamab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. |
| 2026-02-03 | AstraZeneca | Regulatory Datroway granted Priority Review in the US as 1st-line treatment for patients with metastatic triple-negative breast cancer who are not candidates for immunotherapy astrazeneca.com ↗ |
| 2025-10-19 | AstraZeneca | Results Datroway demonstrated an unprecedented median overall survival improvement of five months vs. chemotherapy as 1st-line treatment for patients with metastatic triple-negative breast cancer for whom immunotherapy was not an option in TROPION-Breast02 astrazeneca.com ↗
Datroway demonstrated a 5.0-month improvement in median OS compared to chemotherapy (hazard ratio [HR] 0.79; 95% confidence interval [CI] 0.64-0.98; p=0.0291). |
| 2025-10-06 | AstraZeneca | Results Datroway demonstrated statistically significant and clinically meaningful improvement in overall survival as 1st-line therapy for patients with metastatic triple-negative breast cancer for whom immunotherapy was not an option in TROPION-Breast02 astrazeneca.com ↗
AstraZeneca and Daiichi Sankyo’s Datroway is the first and only therapy to significantly improve overall survival vs. chemotherapy in this patient population |
| 2025-06-23 | AstraZeneca | Regulatory Datroway approved in the US for patients with previously treated advanced EGFR-mutated non-small cell lung cancer astrazeneca.com ↗
Datroway (datopotamab deruxtecan or Dato-DXd) has been approved in the US for the treatment of adult patients with locally advanced or metastatic EGFR -mutated non-small cell lung cancer (NSCLC) who have received prior EGFR -directed therapy and platinum-based chemotherapy. |
| 2025-03-25 | AstraZeneca | Results New study results reinforce Tagrisso as the backbone therapy for EGFR-mutated lung cancer across stages and settings astrazeneca.com ↗
SAVANNAH and ORCHARD Phase II trials show the addition of Orpathys or Datroway to Tagrisso upon disease progression demonstrates strong clinical activity |
| 2025-01-17 | AstraZeneca | Regulatory Datroway (datopotamab deruxtecan) approved in the US for patients with previously treated metastatic HR-positive, HER2-negative breast cancer astrazeneca.com ↗
The approval by the US Food and Drug Administration (FDA) was based on results from the TROPION-Breast01 Phase III trial. |
| 2025-01-13 | AstraZeneca | Regulatory Datopotamab deruxtecan granted Priority Review in the US for patients with previously treated advanced EGFR-mutated non-small cell lung cancer astrazeneca.com ↗ |
| 2025-01-13 | ChemRar Research and Development Institute, LLC | Regulatory Дайджест FDA (статусы Breakthrough therapy designation) — декабрь 2024 года chemrar.ru ↗
FDA предоставило Daiichi Sankyo статус прорывной терапии для ее конъюгата антитела с лекарственным средством (ADC) датопотамаба дерукстекана (datopotamab deruxtecan), который предназначен для лечения немелкоклеточного рака легких (НМРЛ). |
| 2024-12-24 | AstraZeneca | Regulatory Datopotamab deruxtecan application in the EU for patients with advanced nonsquamous non-small cell lung cancer voluntarily withdrawn astrazeneca.com ↗
The decision to withdraw the MAA was informed by feedback from the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA). |
| 2024-12-09 | AstraZeneca | Regulatory Datopotamab deruxtecan granted breakthrough therapy designation in US for patients with previously treated advanced EGFR-mutated non-small cell lung cancer astrazeneca.com ↗
The FDA granted this BTD based on data from the TROPION-Lung05 Phase II trial with supporting data from the TROPION-Lung01 Phase III trial. |
| 2024-11-12 | AstraZeneca | Regulatory Datopotamab deruxtecan new BLA submitted for accelerated approval in the US for patients with previously treated advanced EGFR-mutated non-small cell lung cancer astrazeneca.com ↗
AstraZeneca and Daiichi Sankyo have submitted a new Biologics License Application (BLA) for accelerated approval in the US for datopotamab deruxtecan (Dato-DXd) for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated ( EGFR ) non-small cell lung cancer (NSCLC) who have received prior systemic therapies, including an EGFR -directed therapy. |
