AstraZeneca’s Tagrisso (osimertinib), in combination with pemetrexed and platinum-based chemotherapy, has shown a significant improvement in overall survival (OS) in the final OS analysis of the randomised FLAURA2 Phase III trial for non-small cell lung cancer (NSCLC).
This improvement was observed when the combination was evaluated against Tagrisso as a single agent in the first-line treatment of individuals with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) NSCLC.
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Progression-free survival (PFS) is the primary endpoint of the trial while the secondary endpoint is OS.
The global, open-label, multi-centre study involved 557 subjects across more than 150 centres in over 20 countries.
It focused on those who had not previously undergone treatment for locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) NSCLC, specifically those whose tumours exhibited EGFR exon 19 deletions or exon 21 L858R mutations.
Participants in the trial received an oral dosage of 80mg of Tagrisso daily, in conjunction with a chemotherapy regimen.
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By GlobalDataThe median OS demonstrated by the combination therapy was approximately four years, surpassing the nearly three-year median OS for patients treated with Tagrisso alone.
At 57% data maturity, the mortality risk was decreased by 23% for patients receiving the combination therapy, compared to those receiving monotherapy.
Three years after treatment, 63.1% of subjects in the combination group were still alive. At four years, the figure was 49.1%.
This compares to the 50.9% and 40.8% survival rates at the same time points in the standalone therapy group.
AstraZeneca noted that the OS benefit was found to be consistent across all prespecified subgroups.
The safety profile of the Tagrisso and chemotherapy combination remained consistent and manageable over longer follow-up periods, aligning with the known profiles of the individual medicines.
AstraZeneca oncology haematology research and development executive vice-president Susan Galbraith said: “The latest FLAURA2 trial results set a new survival standard for patients, with Tagrisso plus chemotherapy demonstrating a median overall survival of nearly four years in first-line advanced EGFR-mutated lung cancer, surpassing the three-year benchmark established in the FLAURA trial.”
The irreversible third-generation EGFR-tyrosine kinase inhibitor (TKI), Tagrisso, gained approval as a single-use agent in over 120 locations, including the European Union (EU), Japan, China, and the US.
In 2023, AstraZeneca reported positive outcomes from the ADAURA Phase III trial of Tagrisso in the adjuvant treatment of individuals with Stage IB, II, and IIIA EGFRm NSCLC.
