Primary Results of Consolidation Osimertinib (Tagresso) after Definitive Chemoradiotherapy in Patients with Unresected Stage III EGFR-Mutant NSCLC from a Phase 3 LAURA Study

The standard of care for unresectable stage III NSCLC is consolidation durvalumab following definitive chemoradiotherapy as per the PACIFIC regimen. However, the efficacy of consolidative durvalumab in EGFR-mutated NSCLC remains uncertain, according to post-hoc subgroup analysis of the PACIFIC study. A retrospective study reported at the 2023 WCLC showed that consolidation osimertinib provided superior disease-free survival (DFS) compared to consolidation durvalumab or observation in patients harboring EGFR sensitizing mutations after chemoradiotherapy.

LAURA is a phase III, placebo-controlled, double-blind prospective study designed to assess the efficacy of consolidation osimertinib in unresectable stage III EGFR-mutant NSCLC. Subjects were randomized in a 2:1 ratio to receive either osimertinib or placebo. Consolidation osimertinib demonstrated a significant progression-free survival (PFS) benefit over the control arm, with a median PFS of 39.1 months compared to 5.6 months for placebo (hazard ratio [HR]: 0.16, p < 0.001) as determined by blinded independent central review (BICR). The objective response rate (ORR) was 57% in the osimertinib arm and 33% in the placebo arm. The incidence of new lesions was significantly lower in the osimertinib arm compared to the placebo arm (22% vs. 66%).

The LAURA trial represents a practice-changing clinical study, providing a key piece of the puzzle for the treatment of unresectable stage III NSCLC with driver mutations. EGFR mutation testing is critical in stage III disease to determine the optimal treatment for patients harboring EGFR mutations.

Reference:

1. Suresh S. Ramalingam et al., Osimertinib (osi) after definitive chemoradiotherapy (CRT) in patients (pts) with unresectable stage (stg) III epidermal growth factor receptor-mutated (EGFRm) NSCLC: Primary results of the phase 3 LAURA study. JCO 42, LBA4-LBA4(2024).  

2. Amin Nassar Suresh et al., MA16.11 Consolidation EGFR-Tyrosine Kinase Inhibitor (TKI)vs. Durvalumab vs. Observation in Unresectable EGFR-Mutant Stage III NSCLC. JTO, Volume 18, Issue 11, Supplement,2023, Page S161,  

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