| 2024-09-23 | AstraZeneca | Results Datopotamab deruxtecan final overall survival results reported in patients with metastatic HR-positive, HER2-low or negative breast cancer in TROPION-Breast01 Phase III trial astrazeneca.com ↗
Survival results for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan in TROPION-Breast01 did not achieve statistical significance versus chemotherapy |
| 2024-09-09 | AstraZeneca | Results Datopotamab deruxtecan showed median overall survival of 14.6 months in patients with advanced nonsquamous non-small cell lung cancer in TROPION-Lung01 Phase III trial astrazeneca.com ↗
In the prespecified subgroup of patients with nonsquamous NSCLC, datopotamab deruxtecan showed a 2.3-month improvement in OS compared to docetaxel (14.6 versus 12.3 months; HR 0.84; 95% CI 0.68-1.05). |
| 2024-09-08 | AstraZeneca | Results Novel computational pathology-based TROP2 biomarker for datopotamab deruxtecan was predictive of clinical outcomes in patients with non-small cell lung cancer in TROPION-Lung01 Phase III trial astrazeneca.com ↗
In patients with TROP2-QCS biomarker positive tumours, datopotamab deruxtecan demonstrated a meaningfully greater magnitude of efficacy versus docetaxel than in the overall trial population. |
| 2024-09-03 | AstraZeneca | Results AstraZeneca advances ambition to improve standards of care in multiple cancer types at WCLC and ESMO 2024 astrazeneca.com ↗
Normalized membrane ratio of TROP2 by quantitative continuous scoring is predictive of clinical outcomes in TROPION-Lung 01 |
| 2024-05-27 | AstraZeneca | Results Datopotamab deruxtecan showed clinically meaningful overall survival improvement vs. chemotherapy in patients with advanced nonsquamous non-small cell lung cancer in TROPION-Lung01 Phase III trial astrazeneca.com ↗
In the prespecified subgroup of patients with nonsquamous NSCLC, datopotamab deruxtecan showed a clinically meaningful improvement in OS compared to docetaxel, the current standard-of-care chemotherapy. |
| 2024-04-02 | AstraZeneca | Regulatory Datopotamab deruxtecan Biologics License Application accepted in the US for patients with previously treated metastatic HR-positive, HER2-negative breast cancer astrazeneca.com ↗
AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in the US for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior systemic therapy for unresectable or metastatic disease. |
| 2024-03-04 | AstraZeneca | Regulatory Two datopotamab deruxtecan applications validated in the EU for patients with advanced nonsquamous non-small cell lung cancer or HR-positive, HER2-negative breast cancer astrazeneca.com ↗
The European Medicines Agency (EMA) has validated two marketing authorisation applications (MAAs) for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan (Dato-DXd) in two types of cancer. |
| 2024-02-19 | AstraZeneca | Regulatory Datopotamab deruxtecan Biologics License Application accepted in the US for patients with previously treated advanced nonsquamous non-small cell lung cancer astrazeneca.com ↗ |
| 2023-10-23 | AstraZeneca | Results Datopotamab deruxtecan significantly extended progression-free survival vs. chemotherapy in patients with HR-positive, HER2-low or negative breast cancer in TROPION-Breast01 Phase III trial astrazeneca.com ↗
Median PFS was 6.9 months in patients treated with datopotamab deruxtecan versus 4.9 with chemotherapy. |
| 2023-10-23 | AstraZeneca | Results Datopotamab deruxtecan improved progression-free survival vs. chemotherapy in patients with previously treated non-small cell lung cancer in TROPION-Lung01 Phase III trial astrazeneca.com ↗
Datopotamab deruxtecan reduced the risk of disease progression or death by 25% compared to docetaxel (hazard ratio [HR] 0.75; 95% confidence interval [CI] 0.62-0.91; p=0.004) as assessed by blinded independent central review (BICR). |
| 2023-10-22 | AstraZeneca | Results Datopotamab deruxtecan plus Imfinzi demonstrated robust and durable tumour responses in 1st-line treatment of patients with metastatic triple-negative breast cancer in BEGONIA Phase Ib/II trial astrazeneca.com ↗
