AstraZeneca’s supplemental New Drug Application (sNDA) for Tagrisso (osimertinib) in combination with chemotherapy has been accepted and granted Priority Review in the US for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).
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The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance.
The sNDA is based on data from the FLAURA2 Phase III trial presented in a Presidential Symposium at the International Association for the Study of Lung Cancer (IASLC) 2023 World Conference on Lung Cancer (WCLC).
In the trial, Tagrisso in combination with chemotherapy reduced the risk of disease progression or death by 38% compared to Tagrisso monotherapy, the 1st-line global standard of care (based on a hazard ratio [HR] of 0.62; 95% confidence interval [CI] 0.49-0.79; p<0.0001).
By investigator assessment, the combination extended median PFS by 8.8 months versus Tagrisso alone. PFS results from blinded independent central review were consistent, showing Tagrisso plus chemotherapy extended median PFS by 9.5 months (based on HR of 0.62; 95% CI 0.48-0.80; p=0.0002).
Importantly, a clinically meaningful PFS benefit was observed across all prespecified subgroups, including patients with central nervous system metastases. In this group, the combination reduced the risk of disease progression or death by 53% compared to Tagrisso monotherapy (based on a HR of 0.47; 95% CI 0.33-0.66), extending median PFS by 11.1 months versus Tagrisso alone.
At the time of this analysis, the overall survival (OS) data were immature, however, a favourable trend was observed for Tagrisso plus chemotherapy. The trial continues to assess OS as a key secondary endpoint.
The safety profile of Tagrisso plus chemotherapy was generally manageable and consistent with the established profiles of the individual medicines. Adverse event rates were higher in the combination arm, driven by well-characterised chemotherapy-related adverse events. ■