The DESTINY-Breast06 Phase III trial yielded encouraging results, demonstrating the effectiveness of Enhertu (trastuzumab deruxtecan) in improving progression-free survival (PFS) significantly and meaningfully compared to standard chemotherapy. This positive outcome was observed in patients with HR-positive, HER2-low metastatic breast cancer after one or more lines of endocrine therapy.
The study, encompassing a primary trial population and an overall trial population, revealed a notable enhancement in PFS across both groups. Subgroup analysis further confirmed consistent benefits among patients expressing HER2-low and HER2-ultralow levels.
While data on overall survival (OS) remain premature, preliminary findings hint at a potential OS advantage with Enhertu compared to standard chemotherapy, particularly in patients with HER2-low metastatic breast cancer and across the entire trial population. The trial will persist to assess OS and other secondary endpoints.
Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, expressed optimism about Enhertu potentially becoming a new treatment standard for patients with HER2-low and HER2-ultralow metastatic breast cancer, highlighting its potential across HR-positive breast cancer spectrum.
Ken Takeshita, Global Head of R&D at Daiichi Sankyo, emphasized the significance of challenging existing treatment paradigms and breast cancer classifications, hinting at the potential broader use of Enhertu earlier in the treatment landscape.
Enhertu, a HER2-directed antibody drug conjugate, has shown consistent safety profiles across various breast cancer clinical trials, without any new safety concerns.
The detailed findings will be presented at upcoming medical meetings and shared with global regulatory authorities.
The DESTINY-Breast06 trial, a global Phase III study, evaluated Enhertu against standard chemotherapy in patients with HR-positive, HER2-low or HER2-ultralow advanced or metastatic breast cancer. The trial’s primary endpoint was PFS in the HR-positive, HER2-low patient population, with key secondary endpoints including OS in patients with HER2-low expression and various other measures.
Breast cancer, being a leading cause of cancer-related deaths globally, poses a significant challenge. HER2 expression plays a crucial role in breast cancer classification and treatment decisions. Prior to Enhertu’s approval in HER2-low metastatic breast cancer, there were no targeted therapies specifically approved for this patient population.
Enhertu, developed by Daiichi Sankyo and jointly developed and commercialized by AstraZeneca and Daiichi Sankyo, has received approvals in various countries for the treatment of HER2-positive and HER2-low breast cancer, as well as other cancer types.
AstraZeneca, with its robust portfolio and pipeline, aims to redefine breast cancer treatment paradigms and ultimately eliminate breast cancer as a cause of death. The company continues to explore innovative treatments across different breast cancer subtypes and stages, collaborating with Daiichi Sankyo and other partners to deliver impactful therapies to patients in need.
