Combination of Osimertinib and Chemotherapy Enhances Survival in EGFR-Mutated Advanced Lung Cancer
The final results from the Phase III FLAURA2 trial indicate that the combination of osimertinib and chemotherapy significantly enhances overall survival rates in patients suffering from advanced non-small cell lung cancer (NSCLC) with EGFR mutations. This pivotal study was presented at the 2025 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer.
Osimertinib, a third-generation EGFR tyrosine kinase inhibitor known for its activity in the central nervous system, is already a standard first-line treatment for patients with EGFR-mutated advanced NSCLC. The FLAURA2 trial aimed to assess whether adding chemotherapy to osimertinib could improve patient outcomes further.
In this global, open-label, randomized study, 557 patients with untreated EGFR-mutated advanced NSCLC were enrolled. Participants were split into two groups: one receiving osimertinib combined with chemotherapy (specifically pemetrexed with either cisplatin or carboplatin), and the other receiving osimertinib alone. The primary endpoint of the trial was progression-free survival (PFS), with overall survival (OS) being a key secondary endpoint.
Results from the trial, following a median follow-up period that achieved approximately 57% maturity, showed a statistically significant improvement in overall survival for patients receiving the combination therapy. The hazard ratio was reported at 0.77, with a confidence interval of 0.61 to 0.96, yielding a p-value of 0.02. Specifically, the median overall survival for the combination group was 47.5 months, compared to 37.6 months for those on monotherapy. Additionally, the three-year survival rate was notably higher at 63% for the combination therapy versus 51% for the single-agent treatment.
The safety profile of the combined treatment was deemed manageable, aligning with previously known safety profiles of both osimertinib and chemotherapy. No new safety concerns emerged during the extended follow-up period. Adverse events resulting in the discontinuation of osimertinib were observed in 12% of patients receiving combination therapy, while 7% of patients in the monotherapy group experienced similar issues.
These findings affirm the role of osimertinib plus chemotherapy as a first-line standard of care for patients diagnosed with EGFR-mutated advanced NSCLC. The integration of chemotherapy with osimertinib has proven to extend survival for these patients while maintaining an acceptable safety profile.
The results of the FLAURA2 trial reinforce the position of osimertinib as the foundational treatment in this context, with the addition of chemotherapy offering a meaningful survival advantage for patients with advanced NSCLC characterized by EGFR mutations.