AstraZeneca has reported positive results from the Phase III ADAURA clinical trial of Tagrisso (osimertinib) in patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).

According to the data, the drug led to a statistically significant and clinically meaningful improvement in disease-free survival (DFS) when given as an adjuvant treatment to patients following complete tumour resection with curative intent.

Tagrisso decreased the risk of disease recurrence or death by 83%, with 89% of trial participants treated with the drug being alive and disease free at two years, compared to 53% on placebo.

ADAURA trial principal investigator Roy Herbst said: “These data are transformative for patients with early-stage EGFR-mutated non-small cell lung cancer who face high rates of recurrence even after successful surgery and subsequent treatment with adjuvant chemotherapy.

“Tagrisso will provide a much-needed new treatment option that has the potential to change the practice of medicine and improve outcomes for patients in this setting.”

In April this year, an Independent Data Monitoring Committee reviewed efficacy data from the trial and recommended unblinding two years early. The trial will be continued to track overall survival as a secondary endpoint.

The safety and tolerability of the drug was found to be consistent with prior trials in the metastatic setting. Grade 3 or higher adverse events from all causes were reported in 10% of patients in the study drug arm versus 3% in the placebo group.

AstraZeneca Oncology R&D executive vice-president José Baselga said: “The momentous results of the Phase III ADAURA trial for Tagrisso demonstrate for the first time in a global trial that an EGFR inhibitor can change the course of early-stage EGFR-mutated lung cancer and provide hope for a cure.

“We are discussing these outstanding data with regulatory authorities and look forward to bringing the benefits of Tagrisso to patients with early-stage disease.”

Tagrisso has approval as the first-line treatment of patients with locally advanced or metastatic EGFRm NSCLC in multiple countries.