New Indication: Osimertinib after Chemoradiotherapy in NSCLC


  • Study

    Phase 3, double-blind, placebo-controlled trial (LAURA)
    Locally advanced, unresectable stage III NSCLC with EGFR exon 19 deletion or L858R mutation after chemoradiation
    Osimertinib (80 mg once daily) vs. placebo



  • Efficacy

    mPFS: 39.1 [31.5 mos – NR] vs. 5.6 mos[3.7 – 7.4 mos] (HR: 0.16 [0.10-0.24])
    OS @36 mos: 84% vs. 74% (NS)



  • Safety

    Any Grade AEs: Radiation pneumonitis (48%), diarrhea (36%), rash (24%)
    Grade ≥3 AEs: Osimertinib 35%, Placebo 12%
    Serious AEs: Osimertinib 38%, Placebo 15%
    Fatal AEs: Osimertinib 2%, Placebo 3%



  • N Engl J Med 2024;391:585-97

    Lu S,Kato T,Dong X Osimertinib after Chemoradiotherapy in Stage III EGFR-Mutated NSCLC

    http://doi.org/10.1056/NEJMoa2402614

    Reviewed by Ulas D. Bayraktar, MD on Sep 30, 2024