FDA approves AstraZeneca's blockbuster cancer drug Imfinzi in combination with chemotherapy for non-small cell lung cancer

On Friday, the FDA approved AstraZeneca Plc's (NASDAQ:AZN) Imfinzi (durvalumab) in combination with chemotherapy for adult patients with early-stage resectable non-small cell lung cancer (NSCLC) and without known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements.

In this treatment 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 key results of the AEGEAN trial, published in the New England Journal of Medicine in October 2023.

Also read: AstraZeneca's blockbuster cancer drug Imfinzi fails follow-up study in early-stage lung cancer, but meets main goal in Phase 3 trial in bladder cancer.

Results from a planned interim analysis of event-free survival (EFS) demonstrated a statistically significant and clinically meaningful 32% reduction in the risk of relapse, progression events, or death compared with 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 pathological complete response (pCR), treatment with Imfinzi plus neoadjuvant chemotherapy before surgery resulted in a pCR rate of 17.2% versus 4.3% in patients treated with neoadjuvant chemotherapy alone.

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

Based on the AEGEAN results, Imfinzi was also approved in the UK, Switzerland and Taiwan (China) in this context.

Applications for approval for this indication are also currently being reviewed in the EU, China and several other countries.

Imfinzi is the only approved immunotherapy and the global standard of care with curative intent for unresectable stage III NSCLC who have not progressed after chemoradiotherapy in the PACIFIC Phase 3 trial.

On Thursday, the FDA accepted and granted priority review to a supplemental new drug application for Imfinzi to treat limited-stage small cell lung cancer whose disease has not progressed after concurrent platinum-based chemoradiotherapy.

The date for implementation of the Prescription Drug User Fee Act and thus the FDA’s regulatory decision is expected in the fourth quarter of 2024.

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

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

The story continues

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 after three years, compared with 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. The median PFS was 16.6 months for Imfinzi versus 9.2 months for placebo.

An estimated 46% of patients treated with Imfinzi had no disease progression after two years, compared with 34% on placebo.

Price promotion: At last check on Friday, AZN shares were up 0.33% to $85.18 in premarket trading.

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