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Imfinzi Approved in the US for Pre- and Post-Surgery Treatment of Resectable Non-Small Cell Lung Cancer

NextEdge Admin

16 Aug 2024

2 min 44 sec

AstraZeneca’s Imfinzi (durvalumab) has received FDA approval in the US for treating adult patients with resectable early-stage (IIA-IIIB) non-small cell lung cancer (NSCLC) who do not have EGFR mutations or ALK rearrangements. This approval is based on positive results from the pivotal AEGEAN trial, published in The New England Journal of Medicine in October 2023.

The AEGEAN trial demonstrated that Imfinzi, when combined with neoadjuvant chemotherapy before surgery and used as adjuvant monotherapy after surgery, significantly improves patient outcomes. Specifically, the trial showed a 32% reduction in the risk of recurrence, progression, or death compared to chemotherapy alone, with an event-free survival (EFS) hazard ratio of 0.68. Additionally, the combination therapy achieved a pathologic complete response (pCR) rate of 17.2%, compared to 4.3% for chemotherapy alone.

Globally, lung cancer affects an estimated 2.4 million people annually, with about 235,000 new cases expected in the US in 2024. While 25-30% of NSCLC patients are diagnosed early enough for surgery with curative intent, many still face high recurrence rates. The survival rate for Stage II disease is 36-46%, dropping to 24% for Stage IIIA and 9% for Stage IIIB.

Dr. John V. Heymach of MD Anderson Cancer Center highlighted that this approval provides a crucial new treatment option for patients with resectable NSCLC, offering meaningful improvements in outcomes. AstraZeneca’s Oncology Business Unit Executive Vice President, Dave Fredrickson, emphasized the significance of this approval in early lung cancer settings, reinforcing Imfinzi’s role in changing clinical practice.

Imfinzi was well tolerated, with no new safety signals observed, and is also approved in the UK, Switzerland, and Taiwan. Regulatory reviews are ongoing in the EU, China, and other countries.