First-line Tagrisso® (osimertinib) improved overall survival (OS) compared with a comparator tyrosine kinase inhibitor (TKI) in patients with epidermal growth factor receptor (EGFR)-mutated, advanced non-small cell lung cancer (NSCLC), according to research presented at the ESMO Congress 2019.
The double-blind, phase III FLAURA study included adult patients with EGFR-mutated advanced NSCLC who were randomized 1:1 to receive osimertinib 80 mg orally once daily (n=279) or gefitinib 250 mg or Tarceva® (erlotinib) 150 mg orally daily (n=277; comparator cohort).
Improved survival with osimertinib
Median OS was 38.6 months (95.05% CI, 34.5-41.8) in the osimertinib group versus 31.8 months (95.05% CI, 26.6-36.0) in those receiving gefitinib or erlotinib (hazard ratio = 0.799; 95.05% CI, 0.641-0.997; P=0.0462), resulting in a 20% reduced risk of progression or death in the osimertinib cohort. The 12-, 24-, and 36-month OS rates in the osimertinib and comparator cohorts were 89% versus 83%, 74% versus 59%, and 54% versus 44%, respectively. The median follow-up for OS was 35.8 months with osimertinib and 27.0 months with the comparator agents.
Median progression-free survival was also significantly higher with osimertinib (18.9 vs. 10.2 months).
A total of 155 (56%) deaths occurred in the osimertinib arms compared with 166 (60%) in the comparator arm. One-quarter of patients in the comparator arm crossed over to the osimertinib cohort.
Adverse events (AEs) occurred in 98% of patients in both cohorts. Grade ≥3 AEs occurred in 42% of osimertinib-treated patients and 47% of comparator-treated patients. AEs leading to discontinuation occurred in 15% of patients receiving osimertinib versus 18% of patients receiving comparator treatment.
The researchers concluded that “frontline osimertinib provided a statistically significant and clinically meaningful improvement in OS versus the comparator EGFR TKI in patients with EGFR-mutated advanced NSCLC.”
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