Results showed that datopotamab deruxtecan plus Imfinzi, an anti-PD-L1 therapy, demonstrated a confirmed objective response rate (ORR) of 79% (n=49 of 62) including six complete responses (CRs) and 43 partial responses (PRs). |
| 2023-09-22 | AstraZeneca | Results Datopotamab deruxtecan demonstrated statistically significant and clinically meaningful progression-free survival benefit in patients with HR-positive, HER2-low or negative breast cancer in TROPION-Breast01 Phase III trial astrazeneca.com ↗
A trend in improvement for the dual primary endpoint of overall survival (OS) was observed for datopotamab deruxtecan versus chemotherapy. |
| 2023-09-10 | AstraZeneca | Results Datopotamab deruxtecan plus Imfinzi showed promising clinical activity in the first-line advanced non-small cell lung cancer setting in TROPION-Lung04 Phase Ib trial astrazeneca.com ↗
AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan plus Imfinzi with or without chemotherapy demonstrated objective response rates of 77% and 50% and disease control rates of 92% and 93%, respectively |
| 2023-07-03 | AstraZeneca | Results Datopotamab deruxtecan met dual primary endpoint of progression-free survival in patients with advanced non-small cell lung cancer in TROPION-Lung01 Phase III trial astrazeneca.com ↗
First Phase III results for AstraZeneca and Daiichi Sankyo’s TROP2-directed antibody drug conjugate demonstrated statistically significant improvement in progression-free survival vs. standard chemotherapy in previously treated locally advanced or metastatic disease |
| 2023-06-05 | AstraZeneca | Results Datopotamab deruxtecan combinations showed encouraging tumour responses in patients with advanced non-small cell lung cancer in TROPION-Lung02 Phase Ib trial astrazeneca.com ↗
In previously untreated patients, AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan plus pembrolizumab with or without platinum chemotherapy demonstrated objective response rates of 57% and 50%, respectively, with a disease control rate of 91% across cohorts |
| 2022-12-09 | AstraZeneca | Results Datopotamab deruxtecan showed promising responses as monotherapy and in combination with Imfinzi in patients with metastatic triple-negative breast cancer in two early trials astrazeneca.com ↗
Updated results from the TROPION-PanTumor01 Phase I trial showed datopotamab deruxtecan (Dato-DXd) continued to demonstrate encouraging responses in patients with heavily pretreated metastatic triple-negative breast cancer (TNBC) and disease progression following standard treatment. |
| 2022-12-08 | AstraZeneca | Results Datopotamab deruxtecan showed encouraging and durable efficacy in patients with heavily pretreated HR-positive, HER2-low or negative metastatic breast cancer astrazeneca.com ↗
In this cohort of TROPION-PanTumor01 (n=41), datopotamab deruxtecan demonstrated an objective response rate (ORR) of 27% as assessed by blinded independent central review (BICR). |
| 2022-08-09 | AstraZeneca | Results Datopotamab deruxtecan-based combinations show promising clinical activity in patients with advanced non-small cell lung cancer astrazeneca.com ↗
Results were presented during a late-breaking presentation (#MA13.07) today at the International Association for the Study of Lung Cancer 2022 World Conference on Lung Cancer (WCLC). |
| 2021-01-29 | Daiichi Sankyo | Results Datopotamab Deruxtecan and ENHERTU® Show Promising Early Clinical Activity in Patients with Advanced Non-Small Cell Lung Cancer daiichisankyo.com ↗
Updated results from the TROPION-PanTumor01 phase 1 trial showed promising clinical activity for datopotamab deruxtecan, a TROP2 directed DXd ADC, in patients with advanced or metastatic NSCLC. |
| 2021-01-29 | AstraZeneca | Results Datopotamab deruxtecan and Enhertu show promising early clinical activity in patients with advanced non-small cell lung cancer astrazeneca.com ↗
Updated results from the TROPION-PanTumor01 Phase I trial showed promising clinical activity for datopotamab deruxtecan, a TROP2-directed ADC, in patients with advanced or metastatic NSCLC. |
All press releases naming this drug 44 releases
