In advanced disease, data from FLAURA2 and LAURA reinforce TAGRISSO as a backbone therapy with favorable safety and tolerability over long-term follow-up.

The summary outlines trial design, patient population, endpoints (disease-free survival and overall survival), and the status of regulatory labeling across regions.

Real-world evidence from US early-stage EGFRm NSCLC patients shows stopping TAGRISSO early raises the risk of recurrence or death, underscoring the importance of completing a three-year course.

In the primary population (Stages II–IIIA), TAGRISSO reduces risk of death by 47% versus placebo, with 74% alive at eight years on TAGRISSO compared with 58% on placebo.

Across the overall population (Stages IB–IIIA), TAGRISSO reduces risk of death by 48% versus placebo, with 79% alive at eight years on TAGRISSO versus 64% on placebo.

Overall eight-year survival shows TAGRISSO at 79% vs 64% for placebo in the broader population.

Important safety notes include risks of ILD/pneumonitis, QTc prolongation, cardiomyopathy, keratitis, and other postmarketing signals, requiring ongoing monitoring.

-

The analysis uses a May 4, 2026 data cut-off with long-term follow-up from randomized patients; 127 patients were censored due to no new data.

ADAURA ongoing trials (including ADAURA2) and TAGRISSO’s approvals across multiple indications and combinations across stages provide broader context.

Safety data remained consistent with TAGRISSO’s established profile, with no new safety concerns at the final OS analysis.

TAGRISSO (osimertinib) demonstrated an eight-year overall survival benefit in the ADAURA Phase III trial for early-stage EGFR-mutated NSCLC after complete resection.