Limertinib for EGFR mutation-positive NSCLC treatment
Mené sur 337 patients atteints d'un cancer du poumon non à petites cellules avec mutation EGFR (délétion de l'exon 19 ou mutation de l'exon 21 L858R) et de stade localement avancé ou métastatique (âge médian : 63 ans), cet essai randomisé de phase III compare l'efficacité, du point de vue de la survie sans progression, et la toxicité de 2 traitements de première ligne, l'un par géfitinib et l'autre par limertinib (un inhibiteur d'EGFR de troisième génération)
In the Lancet Respiratory Medicine, Shi and colleagues report the results of a randomised, phase 3 trial comparing limertinib, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), with gefitinib, as a first-line treatment for locally advanced or metastatic EGFR mutation-positive non-small-cell lung cancer (NSCLC).1 337 patients were randomly assigned (1:1) to limertinib or gefitinib. Patients' median age was 63 years (IQR 34–82). 214 (64%) of 337 patients were female and 123 (36%) were male. The trial met its primary endpoint with a median masked independent central review (ICR)-assessed progression-free survival (PFS) of 20·7 months (95% CI 15·2–22·1) in the limertinib group versus 9·7 months (95% CI 8·3–11·1) in the gefitinib group (hazard ratio 0·44 [95% CI 0·34–0·58]; p<0·0001). Masked ICR-assessed intracranial response rates and intracranial PFS were longer in the limertinib group than in the gefitinib group. Overall survival data were not yet mature.1
The Lancet Respiratory Medicine , commentaire, 2025