TTFields Improves Time to Progression in Brain Metastases From NSCLC

TTFields Improves Time to Progression in Brain Metastases From NSCLC

Tumor-treating fields (TTFields) plus supportive care significantly improved time to intracranial progression in adult patients with brain metastases from non-small cell lung cancer (NSCLC), which met the primary end point of the phase 3 METIS trial (NCT02831959).¹

With a median treatment duration of 16 weeks, patients who were treated with TTFields and supportive care had a median time to intracranial progression of 21.9 months vs 11.3 months for patients treated with supportive care alone (n = 298; HR, 0.67; P =.016).

“Patients with brain metastases from non-small cell lung cancer are frequently treated with radiosurgery but face a high likelihood of rapid brain relapse,” said Minesh Mehta, MD, chief of radiation oncology and deputy director at Miami Cancer Institute, part of Baptist Health South Florida, in a press release. “In this international, multicenter, phase 3 trial, the use of TTFields therapy significantly delayed time to brain relapse, with associated improvement in quality of life and stable cognition. This is a major benefit and is potentially practice changing.”

A full analysis of the key secondary end points, including time to neurocognitive failure, overall survival, and radiological response rate, is ongoing and will be reported at a later date. Further, these data will be presented to regulatory authorities, published in a scientific journal, and shared at an upcoming medical meeting.

About the Phase 3 METIS Study

The phase 3, pivotal, open-label, randomized METIS study enrolled an estimated 270 patients across 28 states in the US, as well as in Austria, Bulgaria, Canada, China, Croatia, France, Germany, Hong Kong, Hungary, Israel, Italy, Poland, Serbia, and Spain.² Patients were randomized to receive treatment with the NovoTTF-200M device or best standard of care.

To be eligible for participation, patients had to be 18 years or older, have a life expectancy of at least 3 months, have a new diagnosis of brain metastases stemming from NSCLC within 5 years of study enrollment, and 1 inoperable brain metastasis or 2 to 10 brain lesions per screening MRI. Patients were ineligible for study enrollment if they had a single operable brain lesion, significant edema, intractable seizures, leptomeningeal metastases, recurrent brain metastases, or severe comorbidities. Patients with ALK, EGFR, ROS1, proto-oncogene, and proto-oncogene BRAF mutations for whom targeted therapies were available were also not eligible for study enrollment.

The study has an estimated completion of December 2024.

References

1. METIS phase 3 clinical trial met primary end point, demonstrating a statistically significant extension in time to intracranial progression for patients with brain metastases from non-small cell lung cancer. News release. Novocure. March 27, 2024. Accessed March 27, 2024. https://tinyurl.com/42mwsx47
2. Pivotal, open-label, randomized study of radiosurgery with or without tumor treating fields (TTFields) for 1-10 brain metastases from non-small cell lung cancer (NSCLC). ClinicalTrials.gov. Updated March 10, 2023. Accessed March 27, 2024. https://clinicaltrials.gov/study/NCT02831959