Enhertu with pertuzumab approved in the EU as first-line treatment for HER2-positive metastatic breast cancer

Daiichi Sankyo/Enhertu

The European Union approved Enhertu (trastuzumab deruxtecan) taken with pertuzumab as a first-line treatment for adults with unresectable or metastatic HER2-positive breast cancer, following a positive CHMP opinion. The approval rests on the DESTINY-Breast09 Phase 3 trial, which compared the combination with the standard taxane, trastuzumab and pertuzumab regimen.

• The trial enrolled 1,157 patients, randomised 1:1:1 to Enhertu alone, Enhertu with pertuzumab, or the standard regimen.
• Enhertu with pertuzumab reduced the risk of progression or death by 44% (hazard ratio 0.56).
• Median progression-free survival was 40.7 months with the combination vs 26.9 months with the standard regimen.
• The release says the safety profile was consistent with each drug's known profile, with no new safety concerns.
• A separate EU review covers HER2-positive breast cancer with residual disease after neoadjuvant treatment (DESTINY-Breast05).