ASTRAZENECA PLC (AZN) Form 6-K — Sep 1, 2026
AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) in combination with pertuzumab has been approved in the EU for the first-line treatment of adults with unresectable or metastatic HER2-positive breast cancer, the first new regimen in this setting in more than a decade. The European Commission decision follows a positive CHMP opinion and is based on the DESTINY-Breast09 Phase III trial. In DESTINY-Breast09, the combination reduced the risk of disease progression or death by 44% versus THP (hazard ratio 0.56; p<0.00001), with median progression-free survival of 40.7 months versus 26.9 months for the standard of care.
Key figures
- P Value
- <0.00001
- Enhertu Dose
- 5.4 mg/kg
- Hazard Ratio
- 0.56
- Trial Enrollment
- 1157
- Milestone Payment Usd
- 100000000
- Risk Reduction Percent
- 44
- Median Pfs Months Control THP
- 26.9
- Median Pfs Months Combination
- 40.7
- Hazard Ratio Confidence Interval
- 0.44-0.71
- Countries Approved1 LCombination
- more than 40
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