Biopharmaceutical company AstraZeneca PLC (LSE: AZN) (STO: AZN) (Nasdaq: AZN) announced on Monday that it has received a positive recommendation from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for the approval of Imfinzi (durvalumab) as part of a perioperative treatment regimen for adults with resectable non-small cell lung cancer (NSCLC). This approval recommendation is based on the promising results from the AEGEAN Phase III trial, which demonstrated that Imfinzi in combination with chemotherapy reduced the risk of recurrence, progression, or death by 32% compared to chemotherapy alone.

The AEGEAN trial, which published its findings in The New England Journal of Medicine, showed a statistically significant reduction in event-free survival (EFS) for patients receiving the Imfinzi-based regimen, with an EFS hazard ratio of 0.68 (95% CI 0.53-0.88; p=0.003902). In addition, patients treated with Imfinzi showed a 13% higher pathologic complete response (pCR) rate compared to chemotherapy alone (17.2% vs. 4.3%).

While interim overall survival (OS) results showed a favorable trend, final OS data will be further assessed as a key secondary endpoint in the trial. Imfinzi was well tolerated and did not introduce new safety concerns. The combination therapy did not compromise patients' ability to undergo surgery, a critical consideration for resectable NSCLC treatment.

Lung cancer, the leading cause of cancer-related deaths in Europe, presents a significant unmet need, particularly for patients with resectable disease who often face recurrence. AstraZeneca's treatment, if approved, offers a potential breakthrough for these high-risk patients.

Imfinzi is already approved in several countries, including the US, for similar indications, and regulatory applications are ongoing in other regions, including China and Japan. This recommendation is part of AstraZeneca's broader commitment to improving outcomes for lung cancer patients, aligning with the company's strategy to pioneer advancements in oncology.