FLAURA2 regimen achieves median OS of nearly 4 years in EGFR-mutated advanced NSCLC

22 Jan 2026
Kanas Chan
Kanas Chan
Kanas Chan
Kanas Chan
cupcake, candle with number 4, birthdaycupcake, candle with number 4, birthday

First-line osimertinib plus chemotherapy demonstrated a median overall survival (mOS) of nearly 4 years in patients with EGFR-mutated (exon 19 deletion or L858R mutation) advanced non-small-cell lung cancer (NSCLC) in the final OS analysis of the FLAURA 2 trial.

“On the basis of the prolonged progression-free survival and favourable benefit–risk profile observed in the primary analysis of the phase III FLAURA2 trial, clinical practice guidelines recommend osimertinib plus platinum–pemetrexed as a first-line treatment option for patients with EGFR-mutated advanced NSCLC,” wrote the authors of FLAURA 2. “Here, we report the results of the planned final analysis of OS, the key secondary endpoint of the trial.” [N Engl J Med 2026;394:27-38]

At the data cut-off on 12 June 2025 (overall data maturity, 57 percent), the 4-year OS rate was 49 percent in the osimertinib plus platinum–pemetrexed group vs 41 percent in the osimertinib monotherapy group.

An early intersection of Kaplan–Meier curves in favour of osimertinib plus platinum–pemetrexed was observed, starting at approximately 16 months, which was maintained until the data cut-off.

Of note, osimertinib plus platinum–pemetrexed showed a significantly longer mOS vs osimertinib monotherapy (47.5 vs 37.6 months; hazard ratio [HR], 0.77; 95 percent confidence interval [CI], 0.61–0.96; p=0.02).

“To put these further into context, these findings mean that almost half of the patients in the combination arm were alive at 4 years,” highlighted study investigator Dr David Planchard from the Department of Medical Oncology, Institut Gustave Roussy, Villejuif, France. “This represents the longest mOS in a global phase III study showing OS benefit in the advanced EGFR-mutated NSCLC population.” [Planchard D, et al, WCLC 2025, abstract PL02.06]

OS trends favouring osimertinib plus platinum–pemetrexed were consistently observed in the majority of preplanned subgroups, including:

  • Chinese patients (HR, 0.76; 95 percent, 0.48–1.20);
  • Presence of central nervous system (CNS) metastases at baseline (HR, 0.72; 95 percent CI, 0.52–0.99);
  • Absence of CNS metastases at baseline (HR. 0.77; 95 percent CI, 0.57–1.05);
  • Age <65 years (HR, 0.71; 95 percent, 0.53–0.95);
  • Age ≥65 years (HR, 0.87; 95 percent, 0.63–1.22);
  • Exon 19 deletion (HR, 0.76; 95 percent, 0.56–1.02);
  • L858R mutation (HR, 0.76; 95 percent, 0.55–1.07).

Grade ≥3 adverse events (AEs) of any cause were reported in 70 percent of patients in the osimertinib plus platinum–pemetrexed group vs 34 percent of patients in the osimertinib monotherapy group.

“Most high-grade toxic effects associated with the combination therapy were related to myelosuppressive effects, which are generally dose-related and reversible, with supportive interventions available for amelioration,” pointed out the investigators.

“The fundamental goals of lung cancer treatment are to extend survival and preserve patients’ quality of life,” said Planchard. “These compelling results of FLAUR2, which demonstrated unprecedented mOS, show that this combination can achieve both of these goals and support osimertinib, with or without the addition of chemotherapy, as the first-line standard of care for patients with EGFR-mutated advanced NSCLC.”

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