Osimertinib Plus Chemotherapy as First-Line Standard-of-Care for Advanced EGFR-Mutant Non-Small Cell Lung Cancer
According to the final overall survival analysis of the phase 3 FLAURA2 study, osimertinib plus chemotherapy showed a statistically significant and clinically meaningful improvement to overall survival (OS) among untreated patients with EGFR-mutant advanced non-small cell lung cancer (NSCLC), when compared to osimertinib monotherapy.
These data were first presented by David Planchard, MD, PhD, Gustave Roussy Institute, Villejuif, France, at the International Association for the Study of Lung Cancer (IASLC) 2025 World Conference on Lung Cancer (WCLC) in Barcelona, Spain.
The global, open-label phase 3 FLAURA trial enrolled 556 patients with previously untreated EGFR-mutant locally advanced or metastatic NSCLC. Patients were randomized on a 1-to-1 basis to receive either osimertinib as monotherapy (n = 278) or in combination with chemotherapy (n = 279). The primary end point was progression-free survival (PFS) with OS as a key secondary end point. As previously reported, osimertinib plus chemotherapy improved PFS in this trial, leading to the approval of this regimen for this patient population.
The median OS in the monotherapy arm was 37.6 months compared with 47.5 months in the osimertinib plus chemotherapy arm (hazard ratio [HR], 0.77; P = .0202). At 36 months, the OS rates were 51% vs 63% respectively. This benefit was seen across all prespecified subgroups. There were no new safety signals observed, and the safety and tolerability continued to be tolerable, with no new treatment-related deaths in the osimertinib plus chemotherapy arm (1 new death in the monotherapy arm).
Dr Planchard et al concluded these data support osimertinib as the backbone treatment in this setting.” They went on that these data “confirm that osimertinib-plus-chemotherapy should be a first-line standard-of-care treatment in EGFR[-mutant] advanced NSCLC.”
Source:
Planchard D, Janne PA, Kobayashi K, et al. First-line osimertinib + chemotherapy versus osimertinib monotherapy in EGFRm advanced NSCLC: FLAURA2 final overall survival. Presented at the IASLC 2025 WCLC. September 6-9, 2025; Barcelona, Spain. Abstract PL02.06
