WILMINGTON, DE — AstraZeneca announced that its lung cancer therapy TAGRISSO® (osimertinib), when used in combination with chemotherapy, delivered a statistically significant and clinically meaningful improvement in overall survival for patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC). The findings are from the final analysis of the FLAURA2 Phase III trial.
The combination of TAGRISSO with pemetrexed and platinum-based chemotherapy outperformed TAGRISSO monotherapy in prolonging life for patients in the first-line treatment setting. These final results confirm earlier interim data and build upon previous outcomes showing record progression-free survival in this patient population.
Pasi A. Jänne, MD, PhD, principal investigator of the FLAURA2 trial, emphasized the importance of balancing survival with quality of life. “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,” he said.
Susan Galbraith, AstraZeneca’s Executive Vice President for Oncology R&D, added that the trial results reinforce TAGRISSO’s central role in the treatment of EGFR-mutated lung cancer. “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,” Galbraith stated.
Broad Impact in a High-Need Area
Lung cancer remains the leading cause of cancer-related deaths globally. Non-small cell lung cancer accounts for 80–85% of cases, and a substantial portion of those are driven by EGFR mutations. These patients often respond to EGFR-targeted therapies, but resistance and disease progression remain major hurdles.
TAGRISSO is a third-generation EGFR tyrosine kinase inhibitor (TKI) already approved in over 120 countries for multiple indications, including early-stage and advanced EGFRm NSCLC. It has been used to treat more than one million patients worldwide.
The FLAURA2 trial enrolled 557 patients across more than 150 sites in over 20 countries. The regimen combined daily TAGRISSO with chemotherapy for four cycles, followed by maintenance therapy. The study’s primary goal was progression-free survival; overall survival was a key secondary measure.
Manageable Safety Profile
While combining TAGRISSO with chemotherapy led to higher rates of adverse events, these were consistent with known chemotherapy-related effects. Importantly, the rate of treatment discontinuation due to adverse events remained low across both treatment groups.
Regulatory Path and Future Outlook
The survival data will be presented at an upcoming medical conference and submitted to regulatory authorities worldwide. TAGRISSO combined with chemotherapy is already approved in more than 80 countries for first-line treatment of EGFRm NSCLC, including the U.S., Europe, China, and Japan.
This latest data further solidifies TAGRISSO’s position as a cornerstone therapy in lung cancer care. AstraZeneca is continuing to investigate the drug in multiple stages of disease, including in early-stage settings through ongoing trials such as ADAURA2.
The results of FLAURA2 mark another milestone in the evolving standard of care for patients with EGFR-mutated NSCLC, offering new hope for improved survival outcomes in one of the deadliest forms of cancer.
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