The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of AstraZeneca's Imfinzi (durvalumab) in combination with neoadjuvant chemotherapy for the treatment of non-small cell lung cancer (NSCLC). This recommendation is based on the positive results from the Phase III AEGEAN trial, which demonstrated significant improvements in patient outcomes.
The AEGEAN trial evaluated the efficacy of Imfinzi combined with neoadjuvant chemotherapy, followed by adjuvant Imfinzi monotherapy, in patients with NSCLC. The study met its primary endpoints, showing a 32% reduction in the risk of disease recurrence, progression, or death compared to chemotherapy alone.
Specifically, patients receiving the Imfinzi-based regimen experienced a median event-free survival (EFS) that was not reached, whereas the control group had a median EFS of 25.9 months. The pathological complete response (pCR) rate was 17% in the Imfinzi group, compared to 4.3% in the placebo group, indicating a higher rate of complete tumor eradication at the time of surgery.
These findings are particularly significant given the high rates of recurrence and poor outcomes associated with NSCLC. The integration of Imfinzi into the perioperative treatment regimen offers a promising approach to improving long-term survival and reducing disease progression in these patients.
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Lung cancer remains a leading cause of cancer-related mortality globally. The CHMP's positive opinion suggests that incorporating Imfinzi into the perioperative treatment of NSCLC could become a new standard of care, offering patients a better chance at long-term survival.
AstraZeneca's Commitment
AstraZeneca continues to invest in research to improve outcomes for lung cancer patients. The AEGEAN trial is part of a broader effort to explore the potential of immunotherapies in various stages of lung cancer.
The CHMP's positive opinion is a critical step toward the formal approval of Imfinzi for this indication within the European Union. The European Commission will review this recommendation and make a final decision in the coming months. If approved, Imfinzi will become a new standard of care for patients with NSCLC, providing an immunotherapy option in both the neoadjuvant and adjuvant settings.
This development aligns with global trends in expanding the use of immunotherapy in early-stage lung cancer. In August 2024, the U.S. Food and Drug Administration (FDA) approved Imfinzi in combination with chemotherapy for neoadjuvant treatment, followed by adjuvant Imfinzi monotherapy, for patients with NSCLC without EGFR mutations or ALK rearrangements.
The CHMP's recommendation for Imfinzi's approval in the perioperative treatment of NSCLC represents a significant advancement in lung cancer therapy. Pending final approval by the European Commission, this regimen has the potential to become a new standard of care, offering hope for improved outcomes in patients facing this challenging disease.
