AstraZeneca and Daiichi Sankyo’s Enhertu Receives the NMPA’s Conditional Approval to Treat Gastric Cancer
Shots:
- The conditional approval of Enhertu (6.4mg/kg) as monotx. to treat locally advanced or metastatic HER2+ve G/GEJ adenocarcinoma was supported by its P-II (DESTINY-Gastric06) study vs Pt-based CT among previously treated Chinese patients (n=95). Full approval depends upon the confirmatory study
- Study demonstrated cORR of 28.8% & mPFS of 5.7mos. with a safety profile aligning with prior studies and without any new signals
- The P-II (DESTINY-Gastric01) study of Enhertu vs CT in G/GEJ cancer patients (n=188) across Japan & South Korea also supported the approval, showing improved cORR of 40.5% vs 11.3% & mOS of 12.5mos. vs 8.4mos.
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