Treatment with osimertinib in patients with unresectable stage III, EGFR-mutated non-small cell lung cancer (NSCLC) after definitive chemoradiotherapy does strongly improve progression-free survival (PFS), as shown in phase 3 LAURA trial.
In unresectable stage III NSCLC following chemoradiotherapy without progression, consolidation therapy with durvalumab is standard of care1. However, the benefit of consolidation with durvalumab is uncertain in patients with EGRF-mutated NSCLC2.
Based on real world data and a result from a phase 2 study, phase 3 LAURA trial (NCT03521154) evaluated the efficacy and safety of EGFR-tyrosine kinase inhibitor osimertinib in patients with unresectable, stage III, EGFR-mutated NSCLC with no progression during or following definitive chemoradiotherapy.
A total of 216 patients were 2:1 randomized to receive osimertinib (80 mg daily) until disease progression, toxicity, or placebo. Participants receiving placebo were allowed to cross-over to osimertinib after progression. The primary outcome measurement was PFS. Prof. Suresh Ramalingam of Emory University, MD, FACP, in Georgia, presented the primary results3.
Osimertinib demonstrated a statistically significant and clinically meaningful improvement in PFS. Median PFS in participants treated with osimertinib was 39.1 months (95% CI 31.5-NA) versus 5.6 months (95% CI 3.7-7.4) in participants treated with placebo (HR 0.16; 95% CI 0.10 –0.24; P<0.001). At 24 months, PFS rate in both arms was 65% and 13%, respectively. PFS benefit with osimertinib was observed in all key subgroups: sex, age, stage, EGFR mutation, and response to prior chemoradiotherapy.
In addition, the objective response rate was improved by osimertinib (57% vs 33%) as was the median duration of response (36.9 vs 6.5 months). Participants treated with osimertinib were less likely to develop new lesions (22% vs 68%), particularly in the brain (8% vs 29%). Overall survival data are not yet mature. In the placebo arm, 81% of patients did cross over to osimertinib after confirmed progression.
Based on these primary results, Prof. Ramalingam expected “osimertinib to become the new standard of care for patients with unresectable stage III, EGFR-mutated NSCLC who have not progressed after definitive chemoradiotherapy.”
Medical writing support was provided by Marten Dooper, PhD.
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