pharmatimesJuly 17, 2018
Tag: Tagrisso , AstraZeneca , Osimertinib , lung cancer
According to new analysis of data from the global Phase III FLAURA trial, which assessed the efficacy and safety of Tagrisso (osimertinib) as a first-line of attack in patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC), the drug’s progression-free survival (PFS) benefit over the EGFR tyrosine kinase inhibitors (TKIs), erlotinib or gefitinib, was sustained throughout post-progression outcomes.
At the time of data cut-off, fewer patients in the Tagrisso group had discontinued treatment compared to those in the EGFR-TKI comparator arm (49 percent vs. 77 percent) and 29 percent versus 46 percent received a subsequent treatment, respectively.
Median time to first subsequent therapy or death was 23.5 months for those treated with first-line Tagrisso versus 13.8 months for patients taking erlotinib or gefitinib.
Also, first-line Tagrisso patients had almost half the risk of second progression or death compared to the comparator arm, the firm noted.
"The new analysis from the FLAURA trial shows that first-line treatment with Tagrisso has a sustained effect beyond subsequent therapy by almost halving the risk of a second progression or death," commented Sean Bohen, AZ’ chief medical officer. "These findings build on the clinically-meaningful PFS benefit of Tagrisso and reinforce its potential as a new standard of care."
The analysis was presented at the European Lung Cancer Conference (ELCC) in Geneva.
Tagrisso is a third generation, irreversible EGFR tyrosine kinase inhibitor designed to inhibit both EGFR sensitising and EGFR T790M resistance mutations and to have activity in the CNS.
The drug is already approved in several countries around the globe as a second-line treatment for patients with EGFR T790M mutation-positive advanced NSCLC, and is also under review on both sides of the Atlantic for use in the first-line setting.
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