Osimertinib After Definitive Chemoradiotherapy in Unresectable Stage III EGFR-Mutated NSCLC: Subsequent Treatments and PPO From the Phase III LAURA Study
Mené sur 216 patients atteints d’un cancer du poumon non à petites cellules de stade III, non résécable, présentant une mutation de l’EGFR et ne montrant pas de progression pendant ou après une chimioradiothérapie, cet essai randomisé de phase III évalue l'efficacité, du point de vue de la survie globale, d'un traitement par osimertinib
Introduction: In the phase III LAURA study, osimertinib demonstrated statistically significant improvement in progression-free survival (PFS) versus placebo in patients with unresectable stage III EGFR-mutated non-small cell lung cancer (NSCLC) without disease progression during/after chemoradiotherapy. We report pre-specified post-progression outcomes, subsequent treatments and a second interim analysis of overall survival (OS).
Methods: Patients were randomized 2:1 to receive osimertinib or placebo until progression (blinded independent central review) or discontinuation. Open-label osimertinib was offered post-progression. Secondary endpoints included time to first and second subsequent treatment (TFST and TSST), second PFS (PFS2) and OS.
Results: At primary data cutoff (January 5, 2024), TFST (hazard ratio [HR], 0.13; 95% CI, 0.08–0.21), PFS2 (0.62; 0.35–1.08) and TSST (0.51; 0.28–0.91) were improved with osimertinib versus placebo. As reported previously, 63/143 (44%) and 66/73 (90%) patients had discontinued randomized osimertinib and placebo treatment, respectively. The most common first subsequent systemic treatment was an EGFR-tyrosine kinase inhibitor in the osimertinib and placebo arms (22/63 [35%] and 56/66 [85%], respectively), primarily osimertinib (14/63 [22%] and 50/66 [76%]). At the second interim OS analysis (data cutoff: November 29, 2024), there was a trend towards OS benefit with osimertinib versus placebo (HR, 0.67; 95% CI, 0.40–1.14; 31% maturity).
Conclusions: Osimertinib demonstrated clinically meaningful improvements versus placebo in TFST, PFS2 and TSST, and a trend towards OS benefit. These data indicate that clinical benefit with osimertinib was preserved beyond first progression, supporting long-term benefits of osimertinib for unresectable stage III EGFR-mutated NSCLC without progression during/after definitive chemoradiotherapy.
Clinical Cancer Research , article en libre accès, 2026