Novocure announces data from the randomized phase 3 LUNAR clinical trial

Novocure announced that data from the randomized phase 3 LUNAR clinical trial evaluating the use of Tumor Treating Fields, or 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 when TTFields therapy was added to physician’s choice of immune checkpoint inhibitor, or ICI, or docetaxel. 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. Patients randomized to receive TTFields therapy together with standard therapies demonstrated median OS of 13.2 months compared to 9.9 months in patients treated with standard therapies alone. Patients randomized to receive TTFields therapy and physician’s choice ICI demonstrated a median OS of 18.5 months versus a median OS of 10.8 months in patients treated with an ICI alone. Patients randomized to receive TTFields therapy and docetaxel had a positive survival trend with a median OS of 11.1 months vs 8.7 months in patients treated with docetaxel alone. TTFields therapy was well-tolerated with no added systemic toxicities and few grade 3 device-related adverse events. The LUNAR clinical trial data are expected to serve as the basis for a Premarket Approval submission to theFDA in the second half of 2023. Novocure recently completed the LUNAR submission for CE mark.