ENHERTU demonstrated statistically significant and clinically meaningful improvement in overall survival in patients with HER2 positive metastatic gastric cancer at interim analysis of DESTINY-Gastric04 Phase 3 trial

CAR-T Digest - August 2020

Weekly Digest - March 2025

03 March 2025: ENHERTU demonstrated statistically significant and clinically meaningful improvement in overall survival in patients with HER2 positive metastatic gastric cancer at interim analysis of DESTINY-Gastric04 Phase 3 trial

ENHERTU (Trastuzumab deruxtecan) showed statistically significant and clinically meaningful improvement in overall survival (OS) versus Ramucirumab and Paclitaxel in the Phase 3 DESTINY-Gastric04 trial
The primary endpoint was met in second-line HER2-positive (IHC 3+ or IHC 2+/ISH+) patients with unresectable and/or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma
The Independent Data Monitoring Committee recommended unblinding the trial early due to ENHERTU’s superior efficacy
Gastric cancer has a poor prognosis, with a five-year survival rate of 5–10% in advanced stages and no prior HER2-directed second-line treatment demonstrating survival benefit in a phase 3 trial
ENHERTU is already approved in over 65 countries based on previous phase 2 trials, and these new results may support additional regulatory approvals