Clinical Trial Finds Osimertinib Combined with Chemotherapy Extends Survival in EGFR-Mutated Advanced Lung Cancer

A recent Phase III clinical trial, known as FLAURA2, has demonstrated that combining osimertinib with chemotherapy significantly improves overall survival in patients with EGFR-mutated advanced non-small cell lung cancer (NSCLC). The trial's final results reveal that this combination therapy offers a substantial survival benefit over osimertinib alone.

The FLAURA2 study involved 557 patients who had not received prior treatment for their condition and had confirmed EGFR mutations. Participants were randomized in a 1:1 ratio to receive either osimertinib with chemotherapy—comprising pemetrexed along with cisplatin or carboplatin—or osimertinib alone. The primary goal was to assess progression-free survival, with overall survival as a key secondary endpoint.

With a median follow-up of approximately 57% maturity, the group receiving both osimertinib and chemotherapy showed a median overall survival of 47.5 months, significantly higher than the 37.6 months observed in the monotherapy group. The 36-month survival rate was 63% with the combination therapy compared to 51% with osimertinib alone. These results were consistent across various patient subgroups.

Safety profiles for the combination treatment remained manageable, with side effects aligning with the known safety profiles of the individual treatments. Notably, adverse events leading to discontinuation occurred in 12% of patients on the combination arm versus 7% on monotherapy.

These findings, presented at the IASLC 2025 World Conference on Lung Cancer, suggest that adding chemotherapy to osimertinib could establish a new standard of care for patients with EGFR-mutated advanced NSCLC. Dr. David Planchard from Institut Gustave Roussy emphasized that this combination extends survival while maintaining a manageable safety profile, reinforcing the role of osimertinib as the backbone of first-line therapy in this setting.

Osimertinib, a third-generation EGFR tyrosine kinase inhibitor, is currently preferred as a first-line treatment. The trial results support augmenting this therapy with chemotherapy for a significant overall survival advantage, potentially reshaping treatment guidelines for this patient population.

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