Treatment with third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) osimertinib resulted in a significantly improved overall survival compared with other EGFR-TKIs among patients with EGFR-mutated, advanced non-small cell lung cancer (NSCLC), according to final results from the FLAURA trial.

The phase 3 trial randomly assigned 556 patients with previously untreated disease to receive osimertinib 80 mg once daily or either gefitinib 250 mg once daily or erlotinib 150 mg once daily. Previously published results showed that osimertinib significantly prolonged progression-free survival. Overall survival was a secondary end point of the trial.

With a median follow-up of 38.6 months, patients assigned to receive osimertinib had almost a 7-month improvement in overall survival. The median overall survival for osimertinib was 38.6 months compared with 31.8 months for the other EGFR-TKIs (hazard ratio for death, 0.80; P =.046). This benefit was consistent across all subgroups examined.

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Rates of grade 3 or higher adverse events were similar across the treatment arms.

“Subsequent therapies that were received in each trial group were consistent with expectations on the basis of the treatment guidelines for this patient population,” the researchers wrote. “The majority of patients in the osimertinib group received chemotherapy as the first subsequent therapy, whereas crossover to osimertinib was the most common first subsequent therapy in the comparator group.”

Disclosure: This trial was supported by AstraZeneca. Some of the authors disclosed financial relationships with pharmaceutical and medical device companies. For a full list of disclosures, please refer to the original study.


Ramalingam SS, Vansteenkiste J, Planchard D, et al. Overall survival with osimertinib in untreated, EGFR-mutated advanced NSCLC. N Engl J Med.2019;DOI:10.1056/NEJMoa1913662.