EMA recommends new first-line treatment for HER2-positive breast cancer

The European Medicines Agency (EMA) has issued a positive opinion for the use of trastuzumab deruxtecan (T-DXd, Enhertu) in combination with pertuzumab as a first-line treatment for adult patients with unresectable or metastatic HER2-positive breast cancer.

This development is based on the results of the Phase III DESTINY-Breast09 randomized study. The study compared the combination of trastuzumab deruxtecan and pertuzumab against the current standard first-line regimen, taxane–trastuzumab–pertuzumab (THP). The findings showed a median progression-free survival (PFS) of 40.7 months with the new combination, compared to 26.9 months with THP. Additionally, the relative risk of disease progression or death was reduced by 44%, and the objective response rate was 85.1%.

Medical experts from the Therapeutic Clinic of Alexandra Hospital and the Medical School of the National and Kapodistrian University of Athens noted that these advancements in targeted therapies, such as antibody-drug conjugates (ADCs) and CDK4/6 inhibitors, are significantly altering the treatment landscape for metastatic breast cancer.