AstraZeneca's Tagrisso beats standard of care in halting NSCLC

AstraZeneca has revealed new data at the European Society of Medical Oncology (ESMO) on the efficacy of Tagrisso (osimertinib) in the first-line treatment of epidermal growth factor receptor (EGFR)-mutated non-small-cell lung cancer (NSCLC) in adult patients. Compared to the current standard of therapy – erlotinib, manufactured by Roche and Astellas, orAstraZeneca’s own Iressa (gefitinib) – Tagrisso was found to extend progression-free survival (PFS) by 54%.

The EGFR tyrosine kinase inhibitor met its primary endpoint of PFS across the 556-participant study, producing a median PFS of 18.9 months compared to 10.2 months for standard of care. Tagrisso also achieved a median duration of response of 17.2 months compared to 8.5 months, while median objective response rate stood at 80% compared to 76%.

The company stated that these findings "were consistent across all pre-specified patient subgroups, with at least a 40% reduction in the risk of progression or death, including in patients with or without central nervous system metastases at study entry."

Sean Bohen, Chief Medical Officer at AstraZeneca, added: "the FLAURA data suggest early and sustained benefit with Tagrisso that has the potential to significantly impact long-term patient outcomes and help address the considerable unmet need that remains."

The company has said that it is currently in conversation with global regulatory bodies concerning market applications for Tagrisso supported by these new data. The drug has already received approval in the US and Europe for the treatment of advanced EGFR T790M mutation-positive NSCLC in patients whose condition has worsened following use of an EGFR TKI. Analyst estimates predict that the therapy could generate around $3.8 million for the company by 2023.