Cancer that starts in the lungs typically spreads. If it hasn’t reached the brain at the time of the initial diagnosis, brain metastasis still looms as a risk. A Novocure medical device that uses electricity to kill tumors now has data from a pivotal study showing it can slow the progression of cancer that has spread to the brain.
The results announced Wednesday are preliminary and Novocure said more details will be published in a peer-reviewed journal and presented at a future scientific meeting. But the Switzerland-based company says it has enough information to share with regulators as it looks ahead to the therapy’s next steps.
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Novocure’s portable, battery-powered device uses “Tumor Treating Fields,” or TTFields, that exert physical forces to kill cancer cells. The electricity is delivered by electrodes placed on the skin. Novocure says its TTFields do not affect healthy cells, which have different division rate, morphology, and electrical properties than cancer cells.
The open label Phase 3 test enrolled 298 adult non-small cell lung cancer (NSCLC) patients who had received radiation treatment for one to 10 brain metastases. Those study participants were randomly assigned to receive TTFields and supportive care or supportive care alone. Patients in both arms of the study could receive systemic therapy for their NSCLC at the discretion of the treating physician. Those with known tumor mutations that can be treated with available targeted therapies were excluded from the clinical trial.
The electrical treatment was administered via four electrodes worn continuously on the head. The main goal was to measure the time from the start of treatment until the start of cancer progression in the brain. Results showed the median time to progression in the TTFields arm was 21.9 months compared to a median time of 11.3 months in the supportive care alone arm. The median duration of treatment was 16 weeks. Novocure said the therapy was well tolerated and study participants were able to maintain quality of life and neurocognitive function.
The news was not all good. On secondary goals of measuring the time to neurocognitive failure, overall survival, and radiological response rate, Novocure said the electrical treatment did not demonstrate statistical significance. The company did not offer additional detail. However, it said that on certain secondary endpoints, results showed “positive trends in favor of treatment with TTFields therapy.” Full analysis of the results for the secondary goals is ongoing.
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In a note sent to investors Wednesday, Leerink Partners analyst Jonathan Chang wrote that the preliminary data, particularly the greater than 10 month improvement on the main clinical trial goal, are supportive of the Novocure device’s ability to provide real benefit in this patient population. Chang acknowledged the lack of statistical significance on the study’s secondary goals and said disclosure of the full clinical trial data are needed to understand those results.
Novocure’s medical device is already under FDA review for the treatment of non-small cell lung cancer that has progressed following platinum-based therapy. The device is being reviewed under the premarket approval pathway; a regulatory decision is expected in the second half of this year. That application is based on positive Phase 3 data that Novocure announced last year for its TTFields-generating device.
Image: mrspopman, Getty Images
