Friday, the FDA approved AstraZeneca Plc's (NASDAQ:AZN) Imfinzi (durvalumab) in combination with chemotherapy for adult patients with resectable early-stage non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements.

In this regimen, patients are treated with Imfinzi in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery.

The FDA approval was based on the pivotal AEGEAN trial results published in The New England Journal of Medicine in October 2023.

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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.

In 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.

Imfinzi was generally well tolerated, and no new safety signals were observed in the neoadjuvant and adjuvant settings.

Imfinzi has also been 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.

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 3 trial.

Thursday, the FDA accepted and granted Priority Review for a supplemental marketing application seeking approval for Imfinzi limited-stage small cell lung cancer whose disease has not progressed following platinum-based concurrent chemoradiotherapy.

The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is anticipated during the fourth quarter of 2024.

The application is based on data from the ADRIATIC Phase 3 trial.

In the trial, Imfinzi reduced the risk of death by 27% compared to placebo (based on an overall survival [OS] hazard ratio [HR] of 0.73).

The estimated median OS was 55.9 months for Imfinzi versus 33.4 months for placebo.

An estimated 57% of patients treated with Imfinzi were alive at three years compared to 48% on placebo.

Imfinzi also reduced the risk of disease progression or death by 24% (based on progression-free survival [PFS] HR of 0.76) versus placebo. Median PFS was 16.6 months for Imfinzi versus 9.2 months for placebo.

An estimated 46% of patients treated with Imfinzi had not experienced disease progression at two years compared to 34% on placebo.

Price Action: AZN stock is up 0.33% at $85.18 during the premarket session at the last check on Friday.

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