Novocure Enrolls First Patient in Phase 3 Pivotal Brain Metastases Trial
ST. HELIER, N.J., Oct. 12, 2016 (GLOBE NEWSWIRE) -- Novocure (NASDAQ: NVCR) announced today 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."
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 originating from non-small cell lung cancer is unknown because no national cancer registry documents brain metastases. It has been estimated that 98,000 to 170,000 new cases of brain metastases are diagnosed in the United States each year and, of those, the Company estimates that 40 percent originate from non-small cell lung cancer.
Tumor Treating Fields (TTFields) is not indicated for the treatment of brain metastases and is currently available for investigational use only in the United States.
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. Novocure's commercialized product, Optune, is approved for the treatment of adult patients with glioblastoma. Novocure has ongoing or completed phase 2 pilot trials investigating TTFields in NSCLC, pancreatic cancer, ovarian cancer and mesothelioma.
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.