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Osimertinib extends OS in lung cancer subset
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Osimertinib significantly prolonged OS compared with previous standard-of-care first-line therapies for patients with locally advanced or metastatic, EGFR-mutated non-small cell lung cancer, according to the agent’s manufacturer.
Osimertinib (Tagrisso, AstraZeneca) — a third-generation, irreversible EGFR tyrosine kinase inhibitor — is already approved in the United States for first-line treatment of EGFR-mutated metastatic NSCLC. It is the only therapy to confer a significant OS benefit in this setting.
The randomized phase 3 FLAURA trial included 556 previously untreated patients with locally advanced or metastatic EGFR-mutated NSCLC. Researchers evaluated the efficacy and safety of osimertinib dosed at 80 mg once daily compared with standard oral EGFR TKI therapy — either erlotinib (Tarceva; Genentech, Astellas) dosed at 150 mg once daily, or gefitinib (Iressa, AstraZeneca) dosed at 250 mg once daily.
The double-blind, multicenter trial met its primary endpoint, demonstrating a statistically significant improvement in PFS with osimertinib.
OS served as a secondary endpoint. Full OS results will be presented at an upcoming medical meeting.
Osimertinib exhibited a safety profile consistent with that observed in prior studies.
“[These] positive results show that Tagrisso provides an unprecedented survival outcome versus previous standard-of-care epidermal growth factor receptor tyrosine kinase inhibitors, reaffirming Tagrisso as the first-line standard-of-care for EGFR-mutated metastatic non-small cell lung cancer,” José Baselga, MD, PhD, executive vice president for oncology research and development at AstraZeneca, said in the press release.