Results from the Phase III FLAURA trial which provide data for osimertinib use in the 1st-line treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) have been published in the New England Journal of Medicine.

The trial showed a statistically significant, clinically meaningful progression-free survival (PFS) advantage for osimertinib, a third-generation, irreversible EGFR tyrosine kinase inhibitor (TKI), compared with current 1st-line EGFR-TKIs, erlotinib or gefitinib.

Osimertinib has already been granted a breakthrough therapy by the US FDA.

Dr. Suresh S. Ramalingam, Principal Investigator of the FLAURA trial, from the Winship Cancer Institute of Emory University, Atlanta, USA, said “The results of the FLAURA trial may herald a shift in how we treat patients with EGFR-mutated NSCLC. The data demonstrate superiority of osimertinib compared to current standard EGFR-TKIs in the 1st-line setting.”

Dr Ramalingnam previously met with ecancer at the ESMO Congress 2017 to discuss earlier findings in which osimertinib extended progression-free survival. 

In the Phase III FLAURA trial, osimertinib significantly improved PFS compared to erlotinib or gefitinib in previously untreated patients with locally advanced or metastatic EGFR-mutated (EGFRm) NSCLC.

Median PFS was nearly doubled at 18.9 months for osimertinib compared with 10.2 months for the EGFR-TKI comparator arm (PFS, hazard ratio [HR] 0.46; 95% confidence interval [CI] 0.37-0.57; p<0.001).

Preliminary overall survival (OS) data favoured osimertinib with a 37% reduction in the risk of death (HR 0.63, 95% CI 0.45-0.88; p=0.007 [not significant]) at the interim OS analysis (25% maturity).

The FLAURA safety data for osimertinib were in line with those observed in prior clinical trials.

Osimertinib was well tolerated, with less frequent grade 3 or higher adverse events (AEs) than with standard EGFR-TKIs (34% vs. 45%).

In all patients, the most common AEs were rash or acne (58% [1% Grade ≥3] for osimertinib vs. 78% [7% Grade ≥3] for the comparator arm), diarrhoea (58% [2% Grade ≥3] for osimertinib vs. 57% [2% Grade ≥3] for the comparator arm), and dry skin (36% [<1% Grade ≥3] for osimertinib vs. 36% [1% Grade ≥3] for the comparator arm).

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said “EGFR-mutated NSCLC patients need new therapies that improve outcomes. The data published in NEJM today further emphasise the potential of osimertinib as a new treatment standard in this patient population.”

Source: BusinessWire