Novocure Receives IDE Approval to Initiate METIS Trial
This sounds like a great combination. Radiosurgery can usually control an individual brain met over 90% of the time, however the patient usually still develops new mets in the brain - because the radiosurgery doesn't do anything for the little islands of tumor cells that you can't yet see on the scans. The TTFields might be able to stop those islands from developing into new tumors.
Posted on: 05/31/2016
31 May 2016
Novocure Receives IDE Approval to Initiate METIS Trial
Phase 3 pivotal trial will study radiosurgery plus Tumor Treating Fields compared to radiosurgery alone for brain metastases from non-small cell lung cancer
St. Helier, Jersey – Novocure (NASDAQ: NVCR) announced today 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.”
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.
Novocure is a commercial-stage oncology company developing a novel, proprietary therapy called Tumor Treating Fields, or TTFields, for the treatment of solid tumor cancers. Headquartered in Jersey, Novocure has U.S. operations in Portsmouth, New Hampshire, Malvern, Pennsylvania, and New York City. Additionally, the company has offices in Germany, Switzerland and Japan, and a research center in Haifa, Israel. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure.
In the United States, Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).
In the United States, Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy.
In the United States, for the treatment of recurrent GBM, Optune is indicated following histologically-or radiologically-confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.
In the European Union, Optune is intended for the treatment of patients with newly diagnosed GBM, after surgery and radiotherapy with adjuvant temozolomide, concomitant to maintenance temozolomide. The treatment is intended for adult patients, 18 years of age or older, and should be started more than four weeks after surgery and radiation therapy with adjuvant temozolomide. Treatment may be given together with maintenance temozolomide and after maintenance temozolomide is stopped.
In the European Union, Optune is also intended for the treatment of patients with recurrent GBM who have progressed after surgery, radiotherapy and temozolomide treatment for their primary disease. The treatment is intended for adult patients, 18 years of age or older, and should be started more than 4 weeks after the latest surgery, radiation therapy or chemotherapy.
Patients should only use Optune under the supervision of a physician properly trained in use of the device. Full prescribing information is available at www.optune.com/safety or by calling toll free 1-855-281-9301 in the US or by email at supportEMEA@novocure.com in the European Union.
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. Novocure's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions as well as more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on March 1, 2016, with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.
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