Osimertinib (Tagrisso) has demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) compared with standard first-generation EGFR tyrosine kinase inhibitors (TKIs) in patients with newly diagnosed EGFR-mutated non–small cell lung cancer (NSCLC), according to updated findings from the phase III FLAURA trial.1
OS was a key secondary endpoint of the FLAURA trial, which had already met its primary endpoint of improvement in progression-free survival (PFS) in 2017.2 The PFS benefit seen in the FLAURA trial led to the FDA approval of osimertinib as a frontline treatment for patients with NSCLC harboring EGFR mutations in 2018. These updated findings show that the third-generation, irreversible EGFR TKI also improves OS in this setting.
“Today’s positive results show that Tagrisso provides an unprecedented survival outcome versus previous standard-of-care EGFR TKIs, reaffirming Tagrisso as the first-line standard-of-care for EGFR-mutated metastatic NSCLC,” said José Baselga, MD, PhD, executive vice president, Oncology Research & Development, AstraZeneca, in a press release announcing the OS findings.
The company plans to present the full OS findings from FLAURA at an upcoming medical meeting.
The randomized, double-blind phase III trial enrolled 556 treatment-naïve patients with EGFR-positive locally advanced or metastatic NSCLC who were randomly assigned to receive either osimertinib (n = 279) or standard first-generation EGFR TKIs of erlotinib (Tarceva) or gefitinib (Iressa) (n = 277).2 Patients received a daily oral therapy of osimertinib (80 mg), gefitinib (250 mg), or erlotinib (150 mg).