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Imfinzi approved in US for resectable lung cancer
Imfinzi approved in US for resectable lung cancer.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n\n16 August 2024 \n \nImfinzi approved in the US for the treatment of resectable\nnon-small cell lung cancer before and after surgery\nBased on AEGEAN Phase III trial results which showed Imfinzi-based regimen reduced the risk of recurrence, progression or death by 32% vs. neoadjuvant chemotherapy alone\n \nAstraZeneca's Imfinzi (durvalumab) in combination with chemotherapy has been approved in the US for the treatment of adult patients with resectable early-stage (IIA-IIIB) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. In this regimen, patients are treated with Imfinzi in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery. \n \nThe approval by the Food and Drug Administration (FDA) was based on positive results from the pivotal AEGEAN trial, which were published in The New England Journal of Medicine in October 2023. Results from a planned interim analysis of event-free survival (EFS) showed a statistically significant and clinically meaningful 32% reduction in the risk of recurrence, progression events or death versus chemotherapy alone in patients treated with the Imfinzi-based regimen before and after surgery (32% data maturity; EFS hazard ratio of 0.68; 95% confidence interval [CI] 0.53-0.88; p=0.003902).\n \nIn a final analysis of pathologic complete response (pCR), treatment with Imfinzi plus neoadjuvant chemotherapy before surgery resulted in a pCR rate of 17.2% versus 4.3% for patients treated with neoadjuvant chemotherapy alone (difference in pCR 13.0%; 95% CI 8.7-17.6).\n \nEach year, there are an estimated 2.4 million people diagnosed with lung cancer globally, with approximately 235,000 new diagnoses expected in the US in 2024.1-2 Around 25-30% of all patients with NSCLC, the most common form of lung cancer, are diagnosed early enough to have surgery with curative intent.3-4 However, the majority of patients with resectable disease will develop recurrence and only 36-46% of patients with Stage II disease will survive for five years.5-6 This decreases to 24% for patients with Stage IIIA disease and 9% for patients with Stage IIIB disease, reflecting a high unmet medical need.6\n \nJohn V. Heymach, MD, PhD, Professor and Chair ...