A plain language summary of results from the FLAURA2 study: Initial (first-line) osimertinib treatment with or without chemotherapy in patients with untreated EGFR-mutated advanced NSCLC

Future Oncol. 2025 Apr;21(8):903-915. doi: 10.1080/14796694.2025.2463880. Epub 2025 Feb 24.
No abstract available

Plain language summary

What was the purpose of the FLAURA2 study?This is a summary of the main results of 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 is the most common type of lung cancer, but is often not diagnosed until the cancer has spread beyond the lungs described as ‘metastastic’ or ‘advanced’ disease.Epidermal growth factor (EGF) binds to the EGFR (epidermal growth factor receptor) and leads to signaling events that control how cells grow and divide.Healthy cells transform into cancer cells when changes (mutations) occur in the EGFR gene, in NSCLC this is known as 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, but when osimertinib stops working, chemotherapy is usually recommended as the next treatment. However, many patients with EGFR-mutated NSCLC do not receive another treatment after first-line osimertinib, mainly because their health has become too poor. This means that it is important to make sure the best treatment is given first. The FLAURA2 study assessed whether adding chemotherapy to osimertinib as first-line treatment for patients with EGFR-mutated advanced NSCLC could extend the time before cancer cells grew/spread,or prolong the time before patients died.What were the results?In the FLAURA2 study, patients with EGFR-mutated advanced NSCLC received first-line treatment consisting of either chemotherapy (a platinum drug plus pemetrexed) added to osimertinib, or osimertinib alone. Osimertinib plus chemotherapy extended the time from when patients were assigned a treatment until the cancer grew/spread, or until death, compared with osimertinib alone.What do the results of the study mean?The results show that addition of chemotherapy to first-line osimertinib could be beneficial for patients with EGFR-mutated advanced NSCLC. Side effects of the combination were similar to those of either chemotherapy or osimertinib alone, and the combination was considered tolerable. The findings led to osimertinib plus chemotherapy being approved in a number of countries, including China, Japan, the USA, and the European Union, as a new first-line treatment option. The FLAURA2 study is ongoing, and more results are expected to be released in the future.[Box: see text].