AstraZeneca has reported positive data from the Phase III FLAURA2 trial of Tagrisso (osimertinib) along with chemotherapy in patients with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC).
The multi-centre, randomised, open-label, global Phase III trial is intended for the first-line treatment of 586 patients with locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) EGFRm NSCLC.
In the trial, the participants received treatment with Tagrisso 80mg once daily oral tablets along with chemotherapy (pemetrexed (500mg/m²) plus cisplatin (75mg/m²) or carboplatin (AUC5)) every three weeks for four cycles.
Later, they received Tagrisso with pemetrexed maintenance every three weeks.
According to the findings, the combination therapy showed improvement in progression-free survival (PFS) against Tagrisso alone.
The company stated that discontinuation rates and safety data due to adverse events were found to be in line with the established profiles of each medicine.
It also added that the trial is ongoing and will continue to evaluate the secondary endpoint of overall survival (OS).
AstraZeneca Oncology R&D executive vice-president Susan Galbraith said: “These significant FLAURA2 results show Tagrisso has the potential to offer patients in the first line setting a new treatment option that can extend the time they live without their disease progressing.
“This meaningfully builds on successive trials which have demonstrated improved clinical benefit with Tagrisso in patients with EGFR-mutated lung cancer.”
The company stated that Tagrisso is also being evaluated in the pivotal Phase III LAURA trial to treat unresectable NSCLC patients. It expects to obtain data from the trial later this year.