Lung cancer can be treated with small molecules formulated as pills as well as biological medications that are injected or infused, both as standalone treatments or as part of drug combinations. A wearable technology is the latest addition to the treatment mix. The FDA has approved a Novocure medical device that uses fields of electricity to kill cancer cells.
The regulatory decision announced after Tuesday’s market close covers the treatment of adults with metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on or after receiving platinum-based chemotherapy. Root, Switzerland-based Novocure will market the Class 3 medical device under the name Optune Lua.
Optune Lua produces alternating electrical fields that Novocure calls “Tumor Treating Fields,” or TTFields. Electrical signals from the portable device are delivered by wearable arrays placed directly on the skin. The company says these fields exert physical forces on the electrically charged components of dividing cancer cells, killing them. Healthy cells have different properties that are unaffected by TTFields, according to the company. The device is intended to be worn about 18 hours a day.
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FDA approval of Optune Lua in NSCLC covers use of the device alongside either a type of immunotherapy called a checkpoint inhibitor or the chemotherapy docetaxel, which is how it was tested in clinical trials. Phase 3 results showed this treatment combination met the main goal of achieving a statistically significant and clinically meaningful 3.3 month extension in median overall survival compared to cohorts that received either a checkpoint inhibitor or docetaxel. Preliminary results from this study were reported last year.
Looking at the specific cohorts, the Optune Lua and checkpoint inhibitor arm achieved median overall survival of 8 months more compared to treatment with a checkpoint inhibitor alone. The Optune Luna and docetaxel arm showed a median overall survival of 2 months longer than treatment with docetaxel alone, which is short of being statistically significant. Device-related adverse events, mostly skin-related problems under the electrodes, occurred in 63.1% of patients. These events were classified as mostly low grade and only 4% of study participants experienced a severe enough reaction to require a break from treatment.
[Paragraph added with additional analyst comments.] Leerink Partners analyst Jonathan Chang said in a research note that despite the statistically significant improvement against the main trial goal, the full data presentation was unclear how many patients had previously received treatment with a checkpoint inhibitor. That’s important because such therapies have since moved up the treatment hierarchy into the first-line setting. But Chang added that approval of the Novocure device was likely given the lower regulatory bar for medical device approvals compared to therapeutics. Novocure has an additional Phase 3 test underway evaluating Optune Lua and the Merck checkpoint inhibitor Keytruda as a first-line treatment for metastatic NSCLC.
In Novocure’s announcement of the approval, Dr. Ticiana Leal, the primary investigator in the LUNAR Phase 3 study, said NSCLC is an aggressive disease that will progress in most patients. At that point, there are limited treatment options in the second-line setting and beyond.
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“The overall survival results we observed with Optune Lua in the LUNAR study mark the first substantial improvement in more than eight 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,” said Leal, who is an associate professor and director of the thoracic oncology program at the Winship Cancer Institute of the Emory University School of Medicine.
Novocure’s TTFields first reached patients as a treatment for a rare type of brain cancer. In 2011, the FDA approved a device from the company developed to treat the recurrence of glioblastoma multiforme after treatment with chemotherapy. This device is now marketed as Optune Gio. In 2019, an earlier iteration of Optune Lua was approved under a humanitarian device exemption permitting the technology’s use as a treatment for malignant pleural mesothelioma, a cancer affecting the lining of the lungs. This rare cancer is associated with asbestos exposure. Approval in this indication covers cases that cannot be treated surgically.
Besides the FDA approvals in glioblastoma and mesothelioma, Novocure’s products have marketing authorizations for these indications in Europe, Canada, and Japan and certain other countries. Zai Lab holds rights to commercialize Novocure’s technologies in China, Hong Kong, Macau, and Taiwan.
In 2023, Novocure reported $509.3 million in revenue, down 5.3% from the previous year. Most of the revenue comes from sales of Optune Gio in the U.S., Germany, and Japan, the company said in its annual report. FDA approval in advanced NSCLC gives Novocure the opportunity to grow revenue by addressing a much more prevalent cancer. Leerink’s Chang said that while questions remain about the position of TTFields within the NSCLC treatment landscape, the firm believes the opportunity in this indication could still drive meaningful revenue for Novocure.
Growth opportunities could also come from expanding the approved uses of the technology. This past spring, Novocure reported positive data from a Phase 3 test of TTFields in patients whose NSCLC metastasized to the brain. Another Phase 3 test is evaluating the device together with chemotherapy as a treatment for pancreatic cancer; preliminary data are expected by the end of this year. A Phase 2 trial evaluating TTFields along with chemotherapy and the Roche immunotherapy Tecentriq is currently enrolling pancreatic cancer patients. This study is proceeding under a clinical trial collaboration with Roche. Separately, a fully enrolled Phase 3 clinical trial is evaluating TTFields alongside radiation and chemotherapy as a treatment for glioblastoma. Preliminary data from this study are expected in 2026.
“We acknowledge that there is clinical and regulatory risk for each of these opportunities, though also note that TTFields has a positive track record of successful trials and approvals and that positive data in any of these indications could meaningfully expand the opportunity for TTFields,” Chang said.
Photo by Novocure