ArticleClinical and translational science2026
Optimal Dosage Justification for Datopotamab Deruxtecan in HR-Positive/HER2-Negative Breast Cancer Through Model-Informed Drug Development Approaches.
Article in Clinical and translational science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
2 citing papers in PubMed.
- Exposure-Response Analyses of Datopotamab Deruxtecan (Dato-DXd) in Patients with Hormone Receptor (HR) Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer.Journal of clinical pharmacology · 2026Article
- Optimal Dosage Justification for Datopotamab Deruxtecan in HR-Positive/HER2-Negative Breast Cancer Through Model-Informed Drug Development Approaches.Clinical and translational science · 2026Article
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Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Project Optimus has been reforming the dose selection and optimization paradigm in oncology. In this context, model-informed drug development (MIDD) approaches were utilized to validate the optimal dose selection of 6 mg/kg every 3 weeks (Q3W) for datopotamab deruxtecan (Dato-DXd) in patients with HR-positive/HER2-negative breast cancer (HR+/HER2- BC). A Tumor Growth Inhibition (TGI)-Progression-Free Survival (PFS) modeling framework was developed to assess the relationship between Dato-DXd PK exposure, tumor dynamics, and PFS, and support virtual trial simulations at different Dato-DXd dose levels. Simulations suggested that Dato-DXd at 6 mg/kg Q3W provide superior tumor control and improved PFS compared to a lower dose in patients with HR+/HER2- BC. This work underscores the importance of integrating advanced modeling techniques into the dose optimization paradigm.
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