Osimertinib after Chemoradiotherapy in Stage III EGFR-Mutated NSCLC

The LAURA study assesses the efficacy and safety of osimertinib following chemoradiation in patients with stage III unresectable EGFR-mutated NSCLC.²

Methods

In this phase III, double-blind, placebo-controlled trial, patients with unresectable EGFR-mutated stage III NSCLC without progression during/after chemoradiotherapy were randomly assigned to receive osimertinib/placebo until disease progression occurred or the regimen was discontinued. The primary end-point was progression-free survival (PFS) as assessed by blinded independent central review.

Findings

Two hundred and sixteen patients who had undergone chemoradiotherapy were randomly assigned to receive osimertinib (143 patients) or placebo (73 patients). Osimertinib resulted in a significant PFS benefit compared with placebo: the median PFS was 39.1 months with osimertinib vs. 5.6 months with placebo, with a hazard ratio for disease progression or death of 0.16 (95% confidence interval [CI], 0.10 to 0.24; p<0.001). The percentage of patients who were alive and progression free at twelve months was 74% (95% CI, 65-80) with osimertinib and 22% (95% CI, 13-32) with placebo. Interim overall survival data (maturity, 20%) showed 36-month overall survival among 84% of patients with osimertinib (95% CI, 75-89) and 74% with placebo (95% CI, 57-85), with a hazard ratio for death of 0.81 (95% CI, 0.42-1.56; p=0.53). The incidence of adverse events of grade ≥3 was 35% in the osimertinib group and 12% in the placebo group; radiation pneumonitis (majority grade, 1-2) was reported in 48% and 38%, respectively. No new safety concerns emerged.

Conclusion

Treatment with osimertinib resulted in significantly longer PFS than placebo in patients with unresectable stage III EGFR-mutated NSCLC.¹

References

1. Lu S, Kato T, Dong X, et al. Osimertinib after Chemoradiotherapy in Stage III EGFR-Mutated NSCLC. N Engl J Med. 2024. June. Online ahead of print.

2. ClinicalTrials.gov ID NCT03521154. A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter, International Study of Osimertinib as Maintenance Therapy in Patients With Locally Advanced, Unresectable EGFR Mutation-positive Non-Small Cell Lung Cancer (Stage III) Whose Disease Has Not Progressed Following Definitive Platinum-based Chemoradiation Therapy (LAURA). Accessed on 24 June 2024.