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

Rhea-AI Summary

Optune is now a reimbursed treatment for newly diagnosed glioblastoma patients in France.

Novocure (NASDAQ: NVCR) announced that Optune is available alongside temozolomide (TMZ) for adult patients with glioblastoma (GBM). This follows its registration as a reimbursable product published in the Official Journal on February 28, 2023, effective March 15, 2023. Optune utilizes Tumor Treating Fields (TTFields) to disrupt cancer cell division and has treated over 27,000 patients worldwide. Clinical data from a phase 3 study showed median overall survival improved to 20.9 months with TTFields-TMZ versus 16.0 months with TMZ alone.

Positive

• Optune is now available and reimbursed for newly diagnosed glioblastoma patients in France.
• Clinical study shows significant improvement in median overall survival (20.9 months with TTFields-TMZ vs. 16.0 months with TMZ).
• Optune has treated over 27,000 patients globally, demonstrating its established use.

Negative

• None.

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

ROOT, Switzerland--(BUSINESS WIRE)-- 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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Investors:

Ingrid Goldberg

investorinfo@novocure.com

610-723-7427



Media:

Leigh Labrie

media@novocure.com

610-723-7428

Source: Novocure

FAQ

What is the significance of Optune being available in France for NVCR?

Optune's availability in France represents a key market expansion for Novocure, potentially increasing revenue and patient access.

What are the clinical results of Optune in glioblastoma treatment?

In clinical trials, Optune in combination with temozolomide showed a median overall survival of 20.9 months compared to 16.0 months for temozolomide alone.

When did Optune receive reimbursement approval in France?

Optune was registered for reimbursement on February 28, 2023, and the approval becomes effective on March 15, 2023.

How does Optune work as a treatment for glioblastoma?

Optune delivers Tumor Treating Fields (TTFields) that disrupt cancer cell division, targeting dividing cancer cells while minimizing damage to healthy cells.

What was the outcome of the phase 3 study for Optune?

The phase 3 EF-14 study found that patients using Optune plus temozolomide had a median progression-free survival of 6.7 months, significantly better than the 4.0 months for those using TMZ alone.