Novocure Announces Last Patient Enrolled in Pivotal METIS Study of Tumor Treating Fields in Brain Metastases from Non-Small Cell Lung Cancer

Rhea-AI Summary

Novocure (NASDAQ: NVCR) has completed enrollment in the pivotal METIS study, which evaluates Tumor Treating Fields (TTFields) therapy post-stereotactic radiosurgery (SRS) for patients with brain metastases from non-small cell lung cancer (NSCLC). The study enrolled 270 adult patients and focuses on various endpoints, including time to first intracranial progression. Novocure anticipates final data in 2024, marking a significant period for the company and treatment of solid tumor cancers. This study is the fourth pivotal trial completed by Novocure in 17 months, with a steady flow of new data expected through 2024.

Positive

• Completion of enrollment in the METIS study, enabling data collection and analysis.
• Study focuses on unmet medical needs in treating brain metastases from NSCLC.
• Expected to provide pivotal datasets enhancing the company's research pipeline.
• TTFields therapy may improve outcomes for solid tumor cancers.

Negative

• Completion of enrollment does not guarantee positive results from the METIS study.
• Dependence on upcoming pivotal datasets may introduce uncertainty.

Final data from the METIS study anticipated in 2024

ROOT, Switzerland--(BUSINESS WIRE)-- Novocure (NASDAQ: NVCR) today announced that the final patient has enrolled in the pivotal METIS study evaluating the efficacy of Tumor Treating Fields (TTFields) therapy following stereotactic radiosurgery (SRS) for treatment of patients with brain metastases resulting from non-small cell lung cancer (NSCLC).

“We are pleased to announce the completion of enrollment in the METIS study, our fourth pivotal study to complete enrollment in the last 17 months and our second study addressing non-small cell lung cancer,” said William Doyle, Novocure’s Executive Chairman. “Beginning with the top-line readout from the LUNAR study earlier this year, we expect a steady cadence of meaningful pivotal datasets through 2024. This is a transformational period for Novocure and, potentially, for the treatment of solid tumor cancers.”

Following the completion of enrollment, patients will be followed for a minimum of 12 months.

METIS is a randomized, open-label pivotal study which was designed to enroll 270 adult patients with between 1 and 10 brain metastases resulting from NSCLC. Following SRS, patients were randomized to receive either TTFields therapy and supportive treatment or supportive treatment alone. The primary endpoint is time to first intracranial progression. Secondary endpoints include, but are not limited to, time to neurocognitive failure, overall survival, radiological response rate, time to second intracranial progression, quality of life and adverse events.

About Brain Metastases

Metastatic cancer is cancer that has spread from the place where it first started to another place in the body. In metastasis, cancer cells break away from where they first formed (the primary cancer), travel through the blood or lymph system, and form new tumors (the metastatic tumors) in other parts of the body. The exact incidence of brain metastases is unknown because no national cancer registry documents brain metastases, and estimates from scientific literature vary greatly based on the study methodology applied. It is estimated that between 100,000 and 240,000 new cases are diagnosed in the U.S. each year with brain metastases estimated to occur in between 10% to 40% of all cancer patients.

Brain metastases are commonly treated with a combination of surgery and radiation. Chemotherapy is often given for the primary tumor, but many chemotherapy agents do not cross the blood brain barrier and are thus ineffective in the treatment of brain metastases. When brain metastases appear, they are either surgically removed or treated with radiation using SRS when possible. Whole brain radiation therapy, although effective in delaying progression or recurrence of brain metastases when given either before or after SRS, is associated with neurotoxicity and a significant decline in cognitive functioning. Thus, whole brain radiation therapy is often delayed until later in the disease course and is often used as a last resort. This practice results in a window of unmet need after localized surgery and SRS are used and before whole brain radiation therapy is administered to delay or prevent the additional spread of brain metastases.

About Tumor Treating Fields Therapy

Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. The multiple, distinct mechanisms of TTFields therapy work together to selectively target and kill cancer cells. Due to its multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or PARP inhibition in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors. To learn more about Tumor Treating Fields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230301005321/en/

Investors:

Ingrid Goldberg

investorinfo@novocure.com

610-723-7427

Media:

Leigh Labrie

media@novocure.com

610-723-7428

Source: Novocure

FAQ

What is the METIS study involving NVCR?

The METIS study evaluates the efficacy of Tumor Treating Fields therapy following stereotactic radiosurgery for brain metastases from non-small cell lung cancer.

When will the final data from the METIS study be available?

The final data from the METIS study is anticipated in 2024.

How many patients were enrolled in the METIS study?

The METIS study has enrolled 270 adult patients.

What are the primary endpoints of the METIS study?

The primary endpoint of the METIS study is time to first intracranial progression.

What is Tumor Treating Fields therapy?

Tumor Treating Fields therapy uses electric fields to target and kill cancer cells, sparing healthy cells.