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Patritumab deruxtecan in leptomeningeal metastatic disease of solid tumors: the phase 2 TUXEDO-3 trial.

Matthias Preusser1, Javier Garde-Noguera2,3, Juan José García-Mosquera4

  • 1Department of Medicine 1, Division of Oncology, Medical University of Vienna, Vienna, Austria. matthias.preusser@meduniwien.ac.at.

Nature Medicine
|May 30, 2025
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Summary

Patritumab deruxtecan (HER3-DXd) shows promising activity in patients with leptomeningeal disease (LMD), a severe cancer complication. This study indicates HER3-DXd offers clinical benefit and improved survival for LMD patients.

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Area of Science:

  • Oncology
  • Clinical Pharmacology
  • Cancer Metastasis

Background:

  • Leptomeningeal metastatic disease (LMD) is a severe complication of solid tumors with limited therapeutic options.
  • HER3 receptor is implicated in central nervous system metastases, making it a potential therapeutic target.
  • Patritumab deruxtecan (HER3-DXd), an antibody-drug conjugate, has shown efficacy in other cancers.

Purpose of the Study:

  • To investigate the efficacy and safety of patritumab deruxtecan (HER3-DXd) in patients with leptomeningeal metastatic disease (LMD).
  • To evaluate HER3-DXd's impact on survival, response rates, and quality of life in LMD patients within the TUXEDO-3 trial.

Main Methods:

  • Phase 2 clinical trial (TUXEDO-3, cohort 3) involving 20 evaluable patients with treatment-naive or post-radiotherapy LMD from solid tumors.
  • Patients received HER3-DXd 5.6 mg/kg intravenously every 3 weeks.
  • Primary endpoint was 3-month survival; secondary endpoints included overall response rate (ORR) and clinical benefit rate (CBR).

Main Results:

  • The primary endpoint was met, with 65.0% of patients alive at 3 months; 6-month overall survival was 58.9%.
  • ORR was 26.3% overall (11.1% intracranial, 30.8% extracranial); CBR was 47.4% overall (50.0% intracranial, 38.5% extracranial).
  • Neurological symptoms and quality of life remained stable or improved; no new neurological adverse events were observed. Common adverse events included anemia, nausea, and neutropenia.

Conclusions:

  • Patritumab deruxtecan (HER3-DXd) demonstrated clinically relevant activity and an acceptable safety profile in patients with leptomeningeal metastatic disease (LMD).
  • HER3-DXd offers a potential new treatment avenue for LMD, showing promising survival benefits and disease control.