ESMO Asia 2017: FLAURA Trial: Osimertinib Improves Progression-Free Survival in Asian Patients With EGFR-Mutated NSCLC

Key Points

  • The median progression-free survival was 16.5 months with osimertinib compared to 11.0 months for the standard therapy.
  • The median duration of response was two-fold higher for patients treated with osimertinib (17.6 months) compared to standard of care (8.7 months). The overall response rate was 80% with osimertinib compared to 75% with standard of care treatment.
  • The incidence of grade 3 or higher toxicities was lower for osimertinib (40%) than the standard treatment (48%).

Osimertinib (Tagrisso) improves progression-free survival compared to standard first-line therapy in Asian patients with EGFR-mutated non–small cell lung cancer (NSCLC), according to the Asian subset analysis of the FLAURA trial presented at the European Society for Medical Oncology (ESMO) Asia 2017 Congress (Abstract LBA6_PR) and simultaneously published by Soria et al in The New England Journal of Medicine.

EGFR mutations occur in 30% to 40% of NSCLC in Asian populations compared to 10% to 15% in Western populations. The phase III FLAURA trial compared osimertinib, a third-generation EGFR tyrosine kinase inhibitor, to standard of care EGFR tyrosine kinase inhibitors (erlotinib [Tarceva] or gefitinib [Iressa]) as first-line therapy in NSCLC patients with EGFR mutations. A total of 556 patients from Asia, Europe, and North America were randomized 1:1 to treatment with osimertinib or standard of care. Osimertinib improved progression-free survival by 54%.

This subset analysis included the 322 Asian patients in the FLAURA trial, of whom 46 were Chinese, 120 were Japanese, and 156 were from other parts of Asia.

Results

The median progression-free survival was 16.5 months with osimertinib compared to 11.0 months for the standard therapy, with a hazard ratio of 0.54 (95% confidence interval = 0.41–0.72; P < .0001).

The median duration of response was two-fold higher for patients treated with osimertinib (17.6 months) compared to standard of care (8.7 months). The overall response rate was 80% with osimertinib compared to 75% with standard of care treatment. Median overall survival was not reached.

The incidence of grade 3 or higher toxicities was lower for osimertinib (40%) than the standard treatment (48%).

Lead author Byoung Chul Cho, MD, PhD, of Yonsei Cancer Center in Seoul, Korea, said, “As in the overall trial population, osimertinib provided a significant progression-free survival benefit in Asian patients with EGFR-mutated NSCLC. Asian patients had similar toxicities with osimertinib as the overall FLAURA population. Osimertinib should be the preferred first-line treatment for EGFR-mutant NSCLC in Asia.”

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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