On April 24, 2024 Novocure (NASDAQ: NVCR) reported 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) (Free ASCO Whitepaper) Annual Meeting in Chicago, to be held from May 31 to June 4 (Press release, NovoCure, APR 24, 2024, View Source [SID1234642317]).
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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 (Free ASCO Whitepaper), 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 (Free ASCO Whitepaper) 2024."
The METIS data will be presented on June 3 as a late-breaking abstract during ASCO (Free ASCO Whitepaper)’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 (Free ASCO Whitepaper) 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.