Osimertinib after definitive chemoradiotherapy in patients with unresectable stage III EGFR-mutated NSCLC: LAURA China cohort
Mené sur 216 patients atteints d'un cancer du poumon non à petites cellules de stade III non résécable avec mutation de l'EGFR et sans progression pendant ou après une chimioradiothérapie définitive, cet essai randomisé de phase III évalue l'intérêt, du point de vue de la survie sans progression, de l'osimertinib après traitement
Background: In the phase III LAURA study, osimertinib, a third-generation epidermal growth factor receptor (EGFR)–tyrosine kinase inhibitor 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 progression during/after definitive chemoradiotherapy (CRT); PFS hazard ratio 0.16; 95 % confidence interval (CI): 0.10–0.24; p < 0.001. Here we report pre–specified exploratory efficacy and safety analyses in the LAURA China cohort (which was a stratification factor).
Methods: Adults with unresectable stage III EGFR-mutated (exon 19 deletion/L858R) NSCLC without progression during/after CRT were randomized 2:1 to receive osimertinib 80 mg once daily or placebo until disease progression (per Response Evaluation Criteria in Solid Tumours version 1.1) or discontinuation. The primary endpoint was PFS by blinded independent central review (BICR). Secondary endpoints included overall survival, objective response rate (ORR), duration of response and safety.
Results: Of 216 patients randomized globally, 40 (19 %) were enrolled in mainland China, comprising the China cohort (osimertinib n = 27; placebo n = 13). Baseline characteristics were generally well-balanced between treatment arms. Median (95 % CI) BICR-assessed PFS was not reached (17.4–not calculable) versus 3.7 months (1.8–7.7) with osimertinib versus placebo, respectively. ORR (95 % CI) was 63 % (42–81) and 15 % (2–45), respectively. The majority of adverse events (AEs) were grade 1 or 2 in severity and did not lead to treatment discontinuation. No AEs led to dose reductions or death.
Conclusions: Osimertinib after definitive CRT demonstrated PFS benefit over placebo and a manageable safety profile in the China cohort, consistent with findings in the global LAURA population. The results support the use of osimertinib after definitive CRT as the new standard of care, globally and in China, for patients with unresectable stage III EGFR-mutated NSCLC.
Lung Cancer , résumé, 2026