Biopharma

AstraZeneca’s Tagrisso delivers strong phase 3 results in early stage lung cancer

Updated exploratory results from the Phase 3 ADAURA trial showed that Tagrisso reduced the risk of death by 47% compared with placebo in the primary population of patients with Stage II-IIIA disease

  • By IPP Bureau | September 14, 2026

AstraZeneca’s Tagrisso (osimertinib) has demonstrated a sustained overall survival benefit at eight years in patients with early-stage EGFR-mutated non-small cell lung cancer (NSCLC), reinforcing its role as a standard of care following complete tumour resection.

Updated exploratory results from the Phase 3 ADAURA trial, presented at the IASLC 2026 World Conference on Lung Cancer in Seoul, showed that Tagrisso reduced the risk of death by 47% compared with placebo in the primary population of patients with Stage II-IIIA disease. 

The overall survival hazard ratio was 0.53 (95% CI 0.38-0.75).

At 96 months, an estimated 74% of patients receiving Tagrisso remained alive, compared with 58% of those receiving placebo.

In the overall trial population comprising patients with Stage IB-IIIA disease, Tagrisso reduced the risk of death by 48%, with an OS hazard ratio of 0.52 (95% CI 0.39-0.71). The estimated eight-year survival rate was 79% with Tagrisso versus 64% with placebo.

The updated analysis had a data cut-off of May 4, 2026, with median follow-up of 92 months in the primary population and 93.3 months in the overall population.

“These ADAURA findings show patients continue to experience meaningful, long-term benefit following early intervention with adjuvant osimertinib, with a 16 per cent point improvement in overall survival at eight years versus placebo,” said Roy S. Herbst, Director, Dartmouth Cancer Center, and principal investigator of the ADAURA trial.

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said the findings reinforce Tagrisso as the adjuvant standard of care and backbone therapy across stages of EGFR-mutated lung cancer.

The ADAURA findings were simultaneously published in the Journal of Thoracic Oncology.

Real-world evidence presented at WCLC 2026 also highlighted the importance of treatment persistence. A retrospective US study of patients with Stage I-IIIA EGFR-mutated NSCLC found that early discontinuation of Tagrisso before completing the three-year treatment course more than doubled the risk of disease recurrence or death.

Meanwhile, data from the FLAURA2 Phase 3 trial in advanced EGFR-mutated NSCLC continued to support Tagrisso in combination with platinum-pemetrexed chemotherapy as a first-line treatment option. 

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