1. After a 3-year follow-up to a phase 3 trial, the epidermal growth factor receptor-tyrosine kinase inhibitor osimertinib resulted in a longer median overall survival versus comparator EGFR-TKIs with similar safety profiles.
2. Benefits appeared to extend across most predefined subgroups including sex, age, and smoking history, although there was substantial overlap between confidence intervals.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) are effective in managing sensitized non-small cell lung cancer. The third-generation irreversible EGFR-TKI osimertinib inhibits both EGFR-TKI-sensitizing and EGFR T790M resistance mutations and potentially penetrates the blood-brain barrier to directly interact with the central nervous system (CNS). The phase 3 FLAURA trial showed significantly longer progression-free survival in the osimertinib group than in the EGFR-TKI comparator group, but overall survival data were immature at the time of the primary analysis. In this final analysis, median overall survival was also found to be substantially higher in the osimertinib group. No new safety signals were detected, with grade 3 or higher adverse events and treatment discontinuation occurring at similar rates in both groups. Strengths of this study included a double-blind design, a representative trial population, and confirmation of mutation status. One limitation was that the newer EGFR-TKI afatinib was not included in the comparator group, somewhat limiting the clinical significance of the study’s results.
Click here to read the study in NEJM
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