Novocure (NASDAQ: NVCR) announced today that it has enrolled the final patient in the pivotal METIS study, which is evaluating the efficacy of Tumor Treating Fields (TTFields) therapy after stereotactic radiosurgery (SRS) for the treatment of patients with brain metastases who derived from non-small cell lung cancer (NSCLC).
“We are pleased to announce the completion of enrollment for the METIS study, our fourth pivotal study to complete enrollment in the past 17 months and our second study targeting non-small cell lung cancer,” said William Doyle, Executive Chairman of Novocure. “Starting with the top-line data from the LUNAR study earlier this year, we expect a steady cadence of meaningful pivotal datasets through 2024. This is a transformational phase for Novocure and potentially for the treatment of solid tumors.”
After registration is complete, patients will be followed up for at least 12 months.
METIS is a pivotal, randomized, open-label study that was planned to enroll 270 adult patients with between 1 and 10 brain metastases from NSCLC. After SRS, patients were randomized to receive either TTFields therapy and supportive care or supportive care only. The primary endpoint is time to first intracranial progression. Secondary endpoints include time to neurocognitive failure, overall survival, radiographic response rate, time to second intracranial progression, quality of life, and adverse events.
About brain metastases
Metastatic cancer is cancer that has spread from where it first originated to another part of the body. In metastasis, cancer cells break away from the site where they originally formed (the primary cancer), travel through the blood or lymphatic 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 the scientific literature vary widely depending on the study methodology used. It is estimated that between 100,000 and 240,000 new cases of brain metastases are diagnosed in the US each year, accounting for an estimated 10% to 40% of all cancer patients.
Brain metastases are usually treated with a combination of surgery and radiation. The primary tumor is often treated with chemotherapy, but many chemotherapy drugs do not cross the blood-brain barrier and are therefore ineffective in treating brain metastases. If brain metastases do occur, they are either surgically removed or, if possible, treated with SRS radiation. Whole-brain radiation therapy, while effective in delaying the progression or recurrence of brain metastases when administered either before or after SRS, is associated with neurotoxicity and significant deterioration in cognitive function. As a result, whole-brain radiation therapy is often postponed until later in the disease process and is often used as a last resort. This practice creates a window of unmet need after localized surgery and SRS are used and before whole-brain radiation therapy is administered to delay or prevent additional spread of brain metastases.
About tumor treatment field therapy
Tumor Treating Fields (TTFields) are electrical fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields have no significant impact on healthy cells as they have different properties (including division rate, morphology and electrical properties) than cancer cells. The multiple, different mechanisms of TTFields therapy work together to selectively target and kill cancer cells. Due to its multimechanistic effects, TTFields therapy can be added to cancer treatment modalities in approved indications and shows improved effects in solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or PARP inhibition in preclinical models. TTFields therapy offers clinical versatility that has the potential to help address treatment challenges in a range of solid tumors. To learn more about Tumor Treating Fields therapy and its multiple effects on cancer cells, visit tumortreatingfields.com.
About Novocure
Novocure is a global oncology company working to extend survival for some of the most aggressive types 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 treatment areas in brain metastasis, gastric cancer, glioblastoma, liver cancer, non-small cell lung cancer, pancreatic cancer and ovarian cancer.
Headquartered in Root, Switzerland, Novocure has a growing global footprint, with regional operations centers in Portsmouth, New Hampshire and Tokyo, and a research center in Haifa, Israel. For more information about the company, please visit Novocure.com and follow @Novocure on LinkedIn and Twitter.
Forward-Looking Statements
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