- Optune Lua® receives CE Mark approval for metastatic non-small cell lung cancer (NSCLC) treatment.
- Phase 3 LUNAR trial shows significant survival benefit with Optune Lua.
- Novocure (NVCR, Financial) prepares for Optune Lua launch in Europe following FDA approval in the U.S.
Novocure (NVCR) announced that its innovative cancer treatment device, Optune Lua®, has been granted CE Mark approval for treating adult patients with metastatic non-small cell lung cancer (NSCLC) in Europe. This approval allows the device to be used concurrently with immune checkpoint inhibitors or docetaxel in patients who have progressed on or after a platinum-based regimen.
The CE Mark approval was supported by data from the Phase 3 LUNAR trial, which demonstrated a significant improvement in median overall survival (OS). Specifically, patients receiving Optune Lua in combination with an immune checkpoint inhibitor or docetaxel experienced a 3.3-month extension in median OS compared to those receiving standard therapies alone, showing 13.2 months versus 9.9 months. A subset of patients receiving Optune Lua and immune checkpoint inhibitors saw a remarkable 7.7-month extension in median OS.
Optune Lua is a groundbreaking, wearable medical device that delivers Tumor Treating Fields (TTFields)—alternating electric fields that target and kill cancer cells by disrupting their division. The device provides a promising new treatment option for patients with few alternatives, offering significant efficacy without systemic toxicity.
Frank Leonard, President of Novocure Oncology, expressed optimism, stating that the approval represents a significant milestone in transforming the treatment landscape for late-stage lung cancer. Novocure is now moving forward with local registration requirements in Germany and anticipates launching Optune Lua across Europe in the coming weeks.
According to the trial data, skin-related disorders were the most common device-related adverse events, occurring in 65.4% of patients, with the majority being low-grade. No severe toxicities (Grade 4 or 5) were reported, underscoring the device's safety profile.
Following its approval in Europe and prior approval by the U.S. FDA in October 2024, Novocure will conduct a post-market study to further assess Optune Lua's effectiveness in a routine care setting for metastatic NSCLC.
