ArticleJournal of clinical pharmacology2026
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.
Article in Journal of clinical pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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10 authors.
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Abstract
Dato-DXd (datopotamab deruxtecan) is an anti-TROP2 antibody-drug conjugate developed for the treatment of unresectable or metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer (HR+/HER2-BC) who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease. Associations between Dato-DXd or its payload DXd pharmacokinetics (PK) and various efficacy and safety endpoints were investigated in the current analysis. Exposure-efficacy analysis was conducted in a total of 352 patients with HR+/HER2-BC who received Dato-DXd at 6 mg/kg every 3 weeks (Q3W). Area under the curve in cycle 1 (AUC1) was identified as a significant covariate of overall survival (OS), with higher Dato-DXd exposure associated with longer OS. Progression-free survival (PFS) showed a positive trend with higher exposure, though baseline tumor size emerged as a more significant predictor in multivariable analyses. Exposure-safety analysis revealed correlations between higher Dato-DXd or DXd PK metrics and increased risk of selected safety events, including stomatitis and ocular surface events. PopPK analysis showed that Dato-DXd exposure increased with body weight, and implementing a capped dose of 540 mg for patients ≥90 kg helped normalize exposure across weight groups. Exposure-safety analysis further supported that this approach may reduce the potential associated safety risks. These results support the recommended Dato-DXd dosing regimen (6 mg/kg Q3W with dose capping for patients ≥90 kg) and highlight its favorable benefit-risk profile in patients with HR+/HER2-breast cancer.
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