AstraZeneca's Imfinzi Gets US Approval For Resectable Early-stage Lung Cancer

(RTTNews) - British drug major AstraZeneca Plc (AZN.L, AZN) announced Friday that its Imfinzi (durvalumab) in combination with chemotherapy has been approved in the US for adult patients with resectable non-small cell lung cancer or NSCLC before and after surgery.

The approval by the U.S. Food and Drug Administration was based on positive results from the pivotal AEGEAN Phase III trial, which showed Imfinzi-based regimen reduced the risk of recurrence, progression or death by 32% vs. neoadjuvant chemotherapy alone.

The trial results were published in The New England Journal of Medicine in October 2023.

The drug has been approved for the treatment of adult patients with resectable early-stage or IIA-IIIB NSCLC and no known epidermal growth factor receptor or 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.

The company noted that 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.

In a final analysis of pathologic complete response or 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, the company noted. Imfinzi is also approved in the UK, Switzerland and Taiwan (China) in this setting based on the AEGEAN results. Regulatory applications are also currently under review in the EU, China and several other countries in this indication.

AstraZeneca added that Imfinzi is the only approved immunotherapy and the global standard of care in the curative-intent setting of unresectable, Stage III NSCLC in patients whose disease has not progressed after chemoradiotherapy based on the PACIFIC Phase III trial.

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