CHMP Recommends Durvalumab Combination for EU Approval in Resectable NSCLC

A durvalumab (Imfinzi)-based perioperative regimen has been recommended by the EMA Committee for the treatment of adults with resectable non-small cell lung cancer. The recommendation is based on results from the AEGEAN trial, which showed that durvalumab reduced the risk of recurrence, or death by 32% compared to neoadjuvant chemotherapy alone.

AstraZeneca announced that durvalumab in combination with chemotherapy has been recommended for approval in the European Union (EU) for the treatment of adults with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence, who do not have epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. Under this regimen, patients receive durvalumab plus neoadjuvant chemotherapy before surgery, followed by adjuvant durvalumab monotherapy after surgery.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the pivotal AEGEAN trial, which were published in The New England Journal of Medicine.

“Adding perioperative durvalumab to neoadjuvant chemotherapy significantly improved outcomes for patients with resectable NSCLC, who experience high rates of recurrence and poor outcomes. Today’s recommendation marks an important step towards patients and their clinicians in Europe gaining access to an innovative treatment that should become a backbone combination approach in this curative-intent setting,” said Professor Martin Reck, Head of the Department of Thoracic Oncology at the Lung Clinic Grosshansdorf.

Key Results:

The AEGEAN trial was a global, randomized, double-blind, placebo-controlled study, evaluating durvalumab in combination with neoadjuvant chemotherapy before surgery, followed by adjuvant durvalumab monotherapy.

• Event-Free Survival (EFS): A planned interim analysis (32% data maturity) showed a 32% risk reduction in recurrence, progression, or death (HR = 0.68; 95% CI: 0.53-0.88; p=0.003902).
• Pathologic Complete Response (pCR): 17.2% of patients receiving Imfinzi plus chemotherapy achieved a pCR, compared to 4.3% with chemotherapy alone.
• Overall Survival (OS): A favorable trend was observed, but results are not yet statistically tested (HR=0.89; 95% CI: 0.70-1.14).

Safety Profile

The combination of Imfinzi plus chemotherapy was generally well tolerated, with no unexpected safety signals. Additionally, clinicians reported that the regimen did not compromise surgical feasibility compared to neoadjuvant chemotherapy alone.