First-line osimertinib was associated with a clinically meaningful progression-free survival (PFS) improvement when compared to a standard-of-care (SOC) epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI) in a sub-analysis of Asian patients who participated in the FLAURA trial (NCT02296125).

The Phase III FLAURA trial recruited 322 Asian patients at Asian sites with previously untreated advanced non-small cell lung cancer (NSCLC) and confirmed exon 19 deletion (Ex19del)/L858R EGFR-TKI sensitising mutations (EGFRm). Participants were randomised 1:1 to either receive osimertinib at 80 mg once daily (QD) orally (PO) or another SOC EGFR-TKI (erlotinib 150 mg QD PO, or gefitinib 250 mg QD PO). The primary efficacy endpoint was the investigator-assessed PFS. Secondary endpoints included the overall survival (OS), the objective response rate (ORR), the central nervous system (CNS) efficacy, and safety.

The median PFS was 16.5 months in the osimertinib patients vs 11.0 months in patients treated with SOC EGFR-TKI (HR=0.54; 95% CI, 0.41–0.72; p<0.0001). The ORR was 80% vs 75% for osimertinib vs SOC EGFR-TKI, respectively. The median CNS PFS was not yet evaluable for the osimertinib group and measured 13.8 months for the SOC EGFR-TKI group (HR=0.55; 95% CI, 0.25–1.17; p=0.118). The OS data were not yet mature.

The safety profile in this Asian subset was consistent with the safety in the overall FLAURA study population. Osimeritinib was associated with fewer Grade ≥3 adverse events (AEs): 40% vs 48% with SOC EGFR-TKI. Furthermore, AEs leading to treatment discontinuation occurred less frequent with osimertinib when compared to SOC EGFR-TKI: 15% vs 21%, respectively.