FDA Approves Tumor Treating Fields Wearable Device for Patients With Metastatic Non-Small Cell Lung Cancer

On October 15, 2024, the US Food and Drug Administration (FDA), approved the Optune Lua, a portable, wearable device that delivers Tumor Treating Fields (TTFields), for use with PD-1/PD-L1 inhibitors or docetaxel for patients with metastatic non-small cell lung (NSCLC), who have progress on or after treatment with a platinum-based regimen. This device was approved under the Human Device Exemption pathway.

TTFields are “electric fields that disrupt processes critical for cancer cell survival, leading to immunogenic cell death and enhanced antitumor immune response,” as explained by Ticiana Leal, MD, Winship Cancer Institute, Atlanta, Georgia, and coauthors. The open-label, phase 3 LUNAR trial, enrolled 276 patients with metastatic NSCLC who progressed on or after platinum-based therapy. Patients were randomly assigned on a 1-to-1 basis to receive either standard therapy with TTFields (n = 137), or standard therapy alone (n = 139). The standard systemic therapy consisted of investigator’s choice of immune checkpoint inhibitor from nivolumab, pembrolizumab, or atezolizumab; or docetaxel. TTFields were delivered continuously to the thoracic region, with the recommendation of reaching an average of at least 18 hours/day of device usage. The primary end point was overall survival (OS) in the intention-to-treat population.

With a median follow-up duration of 10.6 months for patients receiving TTFields and standard therapy, and 9.5 months for patients receiving standard therapy alone, the OS was significantly longer in the TTFields arm. The median OS in the TTFields arm was 13.2 months vs 9.9 months in the standard therapy alone arm (hazard ratio [HR], 0.74; 95% confidence interval [CI], 0.56 to 0.98; P = .035). In the safety population, consisting of 267 patients, serious adverse events of any cause were observed in 53% of 133 patients in the TTFields arm, and 38% of 134 patients in the standard therapy alone arm. Most frequent grade 3/4 adverse events were leukopenia, pneumonia, and anemia. There were 71% of patients with TTFields therapy-related adverse events. Most of these were grade 1/2 skin and subcutaneous tissue disorders. There were 3 deaths related to standard therapy (infection, n = 2; pulmonary hemorrhage, n = 1), and no deaths related to TTFields.

As Dr Leal et al stated, “TTFields therapy is efficacious in metastatic non-small cell lung cancer and should be considered as a treatment option to manage the disease in this setting.” Dr Leal later added, “The overall survival results we observed with Optune Lua in the LUNAR study mark the first substantial improvement in more than 8 years in this patient population which, when combined with Optune Lua’s lack of systemic toxicity, make this a compelling development for many patients and their physicians who need better treatment options for this advanced disease.”

Source:

Leal T, Kotecha R, Ramkau R, et al. Tumor Treating Fields therapy with standard systemic therapy versus standard systemic therapy alone in metastatic non-small-cell lung cancer following progression on or after platinum-based therapy (LUNAR): a randomised, open-label, pivotal phase 3 study. Lancet Oncol. 2023;24(9):1002-1017. doi:10.1016/S1470-2045(23)00344-3

Novocure. FDA Approves Novocure’s Optune Lua® for the Treatment of Metastatic Non-Small Cell Lung Cancer. Accessed October 17, 2024. https://www.novocure.com/fda-approves-novocures-optune-lua-for-the-treatment-of-metastatic-non-small-cell-lung-cancer