Key Takeaways
- The FDA has granted Priority Review to Enhertu for the treatment of HER2-low and HER2-ultralow metastatic breast cancer, based on positive results from the DESTINY-Breast06 Phase III trial.
- Enhertu demonstrated a 37% reduction in the risk of disease progression or death compared to chemotherapy, offering a median progression-free survival of 13.2 months in both HER2-low and HER2-ultralow patients.
- If approved, Enhertu would become the first HER2-directed therapy for metastatic breast cancer patients with HER2-low or HER2-ultralow expression, before receiving chemotherapy.
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been granted Priority Review by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with unresectable or metastatic HER2-low or HER2-ultralow breast cancer who have received at least one line of endocrine therapy. This review is based on the positive results from the DESTINY-Breast06 Phase III trial, which demonstrated a statistically significant and clinically meaningful progression-free survival (PFS) benefit for Enhertu compared to chemotherapy.
The FDA’s Priority Review is given to medicines that show significant improvements over available treatments. If approved, Enhertu would be the first HER2-directed antibody-drug conjugate (ADC) available for patients before receiving chemotherapy for metastatic breast cancer. The FDA’s decision is expected during the first quarter of 2025.
In addition to Priority Review, Enhertu has also been granted Breakthrough Therapy Designation (BTD) by the FDA. This designation is intended to accelerate the development and regulatory review of therapies that address serious conditions and meet significant unmet medical needs.
Enhertu Demonstrates 37% Reduction in Disease Progression Risk for HER2-Low and HER2-Ultralow Breast Cancer
The DESTINY-Breast06 trial, which was presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The New England Journal of Medicine, showed that Enhertu reduced the risk of disease progression or death by 37% compared to chemotherapy. Patients treated with Enhertu had a median progression-free survival of 13.2 months versus 8.1 months with chemotherapy.
These results were consistent across patients with both HER2-low and HER2-ultralow expression. In HER2-low patients, Enhertu achieved a median PFS of 13.2 months, compared to 8.1 months for chemotherapy. In HER2-ultralow patients, Enhertu showed a similar benefit, with a median PFS of 13.2 months compared to 8.3 months for chemotherapy.
Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, commented on the potential impact of Enhertu: “The results from DESTINY-Breast06 demonstrate Enhertu’s ability to potentially reshape the treatment landscape for HR-positive metastatic breast cancer, offering a targeted option for patients with HER2-low or HER2-ultralow expression after endocrine therapy.”
Enhertu’s Priority Review Marks Potential Expansion for HER2-Low and HER2-Ultralow Breast Cancer Treatment
Ken Takeshita, Global Head of R&D at Daiichi Sankyo, added: “This Priority Review highlights Enhertu’s potential to expand its indication in HER2-low metastatic breast cancer and include patients with HER2-ultralow expression, offering a broader group of patients access to this therapy.”
The safety profile of Enhertu in the DESTINY-Breast06 trial was consistent with previous studies, with no new safety concerns identified. Enhertu has already been approved in more than 65 countries for patients with HER2-low metastatic breast cancer based on earlier clinical trial results.
With the potential approval of this new indication, Enhertu could provide a significant advancement in treatment options for patients with metastatic breast cancer, offering targeted therapy before chemotherapy is required. This marks a critical step forward in addressing the unmet needs of patients with HER2-low or HER2-ultralow breast cancer.
Resource: AstraZeneca, October 01, 2024
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