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MEDTECH Osimertinib shows significant benefits in progression-free survival for patients with unresectable stage III EGFR-mutated NSCLC after chemoradiotherapy, indicating potential implications for long-term management of advanced lung cancer.
A recent phase 3, double-blind, placebo-controlled trial investigated the efficacy of osimertinib as a treatment for patients with unresectable stage III non–small-cell lung cancer (NSCLC) harboring EGFR mutations who did not show disease progression during or after chemoradiotherapy. The study aimed to determine if osimertinib could extend progression-free survival in this patient population compared to placebo.
Study Design:
- Participants: 216 patients with unresectable stage III EGFR-mutated NSCLC without progression during or after chemoradiotherapy.
- Randomization: Patients were randomly assigned to receive either osimertinib (143 patients) or placebo (73 patients).
- Primary Endpoint: Progression-free survival assessed by blinded independent central review.
- Follow-up: Interim overall survival data collected with a 20% maturity at 36 months.
Key Findings:
- Progression-Free Survival: Median progression-free survival was 39.1 months with osimertinib versus 5.6 months with placebo (hazard ratio for disease progression or death: 0.16; 95% CI, 0.10 to 0.24; P<0.001).
- Survival at 12 Months: 74% of patients on osimertinib were alive and progression-free at 12 months compared to 22% on placebo.
- Overall Survival: Interim data showed 36-month overall survival of 84% in the osimertinib group versus 74% in the placebo group (hazard ratio for death: 0.81; 95% CI, 0.42 to 1.56; P=0.53).
- Adverse Events: Grade 3 or higher adverse events occurred in 35% of the osimertinib group and 12% of the placebo group. Radiation pneumonitis (mostly grade 1-2) was reported in 48% of the osimertinib group and 38% of the placebo group.
- Safety: No new safety concerns emerged during the trial.
HCN Medical Memo
The LAURA trial demonstrates that osimertinib provides a substantial benefit in progression-free survival for patients with unresectable stage III EGFR-mutated NSCLC following chemoradiotherapy. This finding suggests a promising option for extending disease control in this challenging patient population.
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