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Osimertinib Plus Chemotherapy Provides Broad Survival Benefit in EGFR-Mutant NSCLC

Key Clinical Takeaways

  • Design/Population: The phase 3 FLAURA2 trial evaluated osimertinib plus platinum–pemetrexed chemotherapy versus osimertinib alone in patients with newly diagnosed, advanced EGFR-mutant NSCLC. This subgroup analysis focused on patients with poor clinical or molecular prognostic factors, including brain, liver, or bone metastases, EGFR L858R mutations, exon 19 deletions, TP53 co-mutations, and detectable circulating tumor DNA.
  • Key Outcomes: Across all evaluated subgroups, the addition of chemotherapy to osimertinib improved overall survival compared with osimertinib monotherapy. Benefit was consistent regardless of baseline metastatic burden or molecular co-alterations, demonstrating superiority of the combination in both clinically and genomically high-risk populations.
  • Clinical Relevance: These results support osimertinib plus platinum–pemetrexed as an effective frontline option for a wide spectrum of EGFR-mutant NSCLC patients, including those traditionally considered poor responders to targeted therapy alone. Findings reinforce the role of combination therapy as a robust standard-of-care strategy in high-risk disease.


Pasi Jänne, MD, PhD, Dana-Farber Cancer Institute, Boston, Massachusetts, discusses subgroup analysis results from the FLAURA2 trial evaluating osimertinib plus platinum-pemetrexed chemotherapy versus osimertinib alone in patients with newly diagnosed EGFR-mutant non-small cell lung cancer (NSCLC). 

Results showed that the addition of chemotherapy consistently improved overall survival (OS) regardless of baseline metastatic burden or molecular co-alterations, demonstrating the superiority of the combination in both clinically and genomically high-risk populations. 

These findings were presented at the 2025 European Society for Medical Oncology (ESMO) Congress in Berlin, Germany.


Source: 

Janne P, Planchard D, Kobayashi K, et al. FLAURA2: Exploratory overall survival (OS) analysis in patients (pts) with poorer prognostic factors treated with osimertinib (osi) ± platinum-pemetrexed chemotherapy (CTx) as first-line (1L) treatment (tx) for EGFR-mutated (EGFRm) advanced NSCLC. Presented at the 2025 ESMO Congress. October 17-21, 2025; Berlin, Germany. LBA77 

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