AstraZeneca (AZ) has shared positive results from a late-stage trial evaluating Tagrisso (osimertinib) alongside chemotherapy in a subset of advanced lung cancer patients.
The epidermal growth factor receptor-mutated (EGFR)-tyrosine kinase inhibitor was approved by the US Food and Drug Administration last month for use alongside chemotherapy in adults with locally advanced or metastatic EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC).
The regulator’s decision was supported by positive progression-free survival results from the phase 3 FLAURA2 trial, which randomised more than 500 patients with locally advanced or metastatic EGFRm NSCLC to receive the Tagrisso/chemotherapy combination or Tagrisso alone.
An estimated 2.4 million people globally are diagnosed with lung cancer each year, with NSCLC accounting for up to 85% of all cases.
Up to 15% of NSCLC patients in the US and Europe have an EGFRm, a population that is particularly sensitive to treatment with an EGFR-tyrosine kinase inhibitor that blocks the cell-signalling pathways that drive the growth of tumour cells.
According to new results from FLAURA2 presented at this year’s European Lung Cancer Congress, the Tagrisso combination demonstrated a favourable trend toward overall survival improvement at two years of follow up. This was consistent across pre-specified subgroups, including type of EGFR mutation and age at the time of diagnosis.
AZ noted that the overall data was not statistically significant at the interim analysis and will continue to be assessed as a key secondary endpoint.
Tagrisso, with the addition of chemotherapy, also showed a consistent benefit across the trial’s pre-specified post-progression endpoints of time to first subsequent treatment, time to progression on second-line therapy and time to second subsequent treatment.
Commenting on the latest readout, Susan Galbraith, executive vice president, oncology research and development at AZ, said: “FLAURA2 reinforces Tagrisso as the backbone therapy in EGFRm NSCLC either as a monotherapy or in combination with chemotherapy, delivering the longest reported progression-free survival benefit in the first-line advanced setting.
“We’re excited to see a favourable trend toward overall survival and look forward to seeing this data mature over time.”
Tagrisso is already approved as monotherapy in more than 100 countries, with indications including for first-line treatment of patients with locally advanced or metastatic EGFRm NSCLC, locally advanced or metastatic EGFR T790M mutation-positive NSCLC and adjuvant treatment of early-stage EGFRm NSCLC.