Shots:
- FDA has approved Enhertu + THP for neoadj. treatment of adults with HER2+ Stage II/III breast cancer, & Enhertu monotx. for adj. treatment in adults with residual invasive disease post Herceptin (± Perjeta) & taxane-based therapy, triggering a $155M milestone payment from AZ to Daiichi Sankyo
- For neoadj. setting, approval was backed by DESTINY-Breast11 (n=927), showing Enhertu + THP demonstrated a pCR rate of 67.3% vs 56.3% for ddAC-THP. At the pCR analysis, 29 pts had EFS events & 12 had OS events; data was published in Annals of Oncology
- Adj. setting approval was backed by DESTINY-Breast05 (n=1,635), showing reduced risk of IDFS by 53% vs trastuzumab emtansine. At 3yrs., 92.4% pts in Enhertu arm were alive & free of invasive disease vs 83.7%, with 51 vs 102 events; data were published in The NEJM
Ref: AstraZeneca | Image: AstraZeneca and Daiichi Sankyo |Press Release
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