Combination therapies are a mainstay of cancer care, the idea being that treatments that work in different ways can together offer patients better and longer lasting effects. Scientists have successfully tested therapeutic pairings that include small molecules, antibodies, and engineered cytokines. Now we can add electricity to the list. Novocure has preliminary data from a pivotal study in lung cancer showing that treatment with its electrical field-producing medical device, in combination with standard treatments, helped patients live longer.
Without offering specifics, Novocure said Thursday that its technology met the main goal of a Phase 3 clinical trial, “demonstrating a statistically significant and clinically meaningful improvement in overall survival over standard therapies alone.” Based on the results from the study, Root, Switzerland-based Novocure said it plans to seek regulatory approvals in the U.S. and Europe in the second half of this year.
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There are many ways drugs kill cancer cells. Small molecules and antibodies can block proteins key to a cancer cell’s growth and survival. Immunotherapies can marshal the immune system to destroy tumors. Novocure’s approach employs physics. The company says its technology produces what it calls tumor treating fields, or TTFields, which exert physical forces that disrupt cancer cells and trigger their death. According to Novocure, these fields don’t significantly affect healthy cells because those cells have different properties than cancer cells.
The Novocure device is a portable, battery-operated system that administers the TTFs to the region where tumors are found. The electrical signals are delivered by electrodes placed directly on the skin. Novocure tested its device in patients whose stage 4 non-small cell lung cancer (NSCLC) had progressed on or after treatment with chemotherapy. The open-label study, which had a targeted enrollment of 276 patients, tested TTFields in combination with either a checkpoint inhibitor or docetaxel, a chemotherapy widely used to treat NSCLC.
Novocure said enrollment was balanced between the checkpoint inhibitor and docetaxel groups in both the experimental and control arms of the study. In addition to achieving the main goal of showing a benefit in overall survival, the company said the TTFields were well tolerated by patients.
Novocure’s TTFields are already treating cancer patients. In 2011, the FDA approved the company’s device, Optune, as a treatment for glioblastoma, a type of brain cancer. Another version of the technology called Optune Lua has a humanitarian device exemption to treat malignant pleural mesothelioma, a cancer affecting the lining of the lungs. For these indications, the technology is approved for use in combination with chemotherapy. But both glioblastoma and mesothelioma are rare. Regulatory approval in lung cancer, the most common cause of cancer deaths, would bring the Novocure technology to a much larger market.
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In addition to its current U.S. approvals, Novocure’s technology also has marketing authorizations in Europe and Japan. The company has also licensed its technology to Zai Labs, which sells the product in China. In 2022, Novocure reported $409.4 million in revenue through the third quarter, a 1.8% increase compared to the same period in the prior year. The vast majority of sales are from the U.S.
Despite the lack of detail in the preliminary data from the NSCLC study, investors welcomed the early results. Novocure’s stock price soared more than 68% on Thursday, closing at $118.81. The company said it plans to present full results from the study at a future medical conference. That conference was not specified, but more details could come as early as next week. A Novocure presentation is scheduled for Jan. 10 during the annual J.P. Morgan Healthcare Conference in San Francisco.
Photo by Flickr user Ignacio Zaera via a Creative Commons license
