Swiss biotech Novocure announced Wednesday its Tumor Treating Fields therapy reached the primary endpoint in a Phase III trial in patients with brain metastases from non-small cell lung cancer after stereotactic radiosurgery.
Novocure’s Tumor Treating Fields (TTFields) is an investigational oncology therapy that uses electric fields that act via many different mechanisms to kill cancer cells. According to the company, the late-stage METIS trial met its primary endpoint, showing a statistically significant improvement in time to intracranial progression in adult patients with brain metastases treated with TTFields therapy and supportive care compared to supportive care alone.
The patients, who had one to 10 brain metastases from non-small cell lung cancer (NSCLC), were treated with the TTFields therapy and supportive care demonstrating a median time to intracranial progression of 21.9 months compared to 11.3 months in patients that had supportive care alone. The endpoint also earned a p-value of 0.016. The duration of the median therapy treatment with TTFields was 16 weeks, and median usage was recorded at 67%.
According to Novocure, its TTFields therapy was well tolerated in the trial with sustained quality of life and neurocognitive functions.
At the same time, the secondary endpoints of neurocognitive failure, overall survival and radiological response rate did not demonstrate statistical significance. Still, Novocure said that some of the secondary endpoints showed “positive trends” in favor of TTFields therapy, such as a time to distant progress and quality of life. The company added that the complete analysis of the secondary endpoints is ongoing.
Novocure’s stock jumped more than 15% in Wednesday morning trading.
The biotech plans to submit the data to regulatory authorities, publish these in a peer-reviewed scientific journal and present them at an unspecified scientific congress.
“Novocure’s willingness to pursue areas of considerable unmet need, like the patient population studied in METIS, is a point of pride for our company,” Novocure CEO Asaf Danziger said in a statement. “We are so pleased with the positive outcome of this trial and encouraged by TTFields’ performance. I would like to thank everyone involved with METIS, especially our courageous patients and dedicated investigators, for their contributions to the trial and for meaningfully contributing to the evolution of treatment of brain metastases from NSCLC.”
Novocure's TTFields therapy uses electric fields that can emit physical forces to kill cancer cells, while not affecting healthy cells significantly due to the fact that they have different properties—including division rate, morphology and electrical properties—than cancer cells, according to the company. Last year, a Phase III investigation of TTFields in NSCLC reached its primary endpoint, showing improvement in overall survival versus standard therapies.
“Patients with brain metastases from non-small cell lung cancer are frequently treated with radiosurgery but face a high likelihood of rapid brain relapse,” Minesh Mehta, chief of radiation oncology and deputy director at the Miami Cancer Institute, said in a Wednesday statement. “In this international, multicenter, Phase III trial, the use of TTFields therapy significantly delayed time to brain relapse, with associated improvement in quality of life and stable cognition.”
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