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Gregory J. Riely, MD, PhD
Gregory J. Riely, MD, PhD
Posted: Tuesday, June 4, 2024
Treatment with osimertinib vs a placebo conferred significantly improved progression-free survival and no unexpected safety signals in patients with unresectable, stage III EGFR-mutated non–small cell lung cancer (NSCLC) who did not experience disease progression after undergoing definitive platinum-based chemoradiotherapy, according to Suresh S. Ramalingam, MD, of Emory University School of Medicine, Atlanta, and colleagues. The primary results of the global phase III LAURA study, which were presented during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract LBA4), establish this third-generation EGFR tyrosine kinase inhibitor as the new standard of care in this setting.
Patients were randomly assigned in a 2:1 ratio to receive 80 mg of osimertinib (n = 143) or a placebo (n = 73) once daily. As assessed by blinded independent central review, osimertinib vs the placebo significantly improved progression-free survival (hazard ratio [HR] = 0.16; P < .001). Osimertinib prolonged the median duration of progression-free survival (39.1 vs 5.6 months); at 12 and 24 months, the rates were 74% and 65% with osimertinib and 22% and 13% with the placebo, respectively. The investigator-assessed analysis seemed to yield similar results (HR = 0.19; nominal P < .001). Across predefined subgroups, the progression-free survival benefit with osimertinib appeared to be consistent.
In the interim overall survival analysis, at 20% maturity, a trend in favor of osimertinib was seen (HR = 0.81; P = .530). Most of the patients who were treated with the placebo (82%) received osimertinib after experiencing disease progression.
All-causality adverse events were reported in 98% of patients treated with osimertinib and in 88% of those who received the placebo. A total of 48% and 38% of patients experienced a radiation pneumonitis–related adverse event, respectively, with the majority being grade 1 or 2. Adverse events leading to the discontinuation of treatment were documented more frequently with osimertinib (13%) vs the placebo (5%).
Disclosure: For full disclosures of the study authors, visit coi.asco.org.
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