Osimertinib as First-line Treatment of EGFR-Mutant Advanced NSCLC
Based on the results of a double-blind, phase III trial, osimertinib seems to be more effective than standard epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) in patients with previously untreated EGFR mutation–positive advanced non–small cell lung cancer (NSCLC), with a similar safety profile and lower rates of serious adverse events. These findings with this oral, third-generation EGFR TKI were reported by Jean-Charles Soria, MD, PhD, of Gustave Roussy Cancer Center, Villejuif, France, and colleagues in The New England Journal of Medicine.
A total of 556 patients with previously untreated, EGFR mutation–positive advanced NSCLC received either osimertinib (at a dose of 80 mg once daily) or a standard EGFR-TKI (gefitinib at a dose of 250 mg once daily or erlotinib at a dose of 150 mg once daily). Treatment continued until disease progression, the development of unacceptable side effects, or the patient withdrew consent.
The primary endpoint of the study was investigator-assessed progression-free survival. Analysis showed the median progression-free survival was significantly longer with osimertinib than with standard EGFR-TKIs (18.9 months vs. 10.2 months). Data on overall survival were immature, 25%, at the time of interim analysis. As for toxicity, adverse events of grade 3 or higher were more common with standard EGFR-TKIs than with osimertinib (45% vs. 34%).