Early-stage lung cancer patients on Tagrisso are living past 8 years

Patients with resected, early-stage epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who took adjuvant Tagrisso (osimertinib) remained their survival eight years after starting treatment, according to updated results from the phase 3 ADAURA trial, which were also published in the Journal of Thoracic Oncology.

ADAURA is a randomized, double-blind, placebo-controlled trial that enrolled 682 patients with completely resected stage IB, II or IIIA EGFR-mutated NSCLC at more than 200 centers in over 20 countries. Patients received Tagrisso, AstraZeneca's third-generation EGFR tyrosine kinase (TK) inhibitor, or placebo once daily for three years or until their cancer returned. The FDA approved Tagrisso as adjuvant therapy for this population in 2020.

According to AstraZeneca, mutations in EGFR are found in an estimated 10% to 15% of NSCLC patients in the U.S.

What the 8-year ADAURA data revealed

At a median follow-up approaching eight years, results showed a sustained overall survival benefit favoring Tagrisso in both trial populations. Out of the patients with stage II-IIIA disease, the trial's primary population, the drug reduced the risk of death by 47% compared with placebo, with 74% of patients alive at eight years versus 58% on placebo, a 16-percentage point difference.

Across the full study population of stage IB-IIIA patients, Tagrisso reduced the risk of death by 48%, and 79% of treated patients were alive at eight years compared with 64% of those on placebo. The benefit was consistent across patient subgroups and disease stages. For example, 8-year survival rates with Tagrisso versus placebo were 91% compared to 77% for stage IB disease, 78% versus 63% for stage II and 70% compared to 52% for stage IIIA.

The findings come from an exploratory, post hoc analysis of survival data collected after the trial's planned final analysis in 2023, when 82% of patients were still alive. Researchers of this analysis noted the survival estimates may be conservative, as roughly a quarter of surviving patients failed to follow up beyond that point and remained censored at their last known contact date. This imbalance appeared more in the placebo portion of the analysis.

“These ADAURA findings show patients continue to experience meaningful, long-term benefit following early intervention with adjuvant osimertinib…,” Roy S. Herbst, M.D., Ph.D., principal investigator of the ADAURA trial and director of the Dartmouth Cancer Center, said in a news release. “This is especially impressive given high rates of crossover to osimertinib following disease recurrence. This durable overall survival benefit reinforces the importance of prioritizing EGFR testing at diagnosis so as many patients as possible can benefit from this transformative therapy."

Why treatment persistence matters for payers

The ADAURA update comes at a time where additional real-world data that could matter more directly to health plans managing adjuvant therapy is also being revealed. A separate retrospective cohort study of U.S. patients with early-stage EGFR-mutated NSCLC, recently presented at the 2026 World Conference of Lung Cancer, found that stopping Tagrisso before completing the full three-year course more than doubled the risk of recurrence or death, according to the release. AstraZeneca said the finding highlights the need for clinician-patient communication to support treatment persistence, a flag that adherence support across the full three-year regimen, not just initial access, could be critical to realizing the survival benefit that ADAURA notes.

Tagrisso is now approved as monotherapy in more than 120 countries, including the U.S., across earlier and more advanced stages of EGFR-mutated NSCLC. AstraZeneca said in the release, the company positions the drug as backbone therapy for the mutation regardless of when the disease is caught.

Additional data presented at the meeting from the phase 3 FLAURA2 trial reinforced Tagrisso's long-term safety profile when combined with chemotherapy in first-line advanced disease, with an exploratory analysis showing similar benefit regardless of patients' TP53 co-mutation status.

“ADAURA continues to set new benchmarks in early-stage EGFR-mutated lung cancer, with nearly 80% of patients treated with adjuvant Tagrisso alive at eight years,” Susan Galbraith, executive vice president of oncology hematology research and development at AstraZeneca, said in the release. “These results underscore the importance of treating early and reinforce Tagrisso as the adjuvant standard of care and backbone therapy across stages of the disease.”