Daiichi Sankyo Submits Marketing Authorization Application to EMA for Trastuzumab Deruxtecan in HER2-Low Metastatic Breast Cancer
Daiichi-Sankyo
Pharmaceutical R&D Developer
European Medicines Agency
The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU), located in London. It began operations in 1995. The agency is responsible for the scientific evaluation, supervision, and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. By ensuring that all medicines available on the EU market are safe, effective, and of high quality, the EMA protects public and animal health in the 28 EU Member States and countries of the European Economic Area.
On June 22, Daiichi Sankyo announced that it had submitted a marketing application to the European Medicines Agency (EMA) for trastuzumab deruxtecan (Enhertu, T-Dxd) as a monotherapy for the treatment of patients with unresectable or metastatic HER2-low (IHC1+ or IHC2+/ISH-) breast cancer who have previously received systemic therapy or experienced disease recurrence during or within six months of completing adjuvant chemotherapy. The application has been acknowledged by the EMA and the scientific review process has been initiated by the EMA’s Committee for Medicinal Products for Human Use (CHMP).
This application is primarily based on the DESTINY-Breast04 study. At the recently concluded 2022 ASCO meeting, the results of the DESTINY-Breast04 study were announced and simultaneously published in The New England Journal of Medicine.
DESTINY-Breast04 results show that trastuzumab deruxtecan demonstrated superior progression-free survival and overall survival benefits compared to chemotherapy.
Specifically, in the HR+ and overall populations, the mPFS for the T-DXd group was 10.1 months and 9.9 months, respectively, and the mOS was 23.9 months and 23.4 months, respectively, significantly better than the control group.
In terms of exploratory endpoints, in the HR- population, the mPFS for the T-DXd group and the TPC group were 8.5 months and 2.9 months, respectively (HR=0.46); the mOS for the T-DXd group and the TPC group were 18.2 months and 8.3 months, respectively (HR=0.48).
In terms of safety, the median treatment duration was 8.2 months in the T-DXd group and 3.5 months in the TPC group; the most common adverse events leading to treatment discontinuation were ILD/pneumonia (8.2%) in the T-DXd group and peripheral sensory neuropathy (2.3%) in the TPC group; the most common adverse events leading to dose reduction were nausea and fatigue (4.6%) in the T-DXd group and neutropenia (14.0%) in the TPC group.
Special drug-related adverse reactions —— ILD/pneumonia, 12.1% in the T-DXd group and 0.6% in the TPC group. Left ventricular dysfunction, 4.3% in the T-DXd group and 0.5% in the TPC group.
Overall, the DESTINY-Breast04 study met its primary and secondary endpoints, with all subgroups benefiting, including groups with various levels of HER2 IHC and those previously treated with CDK4/6 inhibitors. No new safety signals were identified.
Author: Shuye
*Disclaimer: This article was written by an author who has settled in Sina Medicine News. The views expressed represent those of the author and do not reflect the position of Sina Medicine News.
