Suresh S. Ramalingam, MD @RamalingamMD of @WinshipAtEmory illustrates the next step in the phase III FLAURA trial in NSCLC.
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28% of patients in the global FLAURA trial were still receiving TAGRISSO at three years vs. 9% on either gefitinib or erlotinib
TAGRISSO showed a 52% reduction in risk of central nervous system disease progression or death
AstraZeneca today presented detailed overall survival (OS) results from the Phase III FLAURA trial of TAGRISSOรยฎ (osimertinib) in the 1st-line treatment of adult patients with locally-advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).
Results showed a statistically significant and clinically meaningful improvement in OS, a key secondary endpoint for TAGRISSO versus gefitinib or erlotinib, both of which were previous standard-of-care (SoC) treatments in this setting (HR 0.799 [95% CI, 0.641-0.997], p=0.0462).
TAGRISSO delivered a median OS of 38.6 months versus 31.8 months for the comparator arm. At three years, 28% of patients in the TAGRISSO arm and 9% of patients in the comparator arm remained on 1st-line study treatment. TAGRISSO also showed a statistically significant and clinically meaningful 52% reduction in the risk of central nervous system (CNS) disease progression, increasing the time patients with CNS metastases lived without CNS disease progression or death (HR 0.48 [95% CI, 0.26-0.86], p=0.014).1
The results were presented at the Presidential Symposium of the ESMO (European Society for Medical Oncology) 2019 Congress in Barcelona, Spain (Abstract #LBA5_PR).
Josรยฉ Baselga, Executive Vice President, Oncology R&D said: รขโฌลTAGRISSO has set a new benchmark in EGFR-mutated non-small cell lung cancer by demonstrating a median overall survival of more than three years. We have not before seen survival benefits of this magnitude in any global Phase III trial with any such therapy. The ground-breaking data reaffirm the benefit of using TAGRISSO first and further support its use as the 1st-line standard of care in this setting.รขโฌย
Dr. Suresh S. Ramalingam, Principal Investigator of the FLAURA trial from Winship Cancer Institute of Emory University, Atlanta, US, said: รขโฌลThe results of the FLAURA trial provide further evidence to support the role of osimertinib as the preferred 1st-line therapy option for patients with EGFR-mutated non-small cell lung cancer. It is highly noteworthy that 28% of patients are still being treated with 1st-line osimertinib at three years versus 9% on either gefitinib or erlotinib.รขโฌย