Final overall survival (OS) data from the FLAURA2 Phase III trial show a significant improvement in OS for patients receiving AstraZeneca’s TAGRISSO (osimertinib) plus chemotherapy compared to TAGRISSO monotherapy. The study involved patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).
The combination therapy resulted in a median OS of nearly four years (47.5 months), significantly longer than the approximately three years (37.6 months) observed with TAGRISSO alone. This represents a 23% reduction in the risk of death.
The findings, presented at the IASLC 2025 World Conference on Lung Cancer (WCLC) in Barcelona, Spain, were consistent across various patient subgroups. The control group received standard-of-care chemotherapy upon disease progression, validating the OS results.
Dr. David Planchard, principal investigator of the trial and thoracic oncologist at the Gustave Roussy Institute of Oncology in Villejuif, France, highlighted the combination’s ability to extend survival while maintaining quality of life. He emphasized the results support osimertinib, with or without chemotherapy, as a standard of care for first-line treatment of advanced EGFRm lung cancer.
Susan Galbraith, AstraZeneca’s Executive Vice President of Oncology Haematology R&D, stated that the FLAURA2 results establish a new survival standard. The nearly four-year median OS surpasses the three-year benchmark set by the original FLAURA trial. She noted TAGRISSO’s consistent strong survival benefits and acceptable safety profile across NSCLC stages, solidifying its position as a cornerstone therapy.
The safety profile of TAGRISSO plus chemotherapy remained manageable, consistent with the known profiles of the individual treatments. Grade 3 or higher adverse events occurred in 70% of patients in the combination arm, primarily due to chemotherapy-related effects, compared to 34% in the monotherapy arm. Treatment discontinuation due to adverse events remained low in both groups.
TAGRISSO carries important safety information. It can cause serious and potentially fatal interstitial lung disease (ILD)/pneumonitis, heart rate-corrected QT (QTc) interval prolongation, and cardiomyopathy. Regular monitoring is necessary for patients receiving TAGRISSO, particularly those with pre-existing cardiac risk factors. Other potential side effects include keratitis, and rare occurrences of erythema multiforme major (EMM), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), cutaneous vasculitis, and aplastic anemia. Appropriate precautions and monitoring are crucial.
The FLAURA2 trial enrolled over 557 patients across numerous global centers. The primary endpoint was progression-free survival, with OS as a key secondary endpoint. The study’s design and results further establish TAGRISSO’s role in treating EGFRm NSCLC.
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