Novocure announced that data from the randomized phase 3 LUNAR clinical trial evaluating the use of Tumor Treating Fields (TTFields) therapy together with standard systemic therapies for the treatment of metastatic non-small cell lung cancer (NSCLC) following progression on or after platinum-based therapy have been published in The Lancet Oncology. As presented at the 2023 American Society of Clinical Oncology Annual Meeting, the LUNAR trial met its primary endpoint, showing a statistically significant and clinically meaningful 3-month improvement in median overall survival (OS) when TTFields therapy was added to physician's choice of immune checkpoint inhibitor (ICI) or docetaxel (HR: 0.74, P=0.035). The data demonstrate the efficacy and safety of TTFields therapy in this setting, with no systemic toxicities or new safety signals.
In addition, patient-reported data suggest there was no quality-of-life burden associated with adding TTFields therapy to standard therapy. The LUNAR clinical trial data are expected to serve as the basis for a Premarket Approval (PMA) submission to the U.S. Food and Drug Administration in the second half of 2023. Novocure recently completed the LUNAR submission for CE mark.