WILMINGTON, DE — AstraZeneca’s (NYSE: AZN) Tagrisso showed a sustained survival benefit eight years after treatment in a Phase III trial of patients with early-stage EGFR-mutated non-small cell lung cancer, extending evidence for the drug’s use after tumors are surgically removed.
Updated exploratory results from the ADAURA trial showed Tagrisso, or osimertinib, reduced the risk of death by 47% compared with placebo among patients with Stage II to IIIA disease, the trial’s primary population. The hazard ratio was 0.53, with a 95% confidence interval of 0.38 to 0.75.
An estimated 74% of Tagrisso-treated patients in that group were alive at eight years, compared with 58% of patients who received placebo.
Across the broader trial population, which included Stage IB through IIIA disease, Tagrisso reduced the risk of death by 48%, with a hazard ratio of 0.52 and 95% confidence interval of 0.39 to 0.71. Estimated eight-year survival was 79% with Tagrisso and 64% with placebo.
The findings were presented at the International Association for the Study of Lung Cancer’s 2026 World Conference on Lung Cancer in Seoul and simultaneously published in the Journal of Thoracic Oncology. AstraZeneca described the follow-up as the longest survival data reported from a global Phase III trial in this treatment setting.
The trial evaluated adjuvant Tagrisso in patients with epidermal growth factor receptor-mutated, or EGFRm, non-small cell lung cancer after complete tumor resection with curative intent. AstraZeneca said the overall survival benefit was observed across all predefined subgroups, consistent with the trial’s planned final analysis.
Roy S. Herbst, director of Dartmouth Cancer Center and principal investigator for ADAURA, said the results showed a durable benefit despite patients crossing over to osimertinib after their cancer returned.
“These ADAURA findings show patients continue to experience meaningful, long-term benefit following early intervention with adjuvant osimertinib, with a 16 percent point improvement in overall survival at eight years versus placebo,” Herbst said.
Final safety data were collected during the planned final overall survival analysis. AstraZeneca said Tagrisso’s safety and tolerability remained consistent with its established profile, with no new safety concerns identified.
Separate real-world evidence presented at the conference examined U.S. patients with Stage I to IIIA EGFRm non-small cell lung cancer. In that retrospective cohort, discontinuing Tagrisso before completing the three-year treatment course was associated with more than twice the risk of disease recurrence or death.
AstraZeneca also presented longer-term findings from its FLAURA2 Phase III trial in first-line advanced EGFRm non-small cell lung cancer.
After a median 42.6 months of follow-up, the safety and tolerability of Tagrisso combined with platinum-pemetrexed chemotherapy remained consistent with the established safety profiles of the treatments, while the onset of new adverse events declined following the initial induction period.
An exploratory FLAURA2 analysis also found that progression-free and overall survival hazard ratios numerically favored Tagrisso plus platinum-pemetrexed over Tagrisso alone regardless of patients’ baseline TP53 co-mutation status.
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