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
