Positive high-level results from the final overall survival (OS) analysis of the FLAURA2 Phase III trial showed AstraZeneca’s Tagrisso (osimertinib) with the addition of pemetrexed and platinum-based chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint of OS compared to Tagrisso monotherapy for patients with 1st-line locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).

The final OS analysis demonstrates consistent survival benefit as previously reported in the interim OS results, and builds on the previously presented primary endpoint data, which demonstrated the longest-reported median progression-free survival (PFS) in this setting.

Pasi A. Jänne, MD, PhD, Senior Vice President for Translational Medicine and thoracic medical oncologist at Dana-Farber Cancer Institute and principal investigator for the FLAURA2 trial, said: “When treating lung cancer, the aim is to both prolong survival and improve the patient experience, especially in 1st-line where treatment duration can be long and many patients remain active. These positive results support osimertinib, either as monotherapy or in combination with chemotherapy, as standard of care for patients with 1st-line advanced EGFR-mutated lung cancer and reinforce the meaningful benefit of the combination in the current clinical setting. The observed survival benefit is particularly impressive given that FLAURA2 did not impose any restrictions on the choice of subsequent treatment after disease progression.”

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “These exciting overall survival results add to the extensive evidence supporting Tagrisso as the backbone therapy in EGFR-mutated lung cancer, demonstrating that Tagrisso plus chemotherapy can significantly extend survival in the 1st-line advanced setting, in addition to prior trials showing survival benefits as monotherapy in both early stage and advanced disease. With its strong survival benefit and tolerable safety profile, this combination has the potential to help patients live longer while maintaining their quality of life on treatment.”

With longer follow up, the safety profile of Tagrisso plus chemotherapy continues to be manageable and consistent with the established profiles of the individual medicines. Adverse event (AE) rates were higher in the Tagrisso plus chemotherapy arm, driven by well-characterised chemotherapy-related AEs. Discontinuation rates due to AEs and on-target toxicities were low in both arms of the trial.

Tagrisso plus chemotherapy is approved in more than 80 countries, including the US, EU, China and Japan, based on the FLAURA2 Phase III trial.