▎WuXiEdited by Kant Content Team

Today, AstraZeneca and Daiichi Sankyo reported detailed positive results from the Phase 3 clinical trial DESTINY-Breast06 at the American Society of Clinical Oncology (ASCO) Annual Meeting. The data showsThe重磅 antibody-drug conjugate (ADC) Enhertu significantly improved progression-free survival (PFS) in patients with HR-positive, HER2-low (IHC 1+ or 2+/ISH-) metastatic breast cancer compared to standard chemotherapy.This improvement was also confirmed in the overall trial population, including patients who are HR-positive, HER2-low, and HER2-ultralow (defined as IHC 0, with membranous staining). Dr. Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, stated in a press release that this result could lead to a paradigm shift in breast cancer treatment.

In the overall trial population, Enhertu reduced the risk of disease progression or death by 37% compared to chemotherapy., with a median PFS of 13.2 months compared to 8.1 months in the chemotherapy group (HR=0.63; 95% CI: 0.53-0.75; p<0.0001).

In addition, pre-specified exploratory analyses showed,Consistent, clinically significant improvements in PFS were observed in patients with HER2-low and HER2-ultralow expression.In patients with HER2 ultra-low expression, Enhertu reduced the risk of disease progression or death by 22%, with a median PFS of 13.2 months compared to 8.3 months in the chemotherapy group (HR=0.78; 95% CI: 0.50-1.21). In the Enhertu group, 13 complete responses were observed, including 9 in patients with HER2 low expression. In the HER2 ultra-low expression subgroup, there were 4 complete responses in the Enhertu group, while no complete responses were observed in the chemotherapy group.For detailed data, please see the table below:

▲Summary of DESTINY-Breast06 Trial Data (Source:Reference [1])

The two companies also reported additional clinical trial data for Enhertu at the ASCO Annual Meeting. In DESTINY-Breast03, Enhertu continued to demonstrate clinically meaningful survival improvement compared to the active control ADC in treating HER2-positive unresectable or metastatic breast cancer patients over three years of follow-up. The median OS was 52.6 months in the Enhertu group and 42.7 months in the active control group (HR=0.73; 95% CI: 0.56-0.94).

Enhertu is an ADC therapy jointly developed by AstraZeneca and Daiichi Sankyo. It is designed using Daiichi Sankyo's proprietary DXd ADC technology platform, consisting of a humanized monoclonal antibody targeting HER2 linked to a topoisomerase 1 inhibitor payload via a cleavable tetrapeptide linker. Enhertu received its first approval from the U.S. FDA in 2019.Approval, for the treatment of patients with unresectable or metastatic HER2-positive breast cancer.

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