Optune Lua Receives CE Mark in Europe for Metastatic NSCLC

Optune Lua received a CE Mark for metastatic NSCLC with immune checkpoint inhibitors or docetaxel: © appledesign - stock.adobe.com.

Optune Lua has received a Conformité Européenne (CE) Mark for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) concurrently with immune checkpoint inhibitors or docetaxel following progression on or after a platinum-based regimen, according to a recent announcement.

The regulatory development was announced in a news release issued by Novocure. Optune Lua, as explained in the news release, is a wearable medical device that delivers Tumor Treating Fields (TTFields), a means of treating metastatic non–small lung cancer via electric fields intended to kill cancer cells.

The CE Mark, as explained by the European Commission on its website, signifies that products sold in the European Economic Area (EEA) have been assessed to meet high safety, health and environmental protection requirements. With a CE Mark, a manufacturer is stating that a product meets all legal requirements for CE marking and can be sold throughout the EEA.

Novocure previously announced in October 2024 that Optune Lua had received approval in the United States from the Food and Drug Administration (FDA) for concurrent use with PD-1/PD-L1 inhibitors or docetaxel for adults with metastatic NSCLC who experienced progression on or after a platinum-based regimen.

As with the FDA approval, Optune Lua’s CE Mark approval was supported by findings from the phase 3 LUNAR trial. The study compared the safety and efficacy of treatment with Optune Lua administered concurrently with immune checkpoint inhibitors or docetaxel versus treatment with immune checkpoint inhibitors or docetaxel alone.

“Optune Lua is an innovative and urgently needed new approach for treating metastatic non-small cell lung cancer,” Dr. Joachim Aerts, a LUNAR investigator and professor of Pulmonary Oncology at Erasmus MC Cancer Institute in Rotterdam, the Netherlands, said in the news release. “There are few treatment options for people living with this aggressive cancer. In fact, the results from the phase 3 trial of Optune Lua were the first in more than eight years to show a treatment providing a significant extension in overall survival. These results and the lack of systemic toxicity observed with Optune Lua provide patients with a promising new treatment option.”

Patients on the LUNAR trial who were treated with Optune Lua concurrently with an immune checkpoint inhibitor or docetaxel experienced a 3.3-month extension in median overall survival, according to the news release. Patients also experienced a median overall survival time of 13.2 months versus 9.9 months among patients treated with an immune checkpoint inhibitor or docetaxel alone.

Furthermore, patients who received Optune Lua and an immune checkpoint inhibitor experienced an extension of 7.7 months in overall survival compared with those who received an immune checkpoint inhibitor alone, with median overall survival times of 18.5 months and 10.8 months, respectively.

Additionally, patients who were treated with Optune Lua and docetaxel saw a median overall survival time of 11.1 months versus 8.7 months among patients treated with docetaxel alone. This 2.4-month extension was not statistically significant but showed a positive trend, according to the news release.

Regarding safety, device-related side effects of skin-related disorders under the transducer arrays were experienced by 65.4% of patients, and the majority of these events were grade 1 (mild) or 2 (moderate), with 5% of patients experiencing a grade 3 (severe) skin event requiring a break from treatment.

“The CE Mark approval for Optune Lua for metastatic non-small cell lung cancer is a significant milestone in Novocure’s efforts to improve outcomes for people living with aggressive cancers,” said Frank Leonard, President, Novocure Oncology, in the news release. “Tumor Treating Fields therapy has demonstrated effectiveness in multiple tumor types that have historically been very difficult to treat, including lung cancer. We believe the efficacy Optune Lua can offer, paired with its lack of systemic toxicity, has the potential to change the way late-stage lung cancer is treated.”

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