Novocure Announces Reimbursement of Optune® for the Treatment of Newly Diagnosed Glioblastoma in France

Optune is now available as a treatment for newly diagnosed glioblastoma patients in France

Novocure (NASDAQ:NVCR) today announced the reimbursement and availability of Optune together with temozolomide (TMZ) for the treatment of adult patients with newly diagnosed glioblastoma (GBM) in France. The order registering Optune on the List of Reimbursable Products and Services (LPPR) provided for in Article L165-1 of the Social Security Code was published in the Official Journal on February 28, 2023 and will become effective March 15, 2023.

"We are pleased to make Optune available to French patients and healthcare professionals for the treatment of glioblastoma,” said Anne Calixte de Lembeye, General Manager of Novocure France. “GBM is one of the most common and most aggressive forms of primary brain cancer with a poor prognosis. We are energized and prepared to support patients in France as they begin to use our therapy as an additional treatment choice for newly diagnosed GBM."

Optune is a medical device that works by creating Tumor Treating Fields (TTFields), which are electric fields that disrupt cancer cell division. Optune delivers TTFields therapy to the region of the tumor. Optune is small and light, weighing 2.7 pounds. This makes Optune wearable and portable, so continuous treatment can be received almost anywhere. Globally, more than 27,000 patients have been treated with Optune, to date.

The favorable opinion of the CNEDIMTS (Commission Nationale d'Evaluation des Dispositifs Médicaux et des Technologies de Santé) was obtained on July 20, 2021. It highlights a sufficient expected service and a level III expected service improvement (ASA) for the use of Optune in combination with TMZ after surgery and radio-chemotherapy in adult patients with newly diagnosed GBM.

Novocure’s phase 3 pivotal EF-14 study compared Optune plus TMZ to TMZ alone in 695 patients with newly diagnosed GBM¹. Median progression-free survival from randomization was 6.7 months in the TTFields-TMZ group and 4.0 months in the TMZ-alone group (HR, 0.63; 95% CI, 0.52-0.76; P < .001). Median overall survival was 20.9 months in the TTFields-TMZ group versus 16.0 months in the TMZ-alone group (HR, 0.63; 95% CI, 0.53-0.76; P < .001). Optune was used together with TMZ with no significant increase in serious adverse events compared with TMZ alone. The most common side effect related to Optune alone was mild to moderate skin irritation.

Optune has the CE mark and is commercially available as a treatment for GBM in multiple countries in North America, Europe and Asia. In addition to France, Optune is reimbursed in Austria, Germany, Israel, Japan, Sweden, Switzerland and the United States.

“At Novocure, we feel a daily responsibility to bring our therapy to as many patients who can benefit throughout the world,” said Novocure CEO Asaf Danziger. “We are proud that Optune is now a treatment choice for newly diagnosed GBM patients in France. We look forward to supporting patients and physicians in France as they begin to use our therapy, and continue to work diligently to bring our therapy to patients in additional markets.”

About Optune

Optune is a noninvasive, antimitotic cancer treatment for glioblastoma (GBM). Optune delivers Tumor Treating Fields (TTFields) therapy to the region of the tumor.

Tumor Treating Fields therapy uses electric fields to disrupt cell division. Tumor Treating Fields does not stimulate or heat tissue and targets dividing cancer cells of a specific size. Tumor Treating Fields causes minimal damage to healthy cells. Mild to moderate skin irritation is the most common side effect reported. Tumor Treating Fields therapy is approved in certain countries for the treatment of adult patients with glioblastoma, malignant pleural mesothelioma and pleural mesothelioma, some of the most difficult cancer types to treat. The therapy shows promise in multiple solid tumor types – including some of the most aggressive forms of cancer.

About Novocure

Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields. Novocure’s commercialized products are approved in certain countries for the treatment of adult patients with glioblastoma, malignant pleural mesothelioma and pleural mesothelioma. Novocure has ongoing or completed clinical studies investigating Tumor Treating Fields in brain metastases, gastric cancer, glioblastoma, liver cancer, non-small cell lung cancer, pancreatic cancer and ovarian cancer.

Headquartered in Root, Switzerland and with a growing global footprint, Novocure has regional operating centers in Portsmouth, New Hampshire and Tokyo, as well as a research center in Haifa, Israel. For additional information about the company, please visit Novocure.com and follow @Novocure on LinkedIn and Twitter.

Forward-looking statements

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, clinical study progress, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, coverage, collections from third-party payers 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, environmental, regulatory and political conditions as well as issues arising from the COVID-19 pandemic and other more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on February 23, 2023, and subsequent filings 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.

1. Stupp, R., Taillibert, S., Kanner, A., Read, W., Steinberg, D., Lhermitte, B., Toms, S., Idbaih, A., Ahluwalia, M. S., Fink, K., Di Meco, F., Lieberman, F., Zhu, J. J., Stragliotto, G., Tran, D., Brem, S., Hottinger, A., Kirson, E. D., Lavy-Shahaf, G., Weinberg, U., … Ram, Z. (2017). Effect of Tumor-Treating Fields Plus Maintenance Temozolomide vs Maintenance Temozolomide Alone on Survival in Patients With Glioblastoma: A Randomized Clinical Trial. JAMA, 318(23), 2306–2316.

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