Enhertu gains EU approval for breast cancer

• The European Union approved Enhertu plus pertuzumab for first-line HER2-positive metastatic breast cancer treatment.
• Phase 3 DESTINY-Breast09 data showed a 44% reduction in disease progression or death risk versus THP.
• The combination achieved median progression-free survival of 40.7 months compared with 26.9 months for THP.

AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo received European Union approval for Enhertu (trastuzumab deruxtecan) combined with pertuzumab as a first-line treatment for adults with unresectable or metastatic HER2-positive breast cancer.

The approval was based on Phase 3 DESTINY-Breast09 trial results, which showed Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% compared with taxane, trastuzumab, and pertuzumab (THP).

“Today’s results, coming just days after FDA approval of the HERIZON-GEA-01 regimens, add to a series of important milestones demonstrating their potential to transform the treatment of HER2-positive GEA,” said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeOne Medicines.

In DESTINY-Breast09, Enhertu plus pertuzumab produced median progression-free survival of 40.7 months compared with 26.9 months for THP, with an objective response rate of 85.1% versus 78.6% among 383 evaluated patients.

The European Commission approval follows positive regulatory review, while following the announcement the AstraZeneca share price was not provided.

Enhertu is a HER2-directed antibody-drug conjugate developed by Daiichi Sankyo and jointly developed and commercialized with AstraZeneca for multiple cancer indications.

Daiichi Sankyo said AstraZeneca will pay a $100 million milestone payment following the EU approval, while Enhertu plus pertuzumab is now approved in more than 40 countries and regions for first-line HER2-positive metastatic breast cancer.