Trial results for osimertinib (Tagrisso) in patients with Stage III unresectable Epidermal Growth Factor Receptor Mutation Positive non-small cell lung cancer (NSCLC) were posted on ClinicalTrials.gov on 2025-04-03. The LAURA study (NCT03521154) demonstrated that osimertinib extended median progression-free survival (PFS) to 39.13 months compared to 5.55 months for placebo, with a Hazard Ratio of 0.16 (p=0.001).
Background
Non-small cell lung cancer (NSCLC) is a common and serious form of lung cancer. Stage III unresectable NSCLC, particularly in patients with Epidermal Growth Factor Receptor (EGFR) mutations, presents a significant clinical challenge. Treatment strategies often involve chemoradiation, and there is an ongoing need for therapies that can extend progression-free survival in this patient population.
Trial design
The global Phase 3 LAURA study (NCT03521154) enrolled 216 participants with Stage III unresectable Epidermal Growth Factor Receptor Mutation Positive non-small cell lung cancer following chemoradiation. The study assessed the efficacy and safety of osimertinib (80mg/40mg) compared to placebo osimertinib (80mg/40mg). The primary outcome measured was Progression-free Survival (PFS) by Blinded Independent Central Review (BICR).
Key results
The trial's key results for Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) were:
- Median PFS for the Osimertinib group was 39.13 months.
- Median PFS for the Placebo group was 5.55 months.
The overall Hazard Ratio (HR) for PFS was 0.16 (95% Confidence Interval: 0.1 to 0.24), with a p-value of 0.001 (Log Rank method).
Subgroup analyses for PFS showed:
- For Ex19Del positive patients, the HR was 0.17 (95% Confidence Interval: 0.1 to 0.29).
- For L858R positive patients, the HR was 0.32 (95% Confidence Interval: 0.19 to 0.56).
Regarding the number of participants with Progression-free Survival events in patients with EGFR Ex19del or L858R Mutation, there were 26 participants in the Osimertinib group and 39 participants in the Placebo group.
For participants with Progression-free Survival events in patients with EGFR Mutations Ex19del or L858R Detectable in Plasma-derived ctDNA, there were 42 participants in the Osimertinib group and 51 participants in the Placebo group.
What this means
The LAURA trial results indicate a substantial extension in progression-free survival for patients with Stage III unresectable EGFRm+ NSCLC treated with osimertinib following chemoradiation. The median PFS of 39.13 months for osimertinib compared to 5.55 months for placebo, along with a highly significant Hazard Ratio of 0.16, suggests a clinically meaningful benefit. This data supports the potential role of osimertinib as a post-chemoradiation therapy in this specific patient population, aiming to delay disease progression.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03521154, titled "A Global Study to Assess the Effects of Osimertinib Following Chemoradiation in Patients With Stage III Unresectable Non-small Cell Lung Cancer (LAURA)," were posted on 2025-04-03 on clinicaltrials.gov.