Novocure announced today that its Optune Lua device has received CE Mark approval for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC). The approval specifically covers use of the device concurrently with immune checkpoint inhibitors or docetaxel in patients who have progressed on or after a platinum-based regimen.
The portable, wearable device generates Tumor Treating Fields (TTFields), alternating electric fields delivered through non-invasive arrays that exert physical forces on electrically charged components of dividing cancer cells, resulting in cell death while largely sparing healthy cells.
This European approval follows the U.S. Food and Drug Administration's clearance of Optune Lua in October 2024 and represents a significant advancement in treatment options for patients with advanced lung cancer.
Significant Survival Benefits Demonstrated
The CE Mark approval was supported by data from the Phase 3 LUNAR trial, which showed patients treated with Optune Lua concurrently with an immune checkpoint inhibitor or docetaxel demonstrated a statistically significant 3.3-month extension in median overall survival (13.2 months vs. 9.9 months, p=0.035) compared to those receiving standard therapy alone.
Most notably, patients randomized to Optune Lua plus an immune checkpoint inhibitor experienced a remarkable 7.7-month extension in median overall survival compared to those treated with an immune checkpoint inhibitor alone (18.5 months vs. 10.8 months, p=0.03).
"Optune Lua is an innovative and urgently needed new approach for treating metastatic non-small cell lung cancer," said Joachim Aerts, M.D., a LUNAR investigator and Professor of Pulmonary Oncology at Erasmus MC Cancer Institute. "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."
Safety Profile and Implementation
The device demonstrated a favorable safety profile with primarily low-grade skin-related disorders under the transducer arrays occurring in 65.4% of patients. Only 5% experienced Grade 3 skin events requiring treatment interruption, with no Grade 4 or 5 toxicities related to the device.
Frank Leonard, President of Novocure Oncology, emphasized the significance of the approval: "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."
Novocure has initiated local registration requirements in Germany and is preparing for commercial launch in the coming weeks. As a condition of receiving the CE Mark, the company will conduct a post-market study of TTFields with docetaxel in 180 patients with metastatic NSCLC to further assess overall survival in routine clinical settings.
Addressing a Significant Unmet Need
Lung cancer remains the most common cause of cancer-related death in the European Union, with NSCLC accounting for approximately 85% of all lung cancers. More than 400,000 people are diagnosed with NSCLC in Europe each year.
The standard of care for second-line treatment of NSCLC continues to evolve and may include platinum-based chemotherapy for patients who received immune checkpoint inhibitors as their first-line regimen, as well as pemetrexed, docetaxel, immune checkpoint inhibitors, or anti-angiogenic therapies.
Optune Lua previously received CE Mark approval for the treatment of patients with stage IV, non-squamous NSCLC in combination with pemetrexed after failure of first-line treatments.
How Tumor Treating Fields Work
TTFields therapy represents a fundamentally different approach to cancer treatment. Unlike traditional therapies that rely on biochemical mechanisms, TTFields exert physical forces to disrupt cancer cell division through multiple mechanisms.
The technology selectively targets cancer cells because they have different properties than healthy cells, including division rate, morphology, and electrical characteristics. This multi-mechanistic action allows TTFields to be combined with other cancer treatments such as chemotherapy, radiotherapy, immunotherapy, or targeted therapies, potentially enhancing their effects.
This versatility makes TTFields a promising addition to the cancer treatment armamentarium, particularly for aggressive solid tumors that have historically been difficult to treat effectively.
With this latest approval, Novocure continues to expand the application of its innovative technology across multiple cancer types, offering new hope to patients with limited treatment options.
