Swissmedic has approved osimertinib for the treatment of adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) that harbors EGFR exon 19 deletions or exon 21 (L858R) mutations, following definitive platinum-based chemoradiation therapy (CRT) and without disease progression.
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This approval is based on the LAURA Phase III trial results, which were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The New England Journal of Medicine. The LAURA trial, a randomized, double-blind, placebo-controlled global study, evaluated osimertinib in patients with unresectable, Stage III EGFR-mutated NSCLC whose disease had not progressed after CRT. Patients received 80mg of osimertinib daily until disease progression or unacceptable toxicity. Notably, patients in the placebo group could switch to osimertinib if their disease progressed.
Osimertinib demonstrated an 84% reduction in the risk of disease progression or death compared to placebo (HR 0.16, 95% CI 0.10-0.24, p<0.001). The median progression-free survival (PFS) was 39.1 months for osimertinib, versus 5.6 months for placebo. Additionally, osimertinib significantly delayed cancer spread to the central nervous system (CNS), with the median CNS PFS not reached in the osimertinib group, compared to 14.9 months in the placebo group. At 12 months, the cumulative incidence of CNS progression was 9% with osimertinib versus 36% with placebo.
While the trial continues to evaluate overall survival (OS), the safety profile of osimertinib showed that 35% of patients experienced grade 3 or higher adverse events, compared to 12% in the placebo group. Radiation pneumonitis was reported in 48% of patients receiving osimertinib and 38% in the placebo group.
Osimertinib’s approval represents a major advancement for patients with EGFR-mutated NSCLC, offering extended disease control and robust protection against CNS metastases. This decision sets a new standard of care for this patient population.
References
- Swissmedicinfo.ch
- S. Lu et al., “Osimertinib after Chemoradiotherapy in Stage III EGFR -Mutated NSCLC,” New England Journal of Medicine, vol. 391, no. 7, pp. 585–597, Jun. 2024, doi: 10.1056/nejmoa2402614.
- S. Lu et al., “Osimertinib after definitive chemoradiotherapy in unresectable stage III epidermal growth factor receptor-mutated non-small-cell lung cancer: analyses of central nervous system efficacy and distant progression from the phase III LAURA study,” Annals of Oncology, Sep. 2024, doi: 10.1016/j.annonc.2024.08.2243.
FDA Approval
