Results from the LAURA study, presented at the plenary session of the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, are set to revolutionize the treatment landscape for patients with unresectable stage III EGFR-mutated non-small cell lung cancer (NSCLC).
In the phase 3 study, 216 patients with unresectable stage III EGFR-mutated NSCLC who completed definitive chemoradiotherapy were randomly assigned to receive osimertinib (n=143) or placebo (n=73). Treatment was continued until disease progression. The primary endpoint of the study was progression-free survival (PFS) as assessed by blinded independent central review.
Median PFS was significantly improved with osimertinib treatment compared with placebo (39.1 vs 5.6 months; hazard ratio [HR] 0.16, P<0.0001). The impressive improvement in PFS was found across all key subgroups evaluated. The objective response rate (ORR) was 57% with osimertinib with a median duration of response (mDOR) of 36.9 months, and the rates of brain metastases were reduced with osimertinib (8% vs 29%). At 20% maturity, there was no significant difference in overall survival detected. (Table 1)
The safety profile of osimertinib was consistent with previous studies of osimertinib treatment for NSCLC. The most common grade ≥3 adverse events were radiation pneumonitis, skin rash, and diarrhea. (Table 2) Interstitial lung disease (ILD) was reported in 11 patients (8%) treated with osimertinib. While the majority of ILD cases were grades 1 or 2, there was 1 death on study due to ILD.
These practice-changing results, simultaneously published in the New England Journal of Medicine, establish osimertinib after chemoradiotherapy as the new standard of care for patients with unresectable stage III EGFR-mutated NSCLC, and emphasize the importance of determining EGFR biomarker status in this patient population.
Ramalingam S, et al. J Clin Oncol. 2024. 42(suppl 17): LBA4.
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