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Suresh S. Ramalingam, MD, deputy director, Winship Cancer Institute of Emory University, discusses the phase III results of the FLAURA trial, which explored osimertinib (Tagrisso) in the frontline setting for patients with EGFR-mutant non-small cell lung cancer (NSCLC).
Suresh S. Ramalingam, MD, deputy director, Winship Cancer Institute of Emory University, discusses the phase III results of the FLAURA trial, which explored osimertinib (Tagrisso) in the frontline setting for patients with EGFR-mutant non—small cell lung cancer (NSCLC).
The trial compared osimertinib with standard of care agents such as gefitinib (Iressa) and erlotinib (Tarceva) as a frontline therapy; currently, osimertinib is FDA approved for second-line therapy for patients who developed the T790M resistance mechanism. The trial enrolled 556 patients, with a primary endpoint of progression-free survival (PFS) as assessed by the investigator, Ramalingam says.
Results showed that the median PFS with osimertinib was 18.9 months versus 10.2 months with standard of care; the hazard ratio was 0.46, leading to a 54% reduction in the risk of progression or death. Additionally, the duration of response was more than two-fold higher for patients treated with osimertinib. This was 8.5 months with standard therapy versus 17.2 months with osimertinib. Additionally, though the overall survival data are very immature, the hazard ratio is 0.63. This is a very promising trend, Ramalingam adds. Patients who had brain metastases also had a very promising response rates.