AstraZeneca announces positive results from phase 3 trial for Tagrisso plus chemotherapy
AstraZeneca has announced positive results from the FLAURA2 phase 3 trial, which showed that Tagrisso (osimertinib), in combination with chemotherapy, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) when compared to Tagrisso alone in the treatment of patients with locally advanced (stage IIIB-IIIC) or metastatic (stage IV) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).
The drug’s safety results and discontinuation rates due to adverse events remained consistent with previously established profiles of the medicine.
Full data from the trial is expected to be presented at a forthcoming medical meeting, after which it will be shared with global health authorities.
Pasi A Jänne MD PhD, medical oncologist at Dana-Farber Cancer Institute and principal investigator for the FLAURA2 trial, commented: “As the global standard of care for EGFR-mutated non-smallcelllungcancer,osimertinibmonotherapy has transformed the treatment landscape allowing many patients the opportunity to achieve improved survival. FLAURA2 provides compelling evidence that the addition of chemotherapy to osimertinib can provide a new option for patients and clinicians that further improves outcomes compared to osimertinib alone and as such, can further delay treatment resistance and disease progression.”
Susan Galbraith, executive vice president of Oncology R&D at AstraZeneca, added: “These significant FLAURA2 results show Tagrisso has the potential to offer patients in the first-line setting a new treatment option that can extend the time they live without their disease progressing. This meaningfully builds on successive trials which have demonstrated improved clinical benefit with Tagrisso in patients with EGFR-mutated lung cancer.”