AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) in combination with pertuzumab has been recommended for approval in the European Union as a first-line treatment for adults with unresectable or metastatic HER2-positive breast cancer.

 

This marks a major milestone that could deliver the region's first new first-line treatment option for the disease in more than a decade.

 

The positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) was based on results from the Phase III DESTINY-Breast09 trial, which showed the Enhertu combination reduced the risk of disease progression or death by 44% compared with the current standard of care of taxane, trastuzumab and pertuzumab (THP).

 

Patients treated with Enhertu plus pertuzumab achieved a median progression-free survival of 40.7 months, compared with 26.9 months for those receiving THP, extending the period before disease progression by more than a year.

 

The progression-free survival benefit was consistent across patient subgroups, including hormone receptor status, de novo or recurrent disease, and PIK3CA mutation status. The safety profile of the combination was consistent with the known profiles of the individual medicines, with no new safety concerns identified.

 

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “HER2-positive metastatic breast cancer is an aggressive subtype, so starting patients on an effective HER2-targeted treatment early and continuing it for as long as they benefit can have a meaningful impact on long-term outcomes. 

 

"DESTINY-Breast09 sets a new benchmark with a median progression-free survival of more than three years, underscoring the potential of Enhertu plus pertuzumab to redefine first-line treatment for patients with HER2-positive metastatic breast cancer.”

 

John Tsai, Global Head, R&D, Daiichi Sankyo, said: “Enhertu in combination with pertuzumab improved progression-free survival by more than one year compared with the current first-line standard of care, representing a meaningful advantage early in the treatment of patients with metastatic HER2-positive disease. 

 

"Today’s positive CHMP opinion brings us closer to making Enhertu available in the EU as a first-line treatment option for eligible patients with HER2-positive metastatic breast cancer, marking an important milestone in moving this medicine earlier in the treatment pathway.”