Novocure has announced that the first patient has been enrolled in the METIS trial, a phase 3 pivotal trial studying radiosurgery plus Tumor Treating Fields (TTFields) compared to radiosurgery alone for the treatment of brain metastases from non-small cell lung cancer (NSCLC).
METIS is Novocure’s first phase 3 pivotal trial outside of glioblastoma.
“We have a clear, unmet need for an effective treatment for brain metastasis, a devastating, prevalent condition,” said Dr. Minesh P. Mehta, Deputy Director and Chief of Radiation Oncology at Miami Cancer Institute at Baptist Health South Florida.
“Existing treatments often cause significant neurological deterioration or do not prevent brain metastases from recurring. Based on the company’s pre-clinical research showing TTFields can prevent metastatic seeding in vivo and the established safety and efficacy of TTFields in glioblastoma, there is a strong scientific rationale for studying TTFields as a potential brain metastases treatment.”
The multicenter, open-label study will include 270 patients with 1 to 10 brain metastases who will be randomized 1:1 to receive, following radiosurgery, either TTFields at a frequency of 150kHz plus supportive care or supportive care alone.
The primary endpoint is time to first cerebral progression. Secondary endpoints include time to neurocognitive failure, overall survival and radiological response rate.
“We are happy to enroll the first patient in the METIS trial,” said Dr. Nicholas A. Blondin, Neuro-Oncology Program Director at Associated Neurologists of Southern Connecticut, in Fairfield, Connecticut. “Brain metastases patients deserve more treatment options, and this trial will assess the efficacy and safety of TTFields in the treatment of brain metastases.”
TTFields is a low-toxicity anti-mitotic treatment that uses low-intensity, intermediate frequency, alternating electric fields to exert physical forces on key molecules inside cancer cells, disrupting the basic machinery necessary for normal cell division, leading to cancer cell death.
“We are excited to start the METIS trial and are working to diligently enroll patients,” said Dr. Eilon Kirson, Chief Science Officer and Head of Research and Development at Novocure.
“NSCLC patients with brain metastases suffer not only from their primary disease in the lungs, but also from the risk of neurocognitive deterioration due to the recurrence of brain metastases or neurotoxic treatments. We believe TTFields has the potential be an effective treatment option to prevent the appearance of new brain metastases without causing additional neurotoxicity.”