On May 31, 2016 Novocure (NASDAQ:NVCR) reported 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) (Press release, NovoCure, MAY 31, 2016, View Source [SID:1234512907]). 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.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
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."
About Brain Metastases
Metastatic cancer is cancer that has spread from the place where it first started to another place in the body. The exact incidence of brain metastases is unknown because no national cancer registry documents brain metastases, but it has been estimated that 98,000 to 170,000 new cases are diagnosed in the United States each year. Brain metastases cause an estimated 20% of all cancer deaths in the United States annually.
Tumor Treating Fields (TTFields) are not approved for the treatment of brain metastases by the U.S. Food and Drug Administration. The safety and effectiveness of TTFields therapy for brain metastases has not been established.