AstraZeneca’s Imfinzi (durvalumab) plus chemotherapy combo has received the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommendation for approval in the European Union (EU) to treat adults with resectable non-small-cell lung cancer (NSCLC).
The recommendation is intended for subjects at high risk of recurrence without epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements.
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Subjects on this regimen in combination with neoadjuvant chemotherapy before surgery and an adjuvant monotherapy post-surgery.
The decision is supported by the outcomes from the AEGEAN trial.
AstraZeneca oncology haematology research and development executive vice-president Susan Galbraith stated: “This recommendation highlights the potential of Imfinzi to address an unmet need for patients with resectable lung cancer who need new treatment options that increase the time they live without recurrence or progression.
“AEGEAN underscores our commitment to transforming care in the early stages of lung cancer where there is the greatest potential for cure.”
In subjects treated with the Imfinzi-based perioperative regimen, the planned interim analysis findings of event-free survival demonstrated a 32% decrease in the recurrence, progression or mortality risk in comparison with neoadjuvant chemotherapy alone.
Imfinzi was generally well-tolerated, with no new safety signals identified in the neoadjuvant and adjuvant settings.
The combination therapy did not affect the patient’s ability to complete surgery when compared to chemotherapy alone.
Already approved in several countries including the US, this human monoclonal antibody is also under regulatory review in China and Japan.
Imfinzi attaches to the programmed cell death ligand 1 protein, disrupting the tumour’s immune-evasion tactics and enhancing immune responses.
The company’s Tagrisso and Imfinzi recently gained recommendations from England’s National Institute for Health and Care Excellence for use within England and Wales’ National Health Service.
