Non-Small Cell Lung Cancer Coverage from Every Angle

ESMO 2019: First-Line Osimertinib in Patients With EGFR-Mutated Advanced NSCLC

By: Joseph Fanelli
Posted: Monday, October 14, 2019

For patients with Ex19del/L858R EGFR-mutated advanced non–small cell lung cancer (NSCLC), the third-generation, oral EGFR tyrosine kinase inhibitor (TKI) osimertinib may improve and lengthen survival when compared with older generations of the treatment, according to the final overall survival analysis of the FLAURA, trial presented at the 2019 European Society for Medical Oncology (ESMO) Congress in Barcelona (Abstract LBA5_PR). Treatment with osimertinib, observed Suresh S. Ramalingam, MD, of the Winship Cancer Institute at Emory University, Atlanta, and colleagues, produced a “statistically significant and clinically meaningful” improvement in overall survival.

“This is the first time a TKI has proven to extend survival relative to another TKI in lung cancer therapy,” Dr. Ramalingam said in an ESMO press release. “Based on these data, osimertinib should be the preferred front-line therapy for EGFR-mutated lung cancer patients,” he added.

In this phase III trial, the authors enrolled 556 patients with Ex19del/L858R EGFR-mutated advanced NSCLC who had not undergone treatment. Of the enrolled, 279 received 80 mg of osimertinib daily, and 277 patients were treated with a comparator EGFR TKI. Patients who received a comparator EGFR TKI were permitted to cross over to osimertinib upon central confirmation of disease progression and detection of T790M-mutation positivity. Ultimately, 70 patients (25%) crossed over.

The authors reported a median overall survival of 38.6 months in those patients treated with osimertinib, compared with 31.8 months for those treated with first-generation EGFR TKIs (hazard ratio = 0.799). After 3 years, more than half (54%) of the patients treated with osimertinib were still alive, whereas 44% of the patients who received standard care were alive. As for toxicity, the safety profile appears to be consistent with previously reported data.

Disclosure: The study authors’ disclosure information may be found at

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