LAURA trial (ASCO plenary)

Based on the results of the phase III PACIFIC trial, consolidation therapy with durvalumab has become the standard of care for patients with unresectable stage III NSCLC who did not suffer disease progression under chemoradiotherapy (CRT). However, a post-hoc analysis of this trial indicates that this treatment strategy does not improve outcomes for patients with an activating EGFR mutation. To address this unmet medical need, the phase III LAURA study evaluated the impact of consolidation therapy with osimertinib following CRT in patients with unresectable stage III, EGFR-mutated NSCLC. The results of this trial were presented by Prof Dr Suresh Ramalingam (Emory University School of Medicine, Winship Cancer Institute, Atlanta, GA, USA) during the plenary session at ASCO 2024.

The LAURA trial is a randomized, placebo-controlled, phase III study in which 216 patients with locally advanced, unresectable, stage III, EGFR-mutated NSCLC who did not have disease progression during or after definitive CRT were randomly assigned (2:1) to receive osimertinib (80 mg once daily), or placebo.

Consolidation therapy with osimertinib resulted in a median progression-free survival (PFS) of 39.1 months, as compared to 5.6 months in the placebo arm. This difference corresponds to a highly significant 84% reduction in the risk for disease progression or death with osimertinib compared to placebo (HR[95%CI]: 0.16[0.10-0.24]; p< 0.001). At the 2-year landmark, 65% of patients in the osimertinib arm were alive and free of progression as compared to 13% in the placebo arm. Data for overall survival (OS) are immature. However, despite 81% of patients in the placebo arm crossing over to osimertinib, a trend for a better OS was already apparent in favor of consolidation osimertinib.

The safety profile in both treatment arms was consistent with the known safety profiles of osimertinib and CRT. Most of the adverse events observed with consolidation osimertinib were non-serious, low-grade, and generally did not require a treatment discontinuation.

For Prof Ramalingam these results establish osimertinib as the new standard of care for patients with EGFR-mutated, unresectable stage III NSCLC. More mature data are eagerly awaited to see whether the impressive delay in disease progression obtained with consolidation osimertinib also translates into a longer OS for patients.