
Astrazeneca's Enhertu cuts progression risk 44%
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- EU regulators recommended Enhertu plus pertuzumab for first-line treatment of HER2-positive metastatic breast cancer.
- The combination reduced disease progression or death risk by 44% compared with standard THP treatment.
- The European Commission will now review the recommendation before deciding on EU approval.
Daiichi Sankyo and AstraZeneca (NASDAQ:AZN) secured an EU recommendation after Enhertu cut progression risk by 44%.
Median progression-free survival reached 40.7 months with Enhertu plus pertuzumab, versus 26.9 months with standard THP treatment.
“Enhertu in combination with pertuzumab improved progression-free survival by more than one year,” said Daiichi Sankyo Global Head of R&D John Tsai.
Response rates were 85.1% versus 78.6%, while lung inflammation occurred in 12.1%, including two fatal cases.
The European Commission will review the opinion.
Following the announcement, AstraZeneca's share price was down 0.9% at $168.27.
The combination is already approved in the U.S. and several other markets for eligible first-line patients.
Enhertu is also under EU review for residual HER2-positive breast cancer after treatment given before surgery.