Non-small cell lung cancer (NSCLC) patients with an epidermal growth factor receptor (EGFR) mutation experienced substantial improvement in outcomes when treated with the drug osimertinib compared with those who receive standard of care treatment. The findings, released November 18 in the New England Journal of Medicine on-line, are based on results of the FLAURA study led by Suresh S. Ramalingam, MD, from Winship Cancer Institute of Emory University.
"These results usher in a new treatment paradigm for the treatment of patients with an EGFR-mutated lung cancer," says Ramalingam, Winship deputy director and the Roberto C. Goizueta Distinguished Chair for Cancer Research in the Emory School of Medicine. "The use of osimertinib resulted in a 54% reduction in the risk of progression of the disease or death as compared to the present standard treatment approach."
More than 550 patients, previously untreated for EGFR mutation-positive NSCLC, were enrolled in the phase III FLAURA study which was sponsored by Astra Zeneca. Investigators compared osimertinib, which inhibits EGFR (exons 19, 21 and T790M), to standard of care drugs that are currently used in treating NSCLC such as erlotinib and gefitinib. Patients who received osimertinib experienced median progression-free survival of 18.9 months versus 10.2 months for those on the standard regimen.
Ramalingam states: "patients receiving osimertinib had a two-fold increase in duration of response. They also tolerated the drug better and had fewer overall side effect."
NSCLC remains the leading cause of cancer-related deaths worldwide. About 15 percent of patients with NSCLC have an EGFR mutation. Ramalingam expects the study results could impact up to 15,000 patients a year in the United States.
The Food and Drug Adminstration (FDA) has recently granted the "Breakthrough Therapy" Designation for osimertinib for first line therapy of EGFR mutation positive patients.