Positive results from the final overall survival analysis of the phase III FLAURA2 trial showed that osimertinib (a third-generation, irreversible EGFR tyrosine kinase inhibitor) with the addition of pemetrexed and platinum-based chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint of overall survival compared with osimertinib monotherapy for patients with locally advanced or metastatic EGFR-mutated non–small cell lung cancer (NSCLC) in the first-line setting.
The final overall survival analysis demonstrates consistent survival benefit, as previously reported in the interim overall survival results, and builds on the previously presented primary endpoint data, which demonstrated the longest-reported median progression-free survival in this setting with the regimen.
Pasi A. Jänne, MD, PhD, Senior Vice President for Translational Medicine and Thoracic Medical Oncologist at Dana-Farber Cancer Institute and principal investigator for the FLAURA2 trial, shared these comments: “When treating lung cancer, the aim is to both prolong survival and improve the patient experience, especially in [the first] line, where treatment duration can be long and many patients remain active. These positive results support osimertinib, either as monotherapy or in combination with chemotherapy, as standard of care for patients with first-line advanced EGFR-mutated lung cancer and reinforce the meaningful benefit of the combination in the current clinical setting. The observed survival benefit is particularly impressive given that FLAURA2 did not impose any restrictions on the choice of subsequent treatment after disease progression.”
With longer follow-up, the safety profile of osimertinib plus chemotherapy continued to be manageable and consistent with the established profiles of the individual medicines. Adverse event rates were higher in the osimertinib plus chemotherapy arm, driven by well-characterized chemotherapy-related adverse events. Discontinuation rates because of adverse events and on-target toxicities were low in both arms of the trial.
These data will be presented at a forthcoming medical meeting and shared with global regulatory authorities, according to a press release from AstraZeneca, the manufacturer of osimertinib.
Osimertinib plus chemotherapy has been approved in more than 80 countries—including the United States, European Union, China, and Japan—based on the results of the FLAURA2 trial.
