AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved by the European Commission (EC) as the first HER2-directed therapy for a subset of lung cancer patients.
The EU regulator’s decision specifically applies to adults with advanced non-small cell lung cancer (NSCLC) whose tumours have an activating HER2 mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.
The approval follows a recommendation from the European Medicines Agency’s human medicines committee and is supported by results from the mid-stage DESTINY-Lung02 trial, in which Enhertu demonstrated a confirmed objective response rate of 49% and a median duration of response of 16.8 months in previously-treated patients with advanced or metastatic HER2-mutant NSCLC.
Lung cancer is the third most commonly diagnosed cancer in Europe, with more than 477,000 cases diagnosed in 2020. NSCLC accounts for approximately 85% of all lung cancer diagnoses.
HER2 is a growth-promoting protein expressed on the surface of multiple tumour types. Certain HER2 gene alterations have been identified in patients with non-squamous NSCLC as a distinct molecular target and occur in up to 4% of patients with this type of lung cancer.
Dave Fredrickson, executive vice president, oncology business unit, AstraZeneca, said: “Understanding the molecular drivers behind a lung cancer diagnosis is critical, and while there are now targeted options for many patients, those with HER2-mutant NSCLC have had few treatment options, none of which have been approved to treat their specific type of lung cancer.
“Enhertu is the first HER2-directed option approved for HER2-mutant disease and confirms the relevance of HER2 as a target in lung cancer.”
Enhertu is also approved in major markets, including the EU, to treat certain breast and gastric cancers.
Ken Keller, global head of oncology business and president and chief executive officer of Daiichi Sankyo, said: “Since our initial approval of Enhertu for metastatic breast cancer in the EU more than two years ago, we have remained committed to bringing this innovative antibody drug conjugate to more patients with HER2-targetable tumours, especially those that have previously not been eligible for treatment with a HER2-directed therapy.”