Optune Lua (Electrical Current Therapy) Receives FDA Approval for Lung Cancer

On October 15, 2024, the Optune Lua device developed by Novocure received FDA (United States Food and Drug Administration) approval for use alongside immunotherapy or docetaxel. This second-line treatment approval applies to adult patients with metastatic non-small cell lung cancer (NSCLC) whose disease has progressed after platinum-based treatment and marks an important milestone. This wearable device delivers “tumor treating fields” (TTF = tumor treating fields), which cause cell death by applying physical forces to electrically charged components during cancer cell division.

What Are TTF? How Do They Work?

Tumor-treating fields (TTF) are a regional antimitotic cancer treatment device that delivers low-intensity alternating electric currents to the tumor. These alternating electric currents suppress spindle formation during the metaphase of  mitosis, thereby inhibiting cell division. This leads to immunogenic cell death and an enhanced antitumor immune response. The form of this treatment developed by Novocure is available in the United States, Canada, Japan, Germany, Israel, and many European countries. It is not yet available in Turkey.

NOTE: Novocure's Optune technology previously received FDA approval in 2015 for glioblastoma multiforme (GBM) and in 2019 for mesothelioma .

FDA Approval Based on the LUNAR Study

This approval is supported by data from the phase III LUNAR study, whose results were published in 2023 in Lancet Oncology . This randomized, open-label, multicenter study compared tumor treating fields alongside immunotherapy (PD-1/PD-L1 inhibitors) or docetaxel (the experimental arm) with a control group treated with PD-1/PD-L1 inhibitors or docetaxel alone. The study included patients with metastatic NSCLC whose disease had progressed during or after platinum-based treatment.

Improved Survival: A Meaningful Gain of 3.3 Months

The study successfully met its primary endpoint. Tumor treating fields alongside immunotherapy or docetaxel produced a significant 3.3-month improvement in median overall survival (P = 0.04) compared with immunotherapy or docetaxel alone. Median overall survival in the group receiving tumor treating fields was 13.2 months (95% confidence interval [CI] = 10.3–15.5 months), compared with 9.9 months (95% CI = 8.2–12.2 months) in the group receiving immunotherapy or docetaxel alone.

Secondary Endpoints: An 8-Month Advantage When Used Alongside a PD-1/PD-L1 Inhibitor

The LUNAR study also included two prespecified secondary endpoints. The first showed a statistically significant improvement in survival with tumor treating fields alongside immunotherapy compared with immunotherapy alone. The second showed a favorable trend with tumor treating fields alongside docetaxel compared with docetaxel alone, but the difference was not statistically significant.

Patients receiving tumor treating fields alongside immunotherapy (70 patients) achieved a median overall survival of 19 months (95% CI = 10.6–28.2 months), compared with patients receiving immunotherapy alone (71 patients), whose median survival was 10.8 months (95% CI = 8.3–17.6 months). This produced a difference of more than 8 months in survival, which was statistically significant (P = 0.02). In patients receiving tumor treating fields alongside docetaxel (75 patients), median overall survival was 11.1 months (95% CI = 8.2–13.9 months), compared with 8.9 months (95% CI = 6.5–11.3 months) in those receiving docetaxel alone (75 patients). Although this 2.2-month improvement was not statistically significant, it showed a favorable trend.

Adverse Effects and Safety Profile

Device-related adverse effects, mainly skin disorders at the application sites, occurred in 63.1% of patients (89 patients). Most were grade 1 or 2, but grade 3 skin toxicity requiring a treatment interruption occurred in 4% (6 patients). No grade 4 or 5 toxicity or treatment-related deaths associated with tumor treating fields therapy were reported.

Patient Characteristics

Baseline patient characteristics were balanced between the two groups. The median age was 65 (range, 22–86 years); 66% were men, and 96% had a performance status of 0 or 1 (Eastern Cooperative Oncology Group [ECOG]). PD-L1 expression data were collected from 83% of patients enrolled at centers in the United States, and this proportion was balanced across the four cohorts.

This approval should be regarded as an important step in the treatment of metastatic non-small cell lung cancer, offering new hope, particularly for patients whose disease is progressing.