The international multicenter phase III METIS (EF-25) trial has met its primary endpoint, significantly prolonging time to intracranial progression of brain metastases in mutation negative non-small cell lung cancer (NSCLC) patients who underwent stereotactic radiosurgery followed by Tumor Treating Fields (TTFields).

Data from the study will be presented at the annual meeting of the American Society of Clinical Oncology (ASCO) on June 3 in Chicago by co-principal investigator Minesh Mehta, M.D., deputy director of Miami Cancer Institute, chief of Radiation Oncology at Baptist Health, and professor and chair of Radiation Oncology at Florida International University. See the abstract here.

“While there is more data analysis to be done, the median time to intracranial progression with best supportive care was 11.3 months, while the median time to intracranial progression with best supportive care plus TTFields was 21.9 months,” Dr. Mehta said.

In addition, the trial showed that the likelihood of developing new metastases in the brain in NSCLC patients is decreased when using TTField therapy, he said. “The implication is that TTFields are effective for small, microscopic disease. We are optimistic that we are changing the outlook for patients with brain metastases.”

TTFields disrupt cancer cell division and were shown in preclinical NSCLC models to be efficacious. In earlier studies on patients with glioblastoma, as well as metastatic non-small cell lung cancer, the use of TTFields improved overall survival and the treatment was tolerated well by patients.

Brain metastases are among the most debilitating events for cancer patients and shorten life span significantly. With estimates of the numbers of cases each year ranging between 100,000 and 300,000 in the U.S., the need for additional treatments is considerable. Upwards of one-third of NSCLC patients present with brain metastases at the time of diagnosis.

The presentation, “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,” also revealed that TTFields therapy did not negatively impact cognition and improved quality of life measures such as deterioration-free survival of global health status, physical functioning and fatigue.

Dr. Mehta’s presentation is among several at ASCO featuring Miami Cancer Institute’s experts on glioblastoma and brain metastases, breast cancer and HPV-related cancers.