(Breast Cancer) Is Enhertu Effective for Brain Metastases?

Enhertu in HER2-Positive Breast Cancer with Brain Metastases — TUXEDO-1 Trial

On August 8, 2022, Rupert Bartsch and colleagues at the Medical University of Vienna published in the medical journal Nature Medicine the efficacy and safety results of the TUXEDO-1 Phase 2 trial evaluating Enhertu (trastuzumab deruxtecan) in patients with HER2-positive breast cancer with brain metastases.

Trial Design

The TUXEDO-1 Phase 2 trial administered Enhertu (5.4 mg/kg, 3-week cycles) to 15 patients with HER2-positive breast cancer with brain metastases who had either received no prior treatment or had prior treatment. The primary endpoint was intracranial response rate.

Patient characteristics: 60% of patients had developed brain metastases during disease progression on prior treatment; 14 female and 1 male patient; median age 69 years (range 30–76); ECOG performance status 0 in 40%; 12 patients had hormone receptor-positive disease.

Efficacy Results

• Intracranial response rate (primary endpoint): 73.3% (N=11/15)
  • Complete response: 13.3% (N=2)
  • Partial response: 60% (N=9)
  • Stable disease: 20% (N=3)
• Median progression-free survival: 14 months

Conclusions

Based on the TUXEDO-1 trial results, Rupert Bartsch and colleagues concluded that Enhertu demonstrated a high intracranial response rate in patients with HER2-positive breast cancer with brain metastases.

Source: https://www.nature.com/articles/s41591-022-01935-8

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