ADAURA Update: Adjuvant Tagrisso Cuts Death Risk 48% at Eight Years in Resected EGFR-Mutated NSCLC
核心洞察
Updated ADAURA Phase III results show adjuvant Tagrisso (osimertinib) reduced the risk of death by 48% versus placebo at eight years in resected EGFR (搜索)-mutated NSCLC.
In the Stage II-IIIA primary population, 74% of Tagrisso-treated patients were alive at eight years versus 58% on placebo, with a hazard ratio of 0.53.
AstraZeneca described the findings as the longest survival data ever reported in a global Phase III trial in this early-stage lung cancer setting.
Adjuvant Tagrisso (osimertinib) sustained an overall survival benefit at eight years in patients with early-stage EGFR (搜索)-mutated non-small cell lung cancer (搜索) (NSCLC) after complete tumour resection with curative intent, reducing the risk of death by 48% versus placebo in the overall trial population, AstraZeneca reported on 14 September 2026.
The updated exploratory results from the ADAURA Phase III trial were presented during the Presidential Symposium at the IASLC 2026 World Conference on Lung Cancer in Seoul, Republic of Korea, and simultaneously published in the Journal of Thoracic Oncology as Abstract PL03.01, titled "Adjuvant Osimertinib in Resected EGFR (搜索)-Mutated Stage IB–IIIA Non-Small Cell Lung Cancer (搜索): Exploratory 8-year Overall Survival Landmark Update from the ADAURA Trial."
Eight-Year Survival Outcomes
In the primary population of patients with Stage II-IIIA disease, Tagrisso reduced the risk of death by 47% compared with placebo, based on a hazard ratio (HR) of 0.53 and a 95% confidence interval (CI) of 0.38-0.75. An estimated 74% of patients treated with Tagrisso were alive at eight years versus 58% of those treated with placebo, with median follow-up of 92 months and 68.5 months across 233 and 237 patients, respectively.
In the overall population (Stages IB-IIIA), an estimated 79% of Tagrisso-treated patients were alive at eight years versus 64% on placebo, with median follow-up of 93.3 months versus 79.6 months across 339 and 343 patients. AstraZeneca stated that the overall survival benefit was observed across all predefined subgroups, consistent with the planned final analysis, and described the findings as the longest survival data ever reported in a global Phase III trial in this setting.
The updated analysis had a data cut-off date of 4 May 2026 and was conducted in all randomised patients, incorporating complete or partial extended long-term survival data from approximately 77% of patients still alive at the final planned overall survival analysis cut-off, drawn from additional trial data or accessible medical records and last-contact information. The company stated that 127 patients had no additional survival data and remained censored, with survival time unchanged from the planned final analysis.
Investigator and Company Perspective
Roy S. Herbst, MD, PhD, Director at Dartmouth Cancer Center and principal investigator in the trial, said the findings show patients continue to experience long-term benefit from early intervention with adjuvant osimertinib, with "a 16 per cent point improvement in overall survival at eight years versus placebo." He noted high rates of crossover to osimertinib following disease recurrence and said the durable benefit reinforces the importance of prioritising EGFR (搜索) testing at diagnosis.
Susan Galbraith, Executive Vice President, Oncology Haematology R&D at AstraZeneca, said nearly 80 per cent of patients treated with adjuvant Tagrisso were alive at eight years and that the results "reinforce Tagrisso as the adjuvant standard of care and backbone therapy across stages of the disease."
Safety and Additional Analyses
Final safety data for ADAURA, collected at the planned final overall survival analysis, were consistent with Tagrisso's established profile, with no new safety concerns, according to the company.
Separately at the conference, a retrospective real-world cohort study of US patients with early-stage (I-IIIA) EGFR (搜索)-mutated NSCLC (Abstract P1.142) showed that early discontinuation of Tagrisso before completion of the three-year treatment course more than doubled the risk of disease recurrence or death.
In the advanced-disease setting, a FLAURA2 Phase III safety analysis (Abstract PT2.03.03) with median follow-up of 42.6 months showed the safety and tolerability of Tagrisso plus platinum-pemetrexed chemotherapy remained consistent with the established profiles of these medicines, with clear reductions in new adverse event onset following the initial induction period. An exploratory FLAURA2 analysis (Abstract P2.237) showed progression-free survival and overall survival hazard ratios numerically favoured the combination over Tagrisso monotherapy regardless of baseline TP53 (搜索) co-mutation status.
Trial Design and Drug Profile
ADAURA was a randomised, double-blind, placebo-controlled global Phase III trial in 682 patients with Stage IB, II and IIIA EGFR (搜索)-mutated NSCLC following complete tumour resection and, at physicians' and patients' discretion, adjuvant chemotherapy. Patients received Tagrisso 80 mg once-daily oral tablets or placebo for three years or until disease recurrence. The trial enrolled at more than 200 centres across more than 20 countries, including the US, Europe, South America, Asia and the Middle East. The primary endpoint was disease-free survival in Stage II-IIIA patients, with key secondary endpoints including disease-free survival in Stage IB-IIIA patients and overall survival in both the primary and overall populations.
Tagrisso is a third-generation, irreversible EGFR (搜索) tyrosine kinase inhibitor. AstraZeneca stated the medicine has been used to treat more than one million patients across its indications worldwide and is approved as monotherapy in more than 120 countries, including the US, EU, China and Japan, for first-line treatment of locally advanced or metastatic EGFR-mutated NSCLC, T790M mutation-positive NSCLC, adjuvant treatment of early-stage disease, and locally advanced unresectable NSCLC following platinum-based chemoradiation. It is also approved in combination with chemotherapy in more than 80 countries for first-line treatment of locally advanced or metastatic disease.
Beyond ADAURA, the company reported improved outcomes in the NeoADAURA and LAURA Phase III trials and is investigating Tagrisso in the ADAURA2, SAFFRON (with Orpathys/savolitinib), TROPION-Lung14 and TROPION-Lung15 (with Datroway) trials.
Disease Burden
According to background information in the company's announcement, lung cancer accounts for almost one in five (19%) cancer deaths globally, 80-85% of lung cancer patients are diagnosed with NSCLC, and approximately 25-30% present with resectable disease at diagnosis. Five-year survival stands at 73% for Stage IB, 56-65% for Stage II and 41% for Stage IIIA disease, and approximately 10-15% of NSCLC patients in the US and Europe and 30-40% of patients in Asia have EGFR (搜索)-mutated NSCLC.