ESMO 2017 | FLAURA study: a new standard of care for patients with EGFR mutated NSCLC

Osimertinib improves progression-free survival by 54% compared to standard first line therapy in patients with EGFR mutated non-small-cell lung cancer (NSCLC), according to late-breaking results from the FLAURA trial presented today at the ESMO 2017 Congress in Madrid.

EGFR mutations are present in around 15% of NSCLC in Western populations, rising to 35% in Asian populations. EGFR inhibitors are superior to chemotherapy in the first line treatment of these patients. However, despite high response rates and good progression-free survival, patients invariably develop resistance to drugs such as erlotinib and gefitinib. In the majority of patients this resistance is mediated by a T790M mutation.

“We hypothesised that a drug which targets EGFR sensitising mutations and the T790M resistance mutation would be associated with a better outcome,” said principal investigator Professor Suresh Ramalingam, MD, Deputy Director, Winship Cancer Institute of Emory University, Atlanta, Georgia, US.

Osimertinib is a third generation EGFR-tyrosine kinase inhibitor (TKI) that potently and selectively inhibits both EGFR and T790M resistance mutations. A preliminary study in 60 treatment naive patients with EGFR mutations found that the median progression-free survival with osimertinib was 20.5 months, which was almost two-fold higher than results achieved with erlotinib or gefitinib.

Ramalingam said: “Osimertinib was clearly superior to standard first line treatment in patients with EGFR mutated NSCLC. The progression-free survival benefit for patients with and without brain metastases was almost identical, suggesting that osimertinib is active in the brain as well as in systemic sites. This is important because brain metastasis is a common problem in EGFR mutated patients.”

This session was recorded at the ESMO 2017 Congress in Madrid