NMPA (China) approves Tagrisso (osimertinib) + chemotherapy for the 1st-line treatment of patients with epidermal growth factor receptor-mutated NSCLC whose tumours have exon 19 deletions or exon 21 (L858R) mutations

The approval by China’s National Medical Products Administration (NMPA) was based on the results from the FLAURA2 Phase III trial published in The New England Journal of Medicine (previously cited), and results from a prespecified exploratory subgroup analysis of efficacy and safety in Chinese patients, which was presented at the European Society for Medical Oncology (ESMO) Asia Congress 2023.

In the overall trial population, Tagrisso with the addition of chemotherapy reduced the risk of disease progression or death by 38% by investigator assessment compared to Tagrisso monotherapy, which is the 1st-line global standard of care (hazard ratio [HR] 0.62; 95% confidence interval [CI] 0.49-0.79; p<0.0001). median progression-free survival (pfs) was 25.5 months for patients treated with tagrisso plus chemotherapy, an 8.8-month improvement versus tagrisso monotherapy (16.7 months). pfs results by blinded independent central review (bicr) in the overall trial population were consistent with results by investigator assessment, showing 29.4 months median pfs with tagrisso plus chemotherapy, a 9.5-month improvement over tagrisso monotherapy (19.9 months) (hr 0.62; 95% ci 0.48-0.80; p="0.0002)."

While the overall survival (OS) remained immature at the second interim analysis (41% maturity), an encouraging trend towards an OS benefit was observed with Tagrisso plus chemotherapy versus Tagrisso alone (HR 0.75; 95% CI 0.57-0.97). The trial continues to assess OS as a key secondary endpoint.

Efficacy results from the China cohort of FLAURA2 were broadly consistent with the overall trial.