Single-center phase 2 trial of trastuzumab deruxtecan for HER-2 positive breast cancer with active brain metastases: final outcomes of TUXEDO-1

The phase 2 TUXEDO-1 trial, at the Medical University of Vienna (Austria), evaluated the antibody-drug conjugate trastuzumab deruxtecan (T-DXd) in 15 adult patients with active brain metastases from HER2-positive breast cancer, and found intracranial response in 73.3% of patients (published in 2022). Final survival results of the trial have now been published. At 26.5 months median follow-up, median progression-free survival was 21 months (95% CI 13.3-NR) and median overall survival was not reached (22.2-NR). No new safety signals were observed. The most common grade 3 adverse event was fatigue, in 20% of patients. Grade 2 interstitial lung disease and grade 3 symptomatic drop of left-ventricular ejection fraction were observed in one patient each. Quality of life was maintained over the treatment period. The authors conclude that T-DXd showed long-term activity in patients with active brain metastases from HER2-positive breast cancer.