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AstraZeneca : Enhertu Improves PFS In Phase 3 Trial On Metastatic Breast Cancer

AstraZeneca Plc. (AZN.L,AZN) and Daiichi Sankyo Company, Limited (DSKYF.PK) said that enhertu significantly improved progression-free survival in destiny-breast03 head-to-head phase 3 trial versus trastuzumab emtansine in patients with HER2 positive metastatic breast cancer.

The Independent Data Monitoring Committee (IDMC) recommended unblinding based on primary efficacy endpoint demonstrating superiority. The results also indicate strong trend toward improved overall survival.

In phase 3 trial, enhertu also showed a strong trend toward improved overall survival (OS) compared to trastuzumab emtansine in a key secondary endpoint, although the OS data are still immature. The safety profile of enhertu was consistent with previous clinical trials with no new safety concerns identified and no grade 4 or 5 treatment-related interstitial lung disease events.

DESTINY-Breast03 is a global, head-to-head, randomized, open-label, pivotal phase 3 trial evaluating the safety and efficacy of enhertu (5.4 mg/kg) versus trastuzumab emtansine in patients with HER2 positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane.

DESTINY-Breast03 enrolled approximately 500 patients at multiple sites in Asia, Europe, North America, Oceania and South America.

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