German Federal Joint Committee Announces Decision to Support a Clinical Trial to Study Optune® for the Treatment of Newly Diagnosed Glioblastoma
Proposed trial design will examine the benefit of combining Optune with radiation therapy and temozolomide prior to the initiation of maintenance temozolomide
ST. HELIER, Jersey–(BUSINESS WIRE)– Novocure (NASDAQ: NVCR) today announced that the German Federal Joint Committee, (Gemeinsamer Bundesausschuss or G-BA), has published its decision to support a clinical trial studying Optune for the treatment of newly diagnosed glioblastoma (GBM).1 The proposed trial design will examine the benefit of combining Optune with radiation therapy and temozolomide prior to the initiation of maintenance temozolomide in accordance with Section 137e of the German Healthcare Provision Act. The G-BA decision is an important first step in Novocure’s process to secure national reimbursement for Optune in Germany.
The trial design as proposed would enroll 933 patients. Novocure and the G-BA will share the costs for the conduct of the clinical trial. The statutory health insurance funds will reimburse treatment costs, including the cost of Optune for trial patients.
“The decision by the G-BA to study Optune in combination with radiation therapy for the treatment of newly diagnosed GBM will provide valuable data on the benefits of initiating therapy earlier in the course of GBM treatment,” said Eilon Kirson, Novocure’s Chief Science Officer and Head of Research and Development. “We are excited to understand the possible impact of earlier initiation of Optune in newly diagnosed GBM and are pleased to partner with the G-BA for this pivotal trial.”
The positive decision to initiate a clinical trial does not imply immediate funding. Before the trial can begin, the G-BA subcommittee for assessment of new methods must issue a final directive for approval by the German Ministry of Health. The German Ministry of Health approval process and subsequent initiation of the clinical trial is anticipated to take up to an additional 18 months, and could take longer. In the interim, Novocure will continue to bill German healthcare payers for individual cases. Each case is evaluated individually on its merits and under the payer’s specific rules for such cases.
1 G-BA decision available at: https://www.g-ba.de/informationen/beschluesse/3038/.
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 GBM 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 Europe, 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 4 weeks after surgery and radiation therapy with adjuvant temozolomide. Treatment may be given together with maintenance temozolomide and after maintenance temozolomide is stopped.
In Europe, 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 Europe.
Novocure is an oncology company developing a profoundly different cancer treatment utilizing a proprietary therapy called TTFields, the use of electric fields tuned to specific frequencies to disrupt solid tumor cancer cell division. Novocure’s commercialized product, Optune, is approved for the treatment of adult patients with glioblastoma. Novocure has ongoing or completed clinical trials investigating TTFields in brain metastases, non-small cell lung cancer, 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, Japan and Israel. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure.
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 February 23, 2017, 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.
Media and Investor Contact:
Ashley Cordova, 212-767-7558