Novocure’s Optune Lua® Gets CE Mark for mNSCLC Treatment
Novocure (NASDAQ: NVCR) has announced that its Optune Lua® device has received the CE Mark (Conformité Européenne) for treating adult patients with metastatic non-small cell lung cancer (mNSCLC) who are undergoing immune checkpoint inhibitors or docetaxel treatment after progressing on platinum-based therapy. This marks a significant step forward in the treatment of mNSCLC, an aggressive cancer with limited treatment options.
Dr. Joachim Aerts, a key physician involved in the LUNAR study and a Professor of Pulmonary Oncology at the Erasmus MC Cancer Institute, emphasized the importance of Optune Lua, calling it an urgently needed new approach for treating this challenging form of cancer. He highlighted that the Phase 3 LUNAR study was the first in over eight years to show a significant improvement in overall survival (OS) for patients with this aggressive cancer, all while avoiding the systemic toxicity typically associated with conventional treatments.
Optune Lua is a wearable device that uses Tumor Treating Fields (TTFields), which are alternating electric fields delivered via non-invasive, wearable arrays. These fields exert physical forces on the electrically charged components of dividing cancer cells, leading to their death. The device offers a novel and non-toxic treatment option for patients with metastatic NSCLC, offering hope to those with limited therapeutic choices.
Frank Leonard, President of Novocure Oncology, celebrated the CE Mark as a major achievement in Novocure’s mission to improve outcomes for patients with difficult-to-treat cancers. He explained that TTFields therapy has already shown promise in treating several tough tumor types, including lung cancer. The combination of efficacy and minimal systemic toxicity makes Optune Lua a revolutionary option for patients with late-stage lung cancer.
The CE Mark approval comes after Novocure initiated local regulatory approval for Optune Lua in Germany and is preparing for its market launch in the coming weeks. This follows the U.S. Food and Drug Administration’s approval of the device in October 2024.
Data Supporting CE Marking
The CE Mark for Optune Lua was supported by data from the Phase 3 LUNAR trial, which compared the safety and efficacy of treatment with Optune Lua plus immune checkpoint inhibitors or docetaxel against immune checkpoint inhibitors or docetaxel alone in patients with mNSCLC who had progressed after platinum-based therapy.
The trial met its primary endpoint, demonstrating a statistically significant and clinically relevant improvement in overall survival. Patients treated with Optune Lua combined with either immune checkpoint inhibitors or docetaxel had a median overall survival (OS) of 13.2 months, compared to 9.9 months for those receiving immune checkpoint inhibitors or docetaxel alone. This represented a 3.3-month improvement in median OS (P = 0.035).
In the subgroup of patients receiving Optune Lua with immune checkpoint inhibitors, the OS improved by 7.7 months, with a median OS of 18.5 months compared to 10.8 months for those receiving immune checkpoint inhibitors alone (P = 0.03). The group receiving Optune Lua with docetaxel showed a 2.4-month improvement in OS, though this result did not reach statistical significance.
Regarding safety, device-related adverse events (AEs) were mostly mild and involved skin irritation around the transducer arrays in 65.4% of patients. Only 5% of patients experienced Grade 3 skin changes requiring treatment interruption. No Grade 4 or 5 adverse events were reported, and no device-related AEs resulted in death.
As a condition for CE Mark approval, Novocure will conduct a post-market study to assess the efficacy of TTFields in combination with docetaxel in routine care. This study will involve 180 patients and will compare their outcomes with a control group receiving docetaxel alone.
Lung Cancer and Treatment Landscape
Lung cancer remains the leading cause of cancer-related death in the EU, with NSCLC accounting for about 85% of all lung cancer cases. Approximately 400,000 new cases of NSCLC are diagnosed annually in Europe. Treatment for NSCLC involves surgery, radiation, and a variety of drug therapies depending on the cancer stage. Immune checkpoint inhibitors, including PD-1 and PD-L1 inhibitors, are commonly used as first-line therapies, with platinum-based chemotherapy remaining the standard second-line treatment for many patients.
The approval of Optune Lua marks a breakthrough in the second-line treatment of mNSCLC, offering a new approach to a patient group facing limited options.
About Tumor Treating Fields (TTFields)
Tumor Treating Fields (TTFields) are alternating electric fields that work by exerting physical forces on cancer cells, disrupting their division and leading to cell death. These fields have been shown to have no significant effects on healthy cells, which differ from cancer cells in their properties. TTFields have demonstrated enhanced efficacy in several solid tumor types, particularly when combined with chemotherapy, radiotherapy, or immune checkpoint inhibitors. The treatment’s versatility allows it to address challenges in various solid tumors, providing a unique opportunity for late-stage cancer patients.
