Novocure’s Optune Lua® Gains CE Mark for Metastatic Non-Small Cell Lung Cancer Treatment
Tuesday, April 22, 2025
Novocure has received CE Mark approval for its device, Optune Lua®, for use in treating adults with metastatic non-small cell lung cancer (NSCLC). This approval allows the therapy to be used alongside immune checkpoint inhibitors or docetaxel in patients whose disease has progressed during or after platinum-based treatments.
Optune Lua is a portable, wearable device that delivers Tumour Treating Fields (TTFields). These are low-intensity electric fields that interfere with cancer cell division, leading to cell death. The therapy is non-invasive and does not rely on traditional drug mechanisms.
The CE Mark approval is based on results from the Phase 3 LUNAR clinical trial, which assessed the safety and effectiveness of Optune Lua used in combination with immune checkpoint inhibitors or docetaxel. The trial involved patients with metastatic NSCLC who had previously been treated with platinum-based chemotherapy.
The study achieved its main goal of showing improved overall survival. Patients who received Optune Lua along with either immune checkpoint inhibitors or docetaxel had a median overall survival of 13.2 months, compared to 9.9 months for those treated with immune checkpoint inhibitors or docetaxel alone.
Further analysis showed that patients treated with Optune Lua and immune checkpoint inhibitors had a median overall survival of 18.5 months, compared to 10.8 months for those who received immune checkpoint inhibitors alone. Those treated with Optune Lua and docetaxel had a median survival of 11.1 months, versus 8.7 months with docetaxel alone, though this difference was not statistically significant.
The majority of side effects were mild to moderate and related to skin irritation under the device’s transducer arrays. Severe skin reactions (Grade 3) were seen in around 5% of patients, but no life-threatening events or treatment-related deaths were reported.
Following CE Mark approval, Novocure has started local registration processes in Germany and plans to launch the device in the near future. This approval follows earlier clearance of Optune Lua by the U.S. Food and Drug Administration in October 2024.
As part of the CE Mark requirements, Novocure will run a post-market study to further assess overall survival in real-world settings. This study will involve 180 patients receiving TTFields therapy alongside docetaxel, with outcomes compared to a matched control group receiving docetaxel alone.
Optune Lua previously received CE Mark clearance for use with pemetrexed in treating patients with stage IV non-squamous NSCLC who had not responded to first-line treatment.
Lung cancer remains the leading cause of cancer-related deaths across the European Union, with NSCLC accounting for around 85% of cases. Over 400,000 new NSCLC cases are reported each year in Europe.
Treatment strategies for NSCLC typically include surgery, radiation, and drug-based therapies. Immune checkpoint inhibitors such as PD-1 and PD-L1 inhibitors are commonly used in early treatment stages, while second-line therapies may include platinum-based chemotherapy, pemetrexed, docetaxel, or targeted therapies.
TTFields therapy offers a new approach by using physical forces to target cancer cells while sparing healthy cells. Its mechanism allows it to be combined with other treatment types, showing potential for broader use across various solid tumours.
Source: businesswire.com
