A plain language summary of results from the FLAURA2 study: Effects of initial (first-line) osimertinib plus chemotherapy on the brain in patients with EGFR-mutated advanced non-small cell lung cancer

What was the purpose of the FLAURA2 study? This is a summary of results from the FLAURA2 clinical study in patients with EGFR-mutated, advanced non-small cell lung cancer (NSCLC). The results were published in full in 2023. NSCLC represents 85% of lung cancer cases, but is often not diagnosed until the cancer has spread beyond the lungs, known as ‘metastatic’ or ‘advanced disease’.EGFR(‘epidermal growth factor receptor’) controls how cells grow and divide.Changes (mutations) in the EGFR gene alter the EGFR-receptor, transforming healthy cells into cancer cells, as occurs in EGFR-mutated NSCLC. Osimertinib (TAGRISSO®) is a drug that has already been shown to treat EGFR-mutated NSCLC by blocking the effects of mutated EGFR, and preventing, slowing or stopping the growth of cancer cells. Osimertinib is approved and recommended by international treatment guidelines as initial (first-line) treatment for EGFR-mutated advanced NSCLC. EGFR-mutated NSCLC is particularly prone to spreading to the brain or spinal cord (known as central nervous system [CNS] metastases). The FLAURA2 study assessed if adding chemotherapy to osimertinib treatment could improve outcomes for patients, compared to osimertinib alone. Patients with brain metastases could participate as long as they were asymptomatic (not experiencing symptoms because of the brain metastases) or the brain metastases had been treated and were stable (not increasing in size or getting worse). The primary findings of FLAURA2 were that osimertinib plus chemotherapy extended the time before NSCLC tumor growth/spread, or patient death compared to osimertinib alone. What were the results in patients with and without brain metastases? In patients with brain metastases before treatment, those who were treated with osimertinib plus chemotherapy had a lower risk of their brain tumors growing/spreading, or death compared with patients who received osimertinib alone. Of those without brain metastases before treatment, very few in either treatment group developed a brain metastasis during the study. What do the results of the study mean? Based on the primary results of FLAURA2, osimertinib plus chemotherapy was approved for first-line treatment of EGFR-mutated advanced NSCLC. At the time of publication the FLAURA2 study is ongoing; more results, including survival rates, are expected to be released in the future.