Recent FDA approval of combined therapy for initial treatment of EGFR-mutated NSCLC

The good news
The FDA recently approved Osimertinib combined with chemotherapy for the initial treatment of advanced EGFR-mutated non-small cell lung cancer (NSCLC) based on the results of the FLAURA2 trial.

Why it’s important
Osimertinib, which is a newer generation oral inhibitor of EGFR, has improved the treatment of EGFR-mutated lung cancer but unfortunately it is not curative for most patients. FLAURA2 was a large, international trial that treated over five hundred patients with advanced EGFR-mutated NSCLC with Osimertinib alone or combined with chemotherapy. The patients treated with Osimertinib and chemotherapy had an 8-month significant improvement in control of their cancer (New England Journal of Medicine, Volume 389, pages 1935-48). The combination therapy also had more benefit in patients who had brain metastases at their first diagnosis. The treatment was also able to delay the spread of cancer to the brain in patients who did not initially have brain metastases (Journal of Clinical Oncology, Volume 42, pages 808-20).

What it means for patients
This represents the first trial to show a benefit for patients with EGFR-mutated NSCLC treated with the combination of Osimertinib and chemotherapy. Even though there was an improvement in control of the cancer the results of the trial are still early, and it is unclear whether this improvement will result in patients living longer. The combination treatment did have more side effects primarily related to the chemotherapy. This approach to treatment may not be for every patient. Treatment options and their potential risks and benefits should always be discussed with one’s physician.

What to watch for
As the results of the FLAURA2 trial mature, physicians should have a better idea as to which patients will benefit from this approach to treatment. This continues to be an active area for research and physicians/scientists are actively trying to improve outcomes through understanding the biology of lung cancer and developing novel approaches to treatment.