AstraZeneca has presented new data showing that Tagrisso also extends progression-free survival for non-small cell lung cancer (NSCLC) patients who have central nervous system (CNS) metastases.
According to findings from the AURA3 trial, patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive NSCLC given the drug lived without disease worsening or death for 11.7 months compared to 5.6 months for those receiving chemotherapy.
Among patients evaluable for response, the CNS objective response rate (ORR) was 70 percent with Tagrisso (osimertinib) and 31 percent with chemotherapy. Also, the adverse event profiles for the drug and platinum-based doublet chemotherapy were consistent with previous trials.
“These data suggest that, like the overall EGFRm T790M mutation-positive NSCLC population, patients who have progressed to develop CNS metastases may also be able to benefit from osimertinib,” said Dr Marina-Chiara Garassino, the Thoracic Oncology Unit, Medical Oncology Department Fondazione IRCCS Istituto Nazionale dei Tumori, Milan.
Tagrisso is a third generation, irreversible EGFR tyrosine kinase inhibitor designed to inhibit both EGFR sensitising and EGFR T790M resistance mutations and to have activity in the CNS.
The drug won full European approval earlier this year for EGFR T790M-positive advanced NSCLC after becoming the first drug to win conditional clearance in the region in February 2016.
Almost two-thirds of NSCLC patients who are EGFR mutation-positive and experience disease progression after being treated with an EGFR-TKI develop the T790M resistance mutation, for which there have been limited treatment options to date, AZ said at the time, highlighting the drug’s potential scope.