PBR Staff Writer Published 16 April 2018
AstraZeneca said that Tagrisso (osimertinib) in a first line setting has shown significant progression-free survival (PFS) benefit that was preserved through subsequent lines of therapy in patients with epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC).
The findings come from a phase 3 trial called FLAURA which assessed the efficacy and safety of Tagrisso 80mg, administered orally daily at 80mg in comparison with 150mg daily oral dosage of standard-of-care EGFR tyrosine kinase inhibitors (TKIs), erlotinib or gefitinib.
The late-stage trial was carried out in patients with locally-advanced or metastatic EGFRm NSCLC, who were previously not treated for their condition.
The double-blinded and randomized trial was conducted in 556 patients in 29 countries.
AstraZeneca said that the progression-free survival (PFS) benefit shown by first line treatment of Tagrisso was sustained throughout post-progression outcome, compared to what was seen in patients treated with erlotinib or gefitinib.
As per the data, 49% of patients in the Tagrisso arm had stopped treatment compared to 77% of patient who discontinued treatment in the EGFR-TKI comparator arm. Furthermore, 29% in the Tagrisso arm went on to take subsequent treatment compared to 46% of patients who were treated with either of the EGFR TKIs.
The company said that the average time to first subsequent therapy or death in the Tagrisso arm was 23.5 months in comparison to 13.8 months shown by patients who were subjected to erlotinib or gefitinib.
AstraZeneca global medicines development executive vice president and chief medical officer Sean Bohen said: “The new analysis from the FLAURA trial shows that 1st-line treatment with Tagrisso has a sustained effect beyond subsequent therapy by almost halving the risk of a second progression or death.
“These findings build on the clinically-meaningful PFS benefit of Tagrisso and reinforce its potential as a new standard of care.”
According to AstraZeneca, Tagrisso has been designed to inhibit EGFR sensitizing and EGFR T790M resistance mutations. Through its mechanism, the third generation and irreversible EGFR-TKI helps to improve clinical activity against CNS metastases.
Tagrisso 40mg and 80mg once-daily oral tablets are indicated for the treatment of EGFR T790M mutation-positive advanced NSCLC in more than 75 countries including the US, European Union member states, China and Japan.
Image: AstraZeneca’s Tagrisso showed sustained effect beyond subsequent therapy in first line treatment of EGFRm NSCLC. Photo: courtesy of AstraZeneca.