FDA Approves AstraZeneca's Blockbuster Cancer Drug Imfinzi For Aggressive Form Of Lung Cancer

On Thursday, the FDA approved AstraZeneca Plc's AZN Imfinzi (durvalumab) for adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.

SCLC is a highly aggressive form of lung cancer.

The FDA approval was based on results from the ADRIATIC Phase 3 trial, presented during the Plenary Session of the 2024 American Society of Clinical Oncology Annual Meeting. It was subsequently published in the New England Journal of Medicine.

In the trial, Imfinzi reduced the risk of death by 27% versus placebo. The estimated median overall survival 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% for placebo.

Imfinzi also reduced the risk of disease progression or death by 24% versus placebo. The median progression-free survival (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% for placebo.

Based on the ADRIATIC results, Imfinzi has also been approved in Switzerland in this setting.

In August, the FDA approved 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.

Earlier this year, topline data from the ADJUVANT BR.31 Phase 3 trial showed that Imfinzi did not achieve statistical significance for the primary endpoint of disease-free survival versus placebo in early-stage NSCLC after complete tumor resection in patients whose tumors express PD-L1 on 25% or more tumor cells.

AstraZeneca also shared high-level results from the NIAGARA Phase 3 trial showing Imfinzi in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of event-free survival and the key secondary endpoint of overall survival versus neoadjuvant chemotherapy for muscle-invasive bladder cancer.

Price Action: At last check Thursday, AZN stock was up 1.31% at $67.66.

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