Osimertinib after chemoradiotherapy for stage III non-small cell lung cancer (NSCLC) with EGFR mutation

Key message

In this phase III trial, patients with unresectable stage III EGFR-mutated non-small cell lung cancer (NSCLC) who had not experienced disease progression during or after chemoradiotherapy were randomized to receive osimertinib or placebo until disease progression or treatment discontinuation. care. Osimertinib significantly improved progression-free survival compared with placebo: mean 39.1 months versus 5.6 months. At 12 months, 74% of patients treated with osimertinib were alive and progression-free, compared with 22% in the placebo group. At 36 months, overall survival was 84% ​​for the osimertinib group compared with 74% for the placebo group. No new safety issues were identified.

Study shows that osimertinib after chemoradiotherapy significantly prolongs progression-free survival in patients with unresectable stage III EGFR-mutated NSCLC.

SUMMARY

BACKGROUND

Osimertinib is recommended for the treatment of advanced epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) and as the adjuvant treatment of resected EGFR-mutated NSCLC. EGFR tyrosine kinase inhibitors have shown preliminary efficacy in unresectable stage III EGFR-mutated NSCLC.

METHODS

In this double-blind, placebo-controlled, phase 3 trial, we randomly assigned patients with unresectable stage III EGFR-mutated NSCLC without progression during or after chemoradiotherapy to receive osimertinib or placebo until disease progression (assessed by an independent, blinded central specialist). review) or the mode has been terminated. The primary endpoint was progression-free survival assessed by an independent central blind review.

RESULTS

A total of 216 patients receiving chemoradiotherapy were randomized to receive osimertinib (143 patients) or placebo (73 patients). Osimertinib resulted in a significant increase in progression-free survival compared with placebo: median progression-free survival was 39.1 months in the osimertinib group compared with 5.6 months in the placebo group, with a hazard ratio for disease progression or death of 0.16 (95% confidence level interval (CI), 0.10 to 0.24;

CONCLUSIONS

Treatment with osimertinib resulted in significantly longer progression-free survival than placebo in patients with unresectable stage III EGFR-mutated NSCLC.

Recommendations

Shun Lu, Terufumi Kato, Xiaorun Dong and others.

DOI: 10.1056/NEJMoa2402614

Link: https://www.nejm.org/doi/10.1056/NEJMoa2402614

Fountain: BioPress