AstraZeneca's Stock Gain After Enhertu Meets Primary Endpoint In HER2-Low Breast Cancer Setting

AstraZeneca plc AZN said that Enhertu prolonged survival and slowed the progression of metastatic breast cancer with low levels of a protein known as HER2.

• Data from the pivotal DESTINY-Breast04 Phase 3 trial showed Enhertu (trastuzumab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) and overall survival (OS) in patients versus physician's choice of chemotherapy.
• The improvement was "clinically meaningful" when compared with standard chemotherapy, it said, adding that detailed results of the late-stage trial would be presented at an as-yet-undisclosed medical conference.
• Related: AstraZeneca-Daiichi Sankyo Share Detailed Enhertu Data In Gastric Cancer.
• Enhertu is a HER2-directed antibody-drug conjugate (ADC) jointly developed by AstraZeneca and Daiichi Sankyo DSNKY.
• The trial met the key secondary endpoint of PFS in patients with HER2-low metastatic breast cancer regardless of HR status.
• The safety profile of Enhertu was consistent with previous clinical trials, with no new safety concerns identified. 
• Overall interstitial lung disease (ILD) rates were consistent with that observed in late-line HER2-positive breast cancer trials of Enhertu, with a lower rate of Grade 5 ILD observed.
• Price Action: AZN shares are up 3.49% at $61.95 during the premarket session on the last check Tuesday.