A groundbreaking Phase 3 clinical trial has revealed that osimertinib, a third-generation EGFR tyrosine kinase inhibitor, significantly extends progression-free survival (PFS) in patients with unresectable stage III EGFR-mutant non-small cell lung cancer (NSCLC) following definitive chemoradiotherapy (CRT). The international study, known as LAURA, involved 216 patients and was conducted across multiple countries.
Patients eligible for the trial were 18 years or older, had stage III EGFR-mutant NSCLC, and had completed platinum-based CRT without disease progression. They were randomly assigned in a 2:1 ratio to receive either osimertinib or a placebo daily until disease progression.
Results showed a dramatic improvement in PFS for the osimertinib group compared to the placebo group. Median PFS was 39.1 months for patients on osimertinib, versus 5.6 months for those on the placebo (HR 0.16; 95% CI 0.10, 0.24; p<0.001). The 12-month PFS rate was 74% for osimertinib compared to 22% for the placebo, and the 24-month PFS rate was 65% versus 13%, respectively.
The safety profile indicated that 98% of patients on osimertinib experienced adverse events (AEs), compared to 88% in the placebo group. Serious AEs were reported in 38% of the osimertinib group and 15% of the placebo group, with most side effects being manageable and expected based on previous studies.
These findings suggest that osimertinib should become the new standard of care for patients with unresectable stage III EGFR-mutant NSCLC, offering a significant improvement in disease management and patient outcomes.
Reference:
Ramalingam S et al. Osimertinib (osi) after definitive chemoradiotherapy (CRT) in patients (pts) with unresectable stage (stg) III epidermal growth factor receptor-mutated (EGFRm) NSCLC: Primary results of the phase 3 LAURA study. ASCO 2024.
