LONDON (dpa-AFX) - AstraZeneca (AZN, AZN.L) and Daiichi Sankyo (DSKYF.PK) announced that positive results from the DESTINY-Gastric04 phase 3 trial showed ENHERTU (trastuzumab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) compared to ramucirumab plus paclitaxel in patients with second-line HER2 positive (IHC 3+ or IHC 2+/ISH+) unresectable and/or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.
In the primary endpoint analysis of overall survival, ENHERTU reduced the risk of death by 30% versus ramucirumab plus paclitaxel. Median overall survival was 14.7 months with ENHERTU versus 11.4 months with ramucirumab plus paclitaxel (n=248).
In the secondary endpoint analysis of progression-free survival (PFS), ENHERTU demonstrated a 26% reduction in the risk of disease progression or death versus ramucirumab plus paclitaxel as assessed by investigator. Median PFS was 6.7 months with ENHERTU versus 5.6 months with ramucirumab plus paclitaxel.
The safety profile of ENHERTU in DESTINY-Gastric04 was consistent with previous gastric cancer clinical trials with no new safety concerns identified.
ENHERTU is currently approved in more than 70 countries in the second-line or third-line metastatic setting of HER2 positive gastric cancer based on DESTINY-Gastric01, a randomized phase 2 trial, and DESTINY-Gastric02 and DESTINY-Gastric06, two single-arm phase 2 trials.
Daiichi Sankyo and AstraZeneca are currently evaluating ENHERTU in the first-line metastatic setting through the DESTINY-Gastric05 and ARETEMIDE-Gastric01 phase 3 trials.
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