Novocure announced that the United States Food and Drug Administration (FDA) has approved its investigational device exemption (IDE) application to initiate the METIS trial.
METIS is a multi-center, phase 3, pivotal, open-label study of radiosurgery with or without Tumor Treating Fields (TTFields) for 1-10 brain metastases from non-small cell lung cancer (NSCLC).
270 patients will be randomized 1:1 to receive either TTFields delivered at an output frequency of 150kHz with supportive care or supportive care alone after radiosurgery. The primary endpoint of the METIS trial is time to first cerebral progression.
Secondary endpoints include, among others, time to neurocognitive failure, overall survival and radiological response rate following study treatments.
TTFields are low-intensity, alternating electric fields delivered to the region of a tumor. TTFields exert forces on key electrically charged molecules essential to the mitotic process by which all cells divide. Interference with the normal functioning of these key molecules leads to cell death through multiple pathways.
Treatment with TTFields, delivered via Optune, is currently approved in the United States and European Union for newly diagnosed and recurrent glioblastoma and in Japan for recurrent glioblastoma.
METIS will be Novocure’s first phase 3 pivotal trial outside of glioblastoma. Novocure has ongoing or completed phase 2 pilot trials in brain metastases, non-small cell lung cancer, pancreatic cancer, ovarian cancer and mesothelioma.
"Novocure remains focused on increasing Optune adoption for glioblastoma and on developing TTFields for a variety of additional solid tumors," said Asaf Danziger, Chief Executive Officer.
"We look forward to initiating a phase 3 pivotal trial in brain metastases given the unmet medical need. With the FDA IDE approval in hand, we are now working closely with trial sites and institutional review boards to open sites and enroll patients as quickly as possible."