Enhertu plus pertuzumab has received European Union approval for HER2 positive metastatic breast cancer treatment. The approval covers first-line treatment for eligible adult patients.
The European Commission based its decision on results from the DESTINY-Breast09 phase 3 trial. The study evaluated Enhertu with pertuzumab in patients with unresectable or metastatic disease. Enhertu is a HER2-directed DXd antibody drug conjugate developed by Daiichi Sankyo. Daiichi Sankyo and AstraZeneca jointly develop and commercialize the medicine.
The treatment reduced the risk of disease progression or death by 44% versus THP. Median progression-free survival reached 40.7 months with the combination. By comparison, patients receiving THP recorded median progression-free survival of 26.9 months. The combination also produced an 85.1% confirmed objective response rate.
“For patients diagnosed with HER2 positive metastatic breast cancer, maintaining disease control for as long as possible in the first-line setting is a critical treatment goal,” said Cristina Saura, MD, PhD, Vall d’Hebron University Hospital and Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Steering Committee Member and Investigator for the DESTINY-Breast09 trial. “The combination of trastuzumab deruxtecan and pertuzumab represents a significant therapeutic advance, with progression-free survival exceeding three years compared to approximately two years with the current standard of care, and has the potential to become the new first-line standard of care.”
Enhertu Plus Pertuzumab Shows Strong Clinical Results
The safety profile remained consistent with the known profiles of both treatments. No new safety concerns emerged from the DESTINY-Breast09 trial.
“This milestone marks the second new indication for Enhertu in the EU in just two months, following the recent tumor agnostic approval, underscoring our goal to bring this medicine to more eligible patients as quickly as possible,” said Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc. “This approval of Enhertu in combination with pertuzumab has the potential to reshape clinical practice in the first-line treatment setting for patients with HER2 positive metastatic breast cancer.”
“This approval brings Enhertu to patients in the EU earlier in the course of their metastatic disease and sets a new benchmark for progression-free survival in the first-line setting,” said Dave Fredrickson, Executive Vice President, Oncology Hematology Business Unit, AstraZeneca. “HER2 positive metastatic breast cancer is an aggressive disease, so to give patients the best chance of improving long-term outcomes, it is critical to initiate effective HER2 directed therapy early and continue treatment for as long as patients benefit.”
Fredrickson serves as Executive Vice President of AstraZeneca’s Oncology Hematology Business Unit. He emphasized the importance of early HER2-directed treatment. Based on DESTINY-Breast09 results, ESMO included the combination in its Clinical Practice Guidelines. It received a Category IA recommendation for first-line treatment. The recommendation applies regardless of hormone receptor status. Additionally, the combination now holds approval in more than 40 countries and regions. The EU decision marks another expansion for Enhertu in oncology. It also strengthens treatment options for patients with HER2 positive metastatic breast cancer.
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News Source: Businesswire.com
