AstraZeneca has secured approval from the European Commission (EC) for its drug Tagrisso (osimertinib) to treat adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC).
The drug is indicated for patients whose tumours exhibit epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy (CRT).
Tagrisso is a third-generation, irreversible EGFR tyrosine kinase inhibitor (TKI) that has demonstrated clinical efficacy in NSCLC, including effectiveness against central nervous system metastases.
The drug is available in 40mg and 80mg once-daily oral tablet forms and has been utilised globally across various indications. AstraZeneca is actively investigating Tagrisso for patients at multiple stages of EGFRm NSCLC.
The EC approval follows a positive opinion from the Committee for Medicinal Products for Human Use and is based on findings from the LAURA Phase III trial, published in The New England Journal of Medicine.
The LAURA trial is a randomised, double-blind, placebo-controlled, multi-centre, global Phase III study involving patients with unresectable, Stage III EGFRm NSCLC whose disease has not progressed after definitive platinum-based CRT.
In the trial, patients received Tagrisso 80mg once-daily oral tablets until disease progression, unacceptable toxicity, or other discontinuation criteria were met. Patients in the placebo arm were offered Tagrisso upon progression.
The trial enrolled 216 patients across more than 145 centres in over 15 countries, including the US, Europe, South America, and Asia. The primary endpoint of the trial is progression-free survival (PFS), while overall survival (OS) is being assessed as a secondary endpoint.
Results from the trial indicated that Tagrisso reduced the risk of disease progression or death by 84% compared to placebo, with a hazard ratio of 0.16 (95% confidence interval 0.10-0.24; p<0.001) as determined by blinded independent central review.
The median PFS for patients treated with Tagrisso was 39.1 months, compared to 5.6 months for those receiving placebo. The OS results are still immature, and the trial will continue to evaluate OS as a secondary endpoint.
AstraZeneca oncology business unit executive vice president Dave Fredrickson said: “Tagrisso is now the first and only EGFR inhibitor and targeted treatment approved in the EU for locally advanced, unresectable lung cancer, providing a new standard of care to patients who have historically experienced early progression after chemoradiation therapy.
“The powerful results from the LAURA trial show Tagrisso improves outcomes for patients in the unresectable setting, reinforces the importance of timely EGFR testing and solidifies Tagrisso as the backbone therapy in EGFR-mutated non-small cell lung cancer.”
