medwireNews: The FLAURA trial comparing osimertinib with erlotinib or gefitinib in the first-line treatment of EGFR-mutated, advanced non-small-cell lung cancer (NSCLC) has shown positive overall survival (OS) results favoring the third-generation EGFR–tyrosine kinase inhibitor (TKI).
The findings were presented by Suresh Ramalingam, from the Winship Cancer Institute of Emory University in Atlanta, Georgia, USA, at the ESMO Congress 2019 in Barcelona, Spain, and add to the previously reported significant improvement seen with osimertinib in the primary endpoint of progression-free survival.
Ramalingam highlighted that osimertinib is the first EGFR–TKI to demonstrate a significant OS gain as a monotherapy versus another EGFR–TKI.
And he added that this final OS analysis of the phase III trial “reinforces osimertinib as the [front-line] standard of care” for this patient population.
Suresh Ramalingam presents the overall survival analysis of the FLAURA trial, and discusses the options after progression on the tyrosine kinase inhibitor (1:50).
Over a median follow-up of 35.8 months, the median OS duration was 38.6 months for the 279 participants with locally advanced or metastatic disease who were randomly assigned to receive osimertinib 80 mg/day. And it was 31.8 months for their 277 counterparts who instead received the comparator EGFR–TKI (erlotinib 150 mg/day or gefitinib 250 mg/day), for whom the median follow-up was 27.0 months. This translated into a significant hazard ratio for death of 0.799 in favor of osimertinib.
The OS rates for the osimertinib and control groups at 1, 2, and 3 years were 89% versus 83%, 74% versus 59%, and 54% versus 44%, respectively.
Ramalingam pointed out that the median OS observed in the comparator–TKI group is “among the highest recorded with erlotinib or gefitinib in this patient population, and we believe this is attributable to the crossover of patients from the control group to receive osimertinib upon progression.”
He also shared data demonstrating the durability of the benefit afforded by osimertinib. At the 36-month mark, 28% of patients in the osimertinib group remained on treatment compared with 9% of those in the control group.
Osimertinib was also associated with a significantly longer time to subsequent therapy, at a median of 25.5 months versus 13.7 months for erlotinib or gefitinib.
The safety profile of osimertinib remained favorable with the longer follow-up and despite a longer median duration of exposure (20.7 vs 11.5 months for the control). The incidence of adverse events of at least grade 3 that were possibly attributable to treatment was 18% in the osimertinib group and 29% in the control group.
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ESMO Congress 2019; Barcelona, Spain: 27 September–1 October