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DRUG:

Datroway (datopotamab deruxtecan-dlnk)

i
Other names: DS-1062a, DS-1062, DS 1062, Dato-DXd, Dato DXd, DS 1062a, DS1062a, DS1062, DatoDXd
Company:
AstraZeneca, Daiichi Sankyo
Drug class:
Topoisomerase I inhibitor, TROP-2-targeted antibody-drug conjugate
Related drugs:
8d
Therapeutic Applications and Target Strategies of Antibody-Drug Conjugates in Ovarian Cancer. (PubMed, Iran J Pharm Res)
This review summarizes a range of ADCs targeting tumor-associated antigens in ovarian cancer, including mirvetuximab soravtansine (MIRV), trastuzumab deruxtecan (T-DXd), datopotamab deruxtecan (Dato-DXd), sacituzumab tirumotecan (SKB-264), PF-06664178, anetumab ravtansine (BAY 94-9343), BMS-986148, DMOT4039A, RC88, lifastuzumab vedotin (DNIB0600A), upifitamab rilsodotin (ABBV-181), ZW220, DMUC4064A, and sofituzumab vedotin (DMUC5754A). The ADCs hold significant potential to reshape the treatment landscape for ovarian cancer by providing targeted therapeutic options. Further research is required to optimize patient selection, address resistance mechanisms, and improve safety profiles.
Review • Journal
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MUC4 (Mucin 4, Cell Surface Associated)
|
Enhertu (fam-trastuzumab deruxtecan-nxki) • Elahere (mirvetuximab soravtansine-gynx) • budigalimab (ABBV-181) • Datroway (datopotamab deruxtecan-dlnk) • Jiataile (sacituzumab tirumotecan) • anetumab ravtansine (BAY 94-9343) • upifitamab rilsodotin (XMT-1536) • RG7600 • lifastuzumab vedotin (DNIB0600A) • RG7882 • ZW220 • BMS-986148
9d
TROPION Lung15: 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 (clinicaltrials.gov)
P3, N=744, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting | Trial completion date: May 2028 --> Sep 2028 | Trial primary completion date: Jun 2026 --> Sep 2026
Enrollment closed • Trial completion date • Trial primary completion date
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cisplatin • Tagrisso (osimertinib) • carboplatin • pemetrexed • Datroway (datopotamab deruxtecan-dlnk)
12d
Targeting TROP2 Across Solid Tumors: The Clinical Profile and Role of Datopotamab Deruxtecan. (PubMed, Ann Pharmacother)
Dato-DXd offers a promising treatment option for heavily pretreated patients with HR+/HER2- breast cancer and EGFR-mutant NSCLC, providing meaningful clinical benefit with a manageable safety profile. Optimal sequencing and positioning within the rapidly shifting ADC landscape requires further investigation.
Review • Journal
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EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
|
EGFR mutation • HR positive • HER-2 negative • HR positive + HER-2 negative
|
docetaxel • Datroway (datopotamab deruxtecan-dlnk)
16d
ICARUS-LUNG01: Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer (clinicaltrials.gov)
P2, N=100, Active, not recruiting, Gustave Roussy, Cancer Campus, Grand Paris | Trial primary completion date: Sep 2025 --> Apr 2028
Trial primary completion date
|
EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
|
EGFR mutation • BRAF mutation • RET mutation • MET mutation • NTRK fusion
|
Datroway (datopotamab deruxtecan-dlnk)
16d
Enrollment open
|
Datroway (datopotamab deruxtecan-dlnk)
18d
CERTIS1: Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies (clinicaltrials.gov)
P1/2, N=695, Recruiting, AstraZeneca | Trial completion date: Apr 2027 --> Aug 2027 | Trial primary completion date: Apr 2027 --> Aug 2027
Trial completion date • Trial primary completion date
|
HER-2 (Human epidermal growth factor receptor 2) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • HRD (Homologous Recombination Deficiency) • RAD51C (RAD51 paralog C) • RAD51D (RAD51 paralog D)
|
HER-2 negative • PALB2 mutation • RAD51C mutation • RAD51D mutation
|
temozolomide • Enhertu (fam-trastuzumab deruxtecan-nxki) • Datroway (datopotamab deruxtecan-dlnk) • AZD9574
18d
CLN-619-001: A Study of CLN-619 Alone and in Combination With Pembrolizumab in Advanced Solid Tumors (clinicaltrials.gov)
P1, N=440, Active, not recruiting, Cullinan Therapeutics Inc. | Recruiting --> Active, not recruiting
Enrollment closed
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
Keytruda (pembrolizumab) • carboplatin • paclitaxel • pemetrexed • Datroway (datopotamab deruxtecan-dlnk) • CLN-619
23d
Enrollment open
|
PD-L1 IHC 22C3 pharmDx
|
Imfinzi (durvalumab) • Datroway (datopotamab deruxtecan-dlnk)
23d
Inhibiting TROP2 in advanced non-small-cell lung cancer with sacituzumab govitecan, datopotamab deruxtecan, and sacituzumab tirumotecan: similarities and differences. (PubMed, Cancer Chemother Pharmacol)
There are differences in pharmacological effects, efficacy, and incidence of adverse events among sacituzumab govitecan, datopotamab deruxtecan, and sacituzumab tirumotecan. For patients with EGFR-mutated progression after targeted therapy or driver gene negative advanced non-small cell lung cancer, the individualized optimization of TROP2 ADCs treatment can obtain the greatest benefit.
Review • Journal • IO biomarker
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation
|
Trodelvy (sacituzumab govitecan-hziy) • Datroway (datopotamab deruxtecan-dlnk) • Jiataile (sacituzumab tirumotecan)
1m
Trial primary completion date
|
HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
|
PD-L1 expression • PD-L1 negative
|
carboplatin • capecitabine • albumin-bound paclitaxel • Halaven (eribulin mesylate) • Datroway (datopotamab deruxtecan-dlnk)
1m
Datopotamab deruxtecan: a new era in targeted therapy for metastatic breast cancer. (PubMed, Ann Med Surg (Lond))
With better efficacy than conventional treatments, it offers a possible alternative for individuals who have not responded to previous endocrine or chemotherapy therapies. This manuscript reviews the mechanisms of action, clinical efficacy, safety profiles, and trials of Dato-DXd and T-DXd, highlighting their transformative potential and positioning in current breast cancer treatment algorithms.
Journal
|
HER-2 (Human epidermal growth factor receptor 2)
|
HR positive • HER-2 negative • EGFR positive
|
Enhertu (fam-trastuzumab deruxtecan-nxki) • Datroway (datopotamab deruxtecan-dlnk)
2ms
Preventing Dato-DXd Associated Stomatitis With Dexamethasone Mouthwash, TROPION-DM (clinicaltrials.gov)
P2, N=60, Recruiting, Brown University | Not yet recruiting --> Recruiting
Enrollment open
|
dexamethasone • Datroway (datopotamab deruxtecan-dlnk)