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 53 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Datopotamab-Deruxtecan | “Datopotamab deruxtecan (Dato-DXd), an antibody-drug conjugate comprising a humanized anti-trophoblast cell-surface antigen 2 (TROP 2) monoclonal antibody conjugated to a potent...” PMID 41466843 ↗ Dec 202536“Datopotamab deruxtecan (Dato-DXd) consists of a TROP2-directed humanized IgG1 monoclonal antibody attached via a serum-stable cleavable linker to a topoisomerase I inhibitor payload.” PMID 37387213 ↗ Jun 2023 “Phase II Study of Datopotamab-Deruxtecan (Dato-DXd; DS-1026a) in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases” NCT05866432 ↗ “Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer” NCT04940325 ↗ “Patients in module 1 \& 2 will receive Datopotamab Deruxtecan (Dato-DXd) 6mg/kg every 21 days” NCT06508216 ↗ “Participants will receive datopotamab deruxtecan (Dato-DXd) via intravenous route.” NCT05061550 ↗ “Datopotamab Deruxtecan (Dato-DXd DS-1062a)” NCT06974604 ↗ “datopotamab deruxtecan- (Dato-DXd)” NCT07535437 ↗ |
| Known as | ADC DS-1062A | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297939 ↗ |
| Known as | Dato-DXd | “Datopotamab deruxtecan (Dato-DXd) is an antibody-drug conjugate consisting of a humanized antitrophoblast cell-surface antigen 2 (TROP2) monoclonal antibody linked to a potent,...” PMID 38652877 ↗ Apr 202426“Datopotamab deruxtecan (Dato-DXd) is an antibody-drug conjugate (ADC) consisting of a humanized anti-TROP2 IgG1 monoclonal antibody covalently linked to the topoisomerase I...” NCT07825753 ↗ “This study will assess safety and treatment activity of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab with or without platinum chemotherapy in...” NCT04526691 ↗ “Datopotamab deruxtecan (Dato-DXd), an antibody-drug conjugate comprising a humanized anti-trophoblast cell-surface antigen 2 (TROP 2) monoclonal antibody conjugated to a potent...” PMID 41466843 ↗ Dec 2025 “Datopotamab deruxtecan (Dato-DXd) is a novel antibody-drug conjugate (ADC) composed of a humanized anti-TROP2 IgG1 monoclonal antibody linked to a topoisomerase I inhibitor...” NCT06822543 ↗ “Phase II Study of Datopotamab-Deruxtecan (Dato-DXd; DS-1026a) in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases” NCT05866432 ↗ “Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer” NCT04940325 ↗ “Datopotamab Deruxtecan (Dato-DXd DS-1062a)” NCT06974604 ↗ “Drug: Datopotamab Deruxtecan (Dato-DXd)” NCT07357597 ↗ “Datopotamab deruxtecan-dlnk (Dato-DXd)” NCT05117476 ↗ “Dato-DXd, 6 mg/kg Q3W, IV for 12 weeks” NCT01042379 ↗ |
| Known as | Datopotamab deruxtecan (Dato-DXd, DS-1062a) | “Datopotamab deruxtecan (Dato-DXd, DS-1062a)” NCT06103864 ↗4“Datopotamab deruxtecan (Dato-DXd, DS-1062a)” NCT05104866 ↗ “Datopotamab deruxtecan (Dato-DXd, DS-1062a)” NCT06112379 ↗ “Datopotamab deruxtecan (Dato-DXd, DS-1062a)” NCT05629585 ↗ “Datopotamab deruxtecan (Dato-DXd, DS-1062a)” NCT05374512 ↗ |
| Known as | Datopotamab deruxtecan-dlnk | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05117476 ↗ |
| Known as | DS-1026a | “Phase II Study of Datopotamab-Deruxtecan (Dato-DXd; DS-1026a) in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases” NCT05866432 ↗ |
| Known as | DS-1062 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297939 ↗ |
| Known as | DS-1062a | “Datopotamab deruxtecan (DS-1062a) 6.0 mg/kg body weight i.v. on day 1 once every three weeks” NCT05866432 ↗ |
| Action | Deplete | “Datopotamab binds to TROP2, a protein found on breast cancer cells, and is taken into the tumor cell where the linker breaks, releasing DXd to kill the cell.” PMID 38686016 ↗ Apr 2024 |
| Action | Inhibit | “DNA topoisomerase I inhibitor” CHEMBL4297939 ↗ |
| Modality | Other / unclassified | “is a trophoblast cell-surface antigen-2-directed antibody-drug conjugate with a highly potent topoisomerase I inhibitor payload” PMID 39761483 ↗ Jan 2025 |
| Route | Intravenous | “Datopotamab deruxtecan iv 3-week cycles (once weekly) q3w” NCT03742102 ↗ |
| Target | TACSTD2 | “humanized anti-TROP2 IgG1 monoclonal antibody” NCT07825753 ↗ |
| Target | TOP1 | “DNA topoisomerase I inhibitor” CHEMBL4297939 ↗ |