New long-term data from the Phase III FLAURA2 trial confirm that Tagrisso combined with chemotherapy delivers a significant overall survival benefit over monotherapy in patients with advanced EGFR-mutated non-small cell lung cancer.
AstraZeneca has shared final overall survival (OS) data of Tagrisso (osimertinib) in combination with pemetrexed and platinum-based chemotherapy from the Phase III FLAURA2 clinical trial (NCT04035486).1
According to the long-term follow up data from this most recent analysis, the Tagrisso regimen demonstrated a significant and clinically meaningful improvement in OS compared to Tagrisso alone for patients with 1st-line locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).
In a press release, Pasi A. Jänne, MD, PhD, senior vice president for translational medicine and thoracic medical oncologist at Dana-Farber Cancer Institute and principal investigator for the FLAURA2 trial, said: “When treating lung cancer, the aim is to both prolong survival and improve the patient experience, especially in 1st-line where treatment duration can be long and many patients remain active. These positive results support osimertinib, either as monotherapy or in combination with chemotherapy, as standard of care for patients with 1st-line advanced EGFR-mutated lung cancer and reinforce the meaningful benefit of the combination in the current clinical setting. The observed survival benefit is particularly impressive given that FLAURA2 did not impose any restrictions on the choice of subsequent treatment after disease progression.”
While AstraZeneca plans to present the full long-term results at an upcoming medical conference, the company reiterated that the final OS analysis builds on previously shared primary endpoint data, which demonstrated the longest-reported median progression-free survival (PFS) in this setting.
Even with longer follow up, the Tagrisso plus chemotherapy regimen’s safety remained manageable and consistent with the established profiles of the individual therapies. The rate of adverse events (AEs) was higher in the Tagrisso plus chemotherapy arm, driven by well-characterized chemotherapy-related AEs.
In the press release, Susan Galbraith, executive vice president, oncology hematology R&D, AstraZeneca, added: “These exciting overall survival results add to the extensive evidence supporting Tagrisso as the backbone therapy in EGFR-mutated lung cancer, demonstrating that Tagrisso plus chemotherapy can significantly extend survival in the 1st-line advanced setting, in addition to prior trials showing survival benefits as monotherapy in both early stage and advanced disease. With its strong survival benefit and tolerable safety profile, this combination has the potential to help patients live longer while maintaining their quality of life on treatment.”
In March 2024, AstraZeneca shared an earlier OS analysis of FLAURA2. Data from the time, at 41% maturity, showed:2
Earlier in February 2024, the FDA approved Tagrisso in combination with platinum-based chemotherapy in adults with locally advanced or metastatic EGFRm NSCLC harboring EGFR exon 19 deletions or exon 21 L858R mutations. The approval was based on primary endpoint data from FLAURA2, which demonstrated a significantly improved PFS at a median of 25.5 months compared with Tagrisso monotherapy at 16.7 months.3
1. TAGRISSO® (osimertinib) plus chemotherapy demonstrated statistically significant and clinically meaningful improvement in overall survival in EGFR-mutated advanced lung cancer. News release. AstraZeneca. July 21, 2025. Accessed July 23, 2025.
2. Results From FLAURA2 Phase III Trial Show Great Benefit from Tagrisso/Chemotherapy Combination in Lung Cancer Patients. Applied Clinical Trials. March 25, 2024. Accessed July 23, 2025.
3. FDA Approves Tagrisso for EGFR-Mutated Non-Small Cell Lung Cancer Based on Phase III FLAURA 2 Trial Data. Applied Clinical Trials. February 19, 2024. Accessed July 23, 2025.
