Novocure (NASDAQ: NVCR) today announced the results of the METIS phase 3 clinical trial in brain metastases from non-small cell lung cancer (NSCLC) will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, to be held from May 31 to June 4.

METIS was a randomized phase 3 clinical trial of stereotactic radiosurgery with or without Tumor Treating Fields (TTFields) therapy for patients with 1-10 brain metastases from NSCLC. In March, Novocure announced METIS met its primary endpoint, demonstrating a statistically significant improvement in time to intracranial progression for adult patients with Tumor Treating Fields (TTFields) therapy and supportive care compared to supportive care alone.

“We are honored to present the results of the METIS clinical trial as a late-breaking abstract this year at ASCO, the largest global oncology conference,” said Asaf Danziger, Novocure’s Chief Executive Officer. “Patients with brain metastases from non-small cell lung cancer need more treatment options. The METIS trial demonstrated that TTFields Therapy delayed intracranial progression while preserving neurological function, which is critical for these underserved patients. We look forward to robust discussion around the positive results of the METIS clinical trial, as well as other TTFields therapy program updates at ASCO 2024.”

The METIS data will be presented on June 3 as a late-breaking abstract during ASCO’s Central Nervous System Tumors session from 8 a.m. to 10 a.m. CDT. Lead author Minesh Mehta, MD, Chief of Radiation Oncology and Deputy Director at Miami Cancer Institute, part of Baptist Health South Florida, will give the presentation.

The oral presentation of the METIS clinical trial data is one of four abstracts on TTFields therapy to be included at the 2024 ASCO Annual Meeting.

Abstract titles from Novocure-sponsored and partner programs include:

  • Results from METIS (EF-25), an International, Multicenter Phase III Randomized Study Evaluating the Efficacy and Safety of Tumor Treating Fields (TTFields) Therapy in NSCLC Patients with Brain Metastases. Abstract 2008. 10:24 a.m. CDT on June 3.

  • Tumor Treating Fields (TTFields) therapy in patients with glioblastoma: Long-term survival results from TTFields in Germany in routine clinical care (TIGER) study. Abstract 2036. 9 a.m. CDT on June 1.

  • LUNAR-2: Pivotal, Randomized, Open-Label Study of Tumor Treating Fields (TTFields, 150 kHz) Concomitant with Pembrolizumab and Platinum Based Chemotherapy for the Treatment of Metastatic Non-Small Cell Lung Cancer. Abstract TPS8665. 1:30 p.m. CDT on June 3.

  • Deep Learning Convolutional Neural Networks Reliably Monitor and Accurately Identifies Predictors of Response to Novo-TTFields. Publication Only.

ABOUT METIS

METIS [NCT02831959] was a phase 3 trial of stereotactic radiosurgery with or without TTFields therapy for patients with 1-10 brain metastases from NSCLC. 298 adult patients were enrolled in the trial and randomized to receive either TTFields therapy with supportive care or supportive care alone following SRS. Supportive care consisted of, but was not limited to, treatment with steroids, anti-epileptic drugs, anticoagulants, pain control or nausea control medications. Patients in both arms of the study were eligible to receive systemic therapy for their NSCLC at the discretion of their treating physician. Patients with known tumor mutations for which targeted agents are available were excluded from the trial.

The primary endpoint of the METIS trial is time to first intracranial progression, as measured from the date of first SRS treatment to intracranial progression or neurological death (per RANO-BM criteria), whichever occurs first. Time to intracranial progression was calculated according to the cumulative incident function. Patient scans were evaluated by a blinded, independent radiologic review committee. Secondary endpoints include, but are not limited to, time to distant progression, time to neurocognitive failure, overall survival, time to second intracranial progression, quality of life and adverse events. Key secondary endpoints (time to neurocognitive failure, overall survival, and radiological response rate) were planned to be used in labeling claims, if successful. Patients were stratified by the number of brain metastases (1-4 or 5-10 metastases), prior systemic therapy, and tumor histology. Patients were allowed to crossover to the experimental TTFields therapy arm following confirmation of second intracranial progression.

The METIS clinical trial data are expected to serve as the basis for future regulatory discussions.

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 targeted therapies 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 and malignant 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 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 22, 2024, 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.

INVESTORS AND MEDIA:
Ingrid Goldberg
investorinfo@novocure.com
media@novocure.com

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