European Commission approves new HER2-positive breast cancer treatment

The European Commission has approved the combination of trastuzumab deruxtecan and pertuzumab as a first-line treatment for adult patients with unresectable or metastatic HER2-positive breast cancer. This approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) and is based on results from the phase 3 DESTINY-Breast09 clinical trial.

The trial, which included patients who had not previously received chemotherapy or HER2-targeted treatment (or had received such treatment more than six months prior), demonstrated a 44% reduction in the risk of disease progression or death compared to the standard treatment of taxane, trastuzumab, and pertuzumab (THP).

Key clinical findings include a median progression-free survival of 40.7 months for the combination therapy, compared to 26.9 months for the standard THP regimen. Additionally, the objective response rate for the combination was 85.1%, exceeding the 78.6% observed with the standard treatment. The antibody-drug conjugate is being developed and marketed through an alliance between Daiichi Sankyo and AstraZeneca.