AstraZeneca gets positive feedback on possible Imfinzi indication

The FTSE 100 pharmaceuticals giant said the trial showed that Imfinzi met the primary endpoint of event-free survival (EFS) and showcased a tolerable safety profile.

Patients in the trial had resectable early-stage NSCLC (IIA-IIIB) without EGFR mutations or ALK rearrangements and were treated with Imfinzi combined with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy post-surgery.

The FDA previously accepted the supplemental biologics licence application (sBLA) for Imfinzi in September last year, following positive results published in The New England Journal of Medicine.

Interim analysis from the trial indicated a significant 32% reduction in the risk of recurrence, progression, or death compared to chemotherapy alone, which was reflected in the EFS hazard ratio of 0.68.

Additionally, Imfinzi combined with neoadjuvant chemotherapy before surgery resulted in a pathologic complete response (pCR) rate of 17.2%, significantly higher than the 4.3% observed with chemotherapy alone.

Imfinzi was generally well tolerated, with no new safety concerns identified in both neoadjuvant and adjuvant settings.

The addition of Imfinzi to neoadjuvant chemotherapy did not compromise surgical outcomes compared to chemotherapy alone, maintaining consistency with the known safety profile of this combination.

AstraZeneca said the ODAC's acknowledgment would inform the FDA's review process, though the agency was not obliged to follow the committee's recommendations.

Imfinzi is already approved for treating resectable NSCLC in stage two and three in Switzerland and the UK based on the AEGEAN results, with regulatory reviews ongoing in the EU, China, and other countries.

Imfinzi remained the only approved immunotherapy and the global standard of care for unresectable stage three NSCLC in patients whose disease has not progressed following chemoradiotherapy.

“The committee's discussion of the AEGEAN data highlighted the significant benefit delivered by this Imfinzi-based regimen for patients with resectable lung cancer,” said executive vice-president of oncology research and development Susan Galbraith.

“We are committed to working closely with the FDA to bring this novel immunotherapy option to patients that offers a flexible chemotherapy backbone.”

At 0856 BST, shares in AstraZeneca were up 1.61% at 12,248p.

Reporting by Josh White for Sharecast.com.