FDA approves tumor treating fields as part of combination therapy for advanced lung cancer
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The FDA approved tumor treating fields for use as part of combination treatment for certain patients with metastatic non-small cell lung cancer.
The indication applies to use of Optune Lua (Novocure) with PD-1/PD-L1 inhibitors or docetaxel for adults whose disease progressed on or after a platinum-based regimen.
Optune Lua is a portable device that produces alternating electric fields known as tumor treating fields, according to a Novocure press release. These electric fields — delivered through wearable arrays — are designed to exert forces on electrically charged components of dividing cancer cells, leading to cell death, according to the release.
The FDA based approval on results of the randomized phase 3 LUNAR trial, which included patients with metastatic NSCLC who progressed during or after platinum-based therapy.
Researchers assigned patients to Optune Lua concurrent with PD-1/PD-L1 inhibitors or docetaxel, or PD-1/PD-L1 inhibitors or docetaxel alone.
OS served as the primary endpoint.
Results showed a statistically significant improvement in OS with the addition of concurrent Optune Lua (median, 13.2 months vs. 9.9 months; P = .04).
The study met a prespecified secondary endpoint, showing the addition of Optune Lua to PD-1/PD-L1 inhibitor therapy conferred a statistically significant improvement in OS (median, 19 months vs. 10.8 months; P = .02).
The addition of Optune Lua to docetaxel conferred a numerical improvement in OS (median, 11.1 months vs. 8.9 months) but the difference did not reach statistical significance.
About two-thirds (63.1%) of patients assigned to Optune Lua experienced device-related adverse events — specifically skin-related disorders under transducer arrays. Most events were grade 1 or grade 2. Six patients (4%) experienced grade 3 skin toxicity that necessitated a breast from treatment. No grade 4 or grade 5 device-related toxicities occurred.
“There have been a number of important advances in first-line treatment for NSCLC but this is an aggressive disease, and most patients will develop progression, with limited effective treatment options in second line and beyond,” Ticiana Leal, MD, primary investigator of the LUNAR study and director of the thoracic oncology program at Winship Cancer Institute of Emory University School of Medicine, said in a Novocure press release. “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.”
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