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AstraZeneca and Daiichi Sankyo’s Enhertu Approved in EU for Advanced Non-Small Cell Lung Cancer

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AstraZeneca and Daiichi Sankyo have received approval from the European Commission for Enhertu, a targeted treatment for adult patients with advanced non-small cell lung cancer (NSCLC) with specific HER2 mutations. The approval comes after positive results from the DESTINY-Lung02 Phase II trial, where Enhertu demonstrated a 49% objective response rate (ORR) and a median duration of response of 16.8 months in previously treated patients.

Enhertu is a HER2-directed antibody-drug conjugate (ADC) developed collaboratively by AstraZeneca and Daiichi Sankyo. It offers a promising treatment option for patients with advanced NSCLC who have HER2 mutations and require systemic therapy following platinum-based chemotherapy, with or without immunotherapy.

The approval by the European Commission aligns with the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) and is based on data from the DESTINY-Lung02 trial, which was presented at the IASLC 2023 World Conference on Lung Cancer and published in the Journal of Clinical Oncology.

In the trial, Enhertu demonstrated a robust 49% ORR, including one complete response and 48 partial responses. The median duration of response was 16.8 months, showcasing the therapy’s efficacy in this patient population.

Dr. Martin Reck, Head of the Department of Thoracic Oncology at Lung Clinic Grosshansdorf, Germany, highlighted the significance of this approval for patients with HER2-mutant NSCLC. He noted that this marks a crucial step forward in treating a disease that has limited treatment options and often leads to poor outcomes.

Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Business Unit, emphasized the importance of understanding the molecular drivers of lung cancer. He mentioned that Enhertu’s approval as the first HER2-directed option for HER2-mutant NSCLC underscores the relevance of HER2 as a therapeutic target in lung cancer.

Ken Keller, Global Head of Oncology Business and President and CEO of Daiichi Sankyo, Inc., expressed their commitment to expanding the accessibility of Enhertu to patients with HER2-targetable tumors. This approval marks Enhertu as the first ADC approved for lung cancer in the EU and extends its usage to three different tumor types.

The DESTINY-Lung02 trial also confirmed that Enhertu’s safety profile was consistent with previous clinical trials, with no new safety concerns identified.

In financial terms, AstraZeneca will make a $75 million milestone payment to Daiichi Sankyo following the EU approval for this indication. Sales of Enhertu in most EU territories will be recognized by Daiichi Sankyo, while AstraZeneca will report its share of gross profit margin from Enhertu sales in those territories as alliance revenue.

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