AstraZeneca has unveiled results from the FLAURA2 Phase III trial, indicating a significant advancement in treating non-small cell lung cancer (NSCLC). The study focused on patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) NSCLC, 40% of whom had brain metastases at baseline. These findings were presented at the European Society for Medical Oncology (ESMO) Congress.
In this cohort, combining AstraZeneca’s Tagrisso (osimertinib) with chemotherapy led to a remarkable 42% improvement in central nervous system (CNS) progression-free survival (PFS) compared to Tagrisso alone. The addition of chemotherapy significantly reduced the risk of CNS disease progression or death, with 74% of patients on the combination therapy not experiencing CNS disease progression or death versus 54% on Tagrisso monotherapy. Moreover, 59% of patients treated with Tagrisso plus chemotherapy had complete responses in brain tumors, a remarkable outcome.
David Planchard, MD, Ph.D., principal investigator for the trial, emphasized the importance of these results, stating that Tagrisso’s ability to cross the blood-brain barrier and achieve complete responses in brain tumors offers hope to patients facing a typically poorer prognosis.
The safety profile of Tagrisso plus chemotherapy was generally manageable and consistent with the individual medicines’ established profiles. While adverse event rates were higher in the combination arm, Tagrisso discontinuation rates were low in both arms of the trial.
These findings are especially significant as Tagrisso with the addition of chemotherapy recently received Priority Review by the Food and Drug Administration (FDA) for 1st-line treatment of EGFRm NSCLC, based on positive PFS data from the FLAURA2 Phase III trial. The combination therapy was also granted a Breakthrough Therapy Designation from the FDA, indicating its potential to address a critical unmet need in treating lung cancer patients with brain metastases.
Lung cancer remains a leading cause of cancer-related deaths, with NSCLC being the most prevalent form. Patients with EGFRm NSCLC often benefit from EGFR-tyrosine kinase inhibitors (EGFR-TKIs). Tagrisso, a third-generation EGFR-TKI, has already demonstrated its clinical efficacy in treating NSCLC, including CNS metastases.
In the ongoing FLAURA2 Phase III trial, Tagrisso is administered with chemotherapy, offering a potential new treatment paradigm for EGFRm NSCLC patients. AstraZeneca continues to explore Tagrisso as a treatment for patients in various stages of EGFRm NSCLC, aiming to improve outcomes and expand the available options for this challenging cancer.
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