On March 1, 2023 Novocure (NASDAQ: NVCR) reported 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) (Press release, NovoCure, MAR 1, 2023, View Source [SID1234628020]).
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"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.