Clinical Report: Advancements in Research and Clinical Use of Datopotamab Deruxtecan

Overview

Datopotamab deruxtecan (Dato-DXd) is a TROP2-targeting antibody-drug conjugate. Recent clinical trials have reported its efficacy in treating advanced breast cancer and non-small cell lung cancer.

Background

The development of antibody-drug conjugates (ADCs) has transformed cancer therapy for solid tumors. Datopotamab deruxtecan targets TROP2, a protein overexpressed in many solid tumors.

Data Highlights

Datopotamab deruxtecan has demonstrated efficacy in clinical trials, including:

Key Findings

• FDA approved Dato-DXd for unresectable or metastatic HR-positive, HER2-negative breast cancer on January 17, 2025.
• In TROPION-Breast01, Dato-DXd showed a median progression-free survival (PFS) of 6.9 months compared to 4.9 months with chemotherapy.
• For EGFR-mutated non-small cell lung cancer (NSCLC), Dato-DXd received accelerated approval on June 23, 2025, based on a pooled subgroup showing an overall response rate (ORR) of 45%.
• In TROPION-Breast02, Dato-DXd demonstrated a PFS of 10.8 months versus 5.6 months with chemotherapy for triple-negative breast cancer (TNBC).
• Common adverse reactions include stomatitis, nausea, fatigue, and ocular events.

Clinical Implications

Clinicians should consider the efficacy and safety profile of datopotamab deruxtecan when evaluating treatment options for patients with advanced cancers.

Conclusion

Datopotamab deruxtecan is a treatment option for solid tumors, particularly in breast cancer and NSCLC.

Related Resources & Content

1. FDA, FDA, 2025 -- FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic HR-positive, HER2-negative breast cancer
2. FDA, FDA, 2025 -- FDA grants accelerated approval to datopotamab deruxtecan-dlnk for EGFR-mutated non-small cell lung cancer
3. FDA, FDA, 2026 -- FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic triple-negative breast cancer
4. ADA News — Datopotamab Deruxtecan Shows Activity in Advanced Triple-Negative Breast Cancer
5. The ASCO Post — Datopotamab Deruxtecan Shows Activity in Advanced Triple-Negative Breast Cancer
6. The ASCO Post — Expert Point of View: Debu Tripathy, MD, and Hope S. Rugo, MD, FASCO
7. the asco post — Datopotamab Deruxtecan in Advanced or Metastatic NSCLC With Actionable Genomic Alterations
8. Datopotamab Deruxtecan Shows Activity in Advanced Triple-Negative Breast Cancer
9. Expert Point of View: Debu Tripathy, MD, and Hope S. Rugo, MD, FASCO
10. FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic, HR-positive, HER2-negative breast cancer | FDA
11. FDA grants accelerated approval to datopotamab deruxtecan-dlnk for EGFR-mutated non-small cell lung cancer | FDA
12. FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic triple-negative breast cancer | FDA
13. Datroway | European Medicines Agency (EMA)
14. Datopotamab Deruxtecan Does Not Meet Its Secondary Primary Endpoint in TROPION-Lung01, But Researchers Believe Therapy is Still Beneficial for Some Patients with Non-Squamous NSCLC  | IASLC
15. Datopotamab Deruxtecan in Advanced or Metastatic Non–Small Cell Lung Cancer With Actionable Genomic Alterations: Results From the Phase II TROPION-Lung05 Study - PMC
16. NCCN NSCLC 2026: An Update on Preferred Regimens - POCN
17. Non-Small Cell Lung Cancer, Version 4.2026, NCCN Clinical Practice Guidelines In Oncology | VALIANT | Vanderbilt University
18. Key breast cancer highlights from the 2025 European Society for Medical Oncology (ESMO) Congress - Rizk - Breast Communications
19. Datopotamab Deruxtecan-dlnk - NCI