AstraZeneca's Imfinzi gets fresh approval in the US

The FTSE 100 pharmaceuticals giant said the approval was based on results from the phase thee AEGEAN trial, which showed that Imfinzi combined with chemotherapy before surgery and as a standalone treatment after surgery significantly reduced the risk of cancer recurrence, progression or death by 32% compared to chemotherapy alone.

It said the trial findings, which were published in the New England Journal of Medicine in October 2023, provided pivotal data that led to the FDA's decision.

The trial showed that patients receiving the Imfinzi-based regimen had a 32% reduction in event-free survival (EFS) risk, with a hazard ratio of 0.68, indicating a statistically significant improvement.

It also showed a pathologic complete response (pCR) rate of 17.2% in the Imfinzi group, compared to 4.3% in the chemotherapy-alone group.

AstraZeneca described lung cancer as a major global health issue, with 2.4 million new cases expected annually.

In the US alone, around 235,000 people are expected to be diagnosed in 2024.

Early-stage NSCLC, which affects 25% to 30% of those patients, often led to recurrence after surgery, underscoring the need for more effective treatments like Imfinzi.

The company said the safety profile of Imfinzi in the neoadjuvant and adjuvant settings was consistent with previous studies, and no new safety concerns were identified.

Imfinzi is already approved in the UK, Switzerland, and Taiwan for the same indication, with regulatory reviews underway in the European Union, China, and other countries.

The drug is also the global standard of care for unresectable stage three NSCLC following chemoradiotherapy, based on earlier findings from the PACIFIC trial.

“Today's approval of Imfinzi in resectable early-stage lung cancer builds on its strong foundation of changing clinical practice in unresectable stage three disease,” said Dave Fredrickson, executive vice-president of AstraZeneca’s oncology business unit.

“We remain committed to bringing novel approaches like AEGEAN to early lung cancer settings where cure is the goal of treatment.”

At 0819 BST, shares in AstraZeneca were down 0.03% at 13,162p.

Reporting by Josh White for Sharecast.com.