Patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) receiving osimertinib showed clinically meaningful overall survival (OS) rates compared with NSCLC patients receiving gefitinib or erlotinib, according to recent research presented at the European Society for Medical Oncology (ESMO) meeting in Barcelona.

In the randomized, double-blinded, phase III FLAURA trial, 556 patients with NSCLC received oral osimertinib (Tagrisso; Astrazeneca) at a daily dose of 80 mg (279 patients), or EGFR-tyrosine kinase inhibitors (TKIs) gefitinib at a daily oral dose of 250 mg or erlotinib at a daily oral dose of 150 mg as first-line therapy (277 patients).

Lung cancer cells. Source: Getty

The median progression-free survival (PFS) was 18.9 months in patients taking Tagrisso (hazard ratio, 0.46; 95% CI, 0.37-0.57; P < .0001) compared with 10.2 months in patients taking gefitinib or erlotinib. A secondary outcome was overall survival (OS), and patients receiving Tagrisso had a significantly improvement of median OS of 38.6 months compared with 31.8 months in patients receiving gefitinib or erlotinib (HR, 0.46; 95% CI, 0.37-0.57; P < .0001).

“Tagrisso 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,” José Baselga, MD, PhD, executive vice president, Oncology R&D at Astrazeneca, stated in a press release. “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.” 

These results persisted, and at 3 years, 53.7% of patients had survived in the Tagrisso group compared with 44.1% of patients in the gefitinib or erlotinib group. In addition, 28.0% of patients in the Tagrisso group were still taking the medication as first-line therapy at 36 months compared with 9.4% of patients in the gefitinib or erlotinib group. In addition, Tagrisso also had a statistically and clinically meaningful effect on central nervous system (CNS) disease progression, with a 52% reduction in CNS disease progression (HR, 0.48; 95% CI, 0.26-0.86; P = .014).

“The 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,” Suresh S. Ramalingam, MD, from Winship Cancer Institute of Emory University in Atlanta, and principal investigator of the FLAURA trial, stated in a press release. “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.”