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- Title
Osimertinib, nuova opzione terapeutica upfront per il tumore polmonare non a piccole cellule EGFR-mutato.
- Authors
Capelletto, Enrica; Novello, Silvia
- Abstract
Osimertinib is an orally available third-generation EGFR-TKI (Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor) that potently inhibits both EGFR activating and T790M resistance mutations, with well demonstrated intracranial activity. It exhibited remarkable activity and superiority over platinum/pemetrexed chemotherapy in NSCLC (Non Small Cell Lung Cancer) patients with acquired EGFR T790M mutations caused by prior EGFR-TKI exposure, being now the standard of care for this subset of patients, even with central nervous system metastases. The randomized phase III FLAURA study has compared the efficacy of osimertinib to first-generation EGFR-TKIs (gefitinib or erlotinib, according to investigators' choice) as upfront treatment for newly diagnosed EGFR mutation positive NSCLC, showing a statistically significant benefit over the standard of care in Progression-Free Survival (PFS), primary endpoint of the study (18.9 vs 10.2 months, respectively; HR: 0.46; p-value < 0.001). At the time of first analysis, Overall Survival (OS) data were immature. Recently, at the annual European meeting of Medical Oncology, it has been reported the final OS analysis (secondary endpoint of the study): at data cut-off, when 58% of events were mature, osimertinib significantly improved median OS versus comparator EGFR-TKI (38.6 vs 31.8 months, respectively; HR: 0.799; p-value = 0.0462). After three years from treatment start, 28% of patients in the osimertinib arm and 9% of patients in the comparator EGFR-TKI arm remained on first-line study therapy, being toxicity profile globally well tolerated, despite prolonged exposure. Basing on survival and safety data from the FLAURA study, osimertinib can now change the therapeutic algorithm for patients with EGFR mutation positive advanced NSCLC, and really be considered the upfront standard of care for these patients.
- Publication
Rassegna di Patologia dell'Apparato Respiratorio, 2019, Vol 34, Issue 5/6, p134
- ISSN
0033-9563
- Publication type
Article