EMA Recommends Imfinzi-Based Perioperative Regimen for Treating Resectable NSCLC
The committee’s recommendation is based on results from a Phase III trial in which Imfinzi demonstrated a reduced risk of recurrence, progression, or death by 32% compared to neoadjuvant chemotherapy alone.
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AstraZeneca announced on March 3, 2025 that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended for approval in the European Union (EU) the use of durvalumab (brand name Imfinzi) in combination with chemotherapy to treat adults with resectable non-small cell lung cancer (NSCLC). The treatment is aimed at those patients who are at high risk of recurrence and no epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. This regimen involves treating patients with durvalumab in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery (1).
The CHMP’s positive opinion is based on results from a Phase III trial (AEGEAN), which showed a statistically significant and clinically meaningful 32% reduction in the risk of recurrence, progression events, or death in patients treated with the regimen versus patients treated with neoadjuvant chemotherapy alone. Meanwhile, an interim analysis of overall survival showed a favorable trend with use of the regimen.
“Adding perioperative durvalumab to neoadjuvant chemotherapy significantly improved outcomes for patients with resectable non-small cell lung cancer, who experience high rates of recurrence and poor outcomes,” said Professor Martin Reck, head of the Department of Thoracic Oncology at the Lung Clinic Grosshansdorf, Germany, member of the AEGEAN Steering Committee and investigator in the trial, in an AstraZeneca press release (1). “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.”
More than 450,000 people are diagnosed with lung cancer in Europe annually (2), and, of the most common form of lung cancer, NSCLC, approximately 25–30% of NSCLC patients are diagnosed early enough to have surgery with curative intent (3,4). The majority of patients with resectable disease will, however, develop recurrence, and only 36–46% of patients who are at Stage II of the disease will survive for five years (5,6). That number decreases to 24% for patients in Stage IIIa of the disease and 9% for patients in Stage IIIb of the disease (5). Thus, there is high unmet medical need in this area.
urvalumab was shown to be generally well tolerated, and no new safety issues were observed in the neoadjuvant and adjuvant settings. Adding durvalumab to neoadjuvant chemotherapy was consistent with the known profile for this combination. Patients’ ability to complete surgery was not compromised on this regimen, compared to chemotherapy alone.
“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,” said Susan Galbraith, executive vice president, Oncology Hematology R&D, AstraZeneca, in the press release.
Durvalumab (under brand name Imfinzi) is approved in the United States and several other countries in the resectable NSCLC setting based on the same Phase III trial results. AstraZeneca also has regulatory applications currently under review in China, Japan, and additional countries.
References
1. AstraZeneca. Imfinzi-Based Perioperative Regimen Recommended for Approval in the EU by CHMP for Resectable Non-Small Cell Lung Cancer. Press Release. March 3, 2025.
2. Ferlay, J.; Colombet, M.; Soerjomataram, I.; et al. Cancer Incidence and Mortality Patterns in Europe: Estimates for 40 Countries and 25 Major Cancers in 2018. Eur. J. Cancer 2018, 103, 356–387. DOI: 10.1016/j.ejca.2018.07.005
3.Cagle, P. T.; Allen, T. C.; Olsen, R.J. Lung Cancer Biomarkers: Present Status and Future Developments. Arch. Pathol. Lab. Med. 2013, 137 (9), 1191–1198. DOI: 10.5858/arpa.2013-0319-CR
4. Le Chevalier T. Adjuvant Chemotherapy for Resectable Non-Small-Cell Lung Cancer: Where is it Going? Ann. Oncol. 2010, 21 (suppl 7), vii196–198. DOI: 10.1093/annonc/mdq376
5. Goldstraw, P.; Crowley, J.; Chansky, K.; et al. The IASLC Lung Cancer Staging Project: Proposals for the Revision of the TNM Stage Groupings in the Forthcoming (Seventh) Edition of the TNM Classification of Malignant Tumors. J. Thorac. Oncol. 2007, 2 (8), 706–714. DOI: 10.1097/JTO.0b013e31812f3c1a
6. Pignon, J. P.; Tribodet, H.; Scagliotti, G.V.; et al. Lung Adjuvant Cisplatin Evaluation: A Pooled Analysis by the LACE Collaborative Group. J. Clin. Oncol. 2008, 26 (21), 3552–3559.
