METIS Phase 3 Trial Met Primary Endpoint, Delaying Intracranial Progression and Improving Quality of Life

NovoCure Ltd. (NASDAQ: NVCR) has recently unveiled promising clinical data from the phase 3 METIS trial, which assessed the effectiveness of Tumor Treating Fields (TTFields) therapy in managing brain metastases in patients with non-small cell lung cancer (NSCLC). The findings were shared at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

The METIS trial enrolled 298 adult patients with 1-10 brain metastases from NSCLC. After undergoing stereotactic radiosurgery (SRS), participants were randomly assigned to receive either TTFields therapy combined with best supportive care (BSC) (n=149) or BSC alone (n=149). The primary objective of the trial was to evaluate the time to intracranial progression. Results indicated a statistically significant improvement for patients receiving TTFields therapy and BSC, with a median time to intracranial progression of 21.9 months, compared to 11.3 months for patients receiving only BSC (hazard ratio=0.67; P=0.016). Median duration of TTFields therapy was 16 weeks with a 67% median usage rate. Baseline characteristics and patient demographics were balanced across both study groups.

Beyond extending the time to intracranial progression, TTFields therapy was also associated with prolonged quality of life deterioration-free survival. The median time to quality of life deterioration-free survival had not been reached in the TTFields cohort, while it stood at 7.7 months for the control group (P=0.038). Notably, there was no observed decline in cognitive functioning among patients treated with TTFields therapy when compared to the control group, and the therapy was well-tolerated with no additional systemic toxicity observed.

However, preliminary analyses of secondary endpoints did not yield statistically significant results. For instance, the median overall survival was 11.3 months for patients receiving TTFields therapy and BSC, compared to 10.6 months in the BSC-only group. Further detailed analysis of secondary endpoints is ongoing.

Dr. Minesh Mehta, Chief of Radiation Oncology and Deputy Director at Miami Cancer Institute, emphasized the critical challenge of maintaining patients' quality of life and cognitive function while combating brain metastases. He highlighted TTFields therapy's potential to prolong the time to intracranial progression without adversely affecting quality of life or cognitive function, potentially shifting the treatment paradigm for brain metastases from NSCLC.

Dr. Nicolas Leupin, Novocure's Chief Medical Officer, remarked on the limited treatment options available for brain metastases from NSCLC and underscored the significance of the METIS trial findings as a potential new treatment avenue.

Dr. Mehta will present these findings in an oral presentation at the ASCO Central Nervous System Tumors session. Novocure aims to publish the results in a peer-reviewed journal and submit the data to regulatory authorities for further evaluation.

The METIS trial [NCT02831959] is a phase 3 study evaluating the combination of stereotactic radiosurgery with or without TTFields therapy for patients with 1-10 brain metastases from NSCLC. The study's primary endpoint is the time to first intracranial progression, with secondary endpoints including time to distant progression, time to neurocognitive failure, overall survival, and quality of life among others. Patients were stratified based on the number of metastases, prior systemic therapy, and tumor histology, and were allowed to switch to the TTFields therapy arm after confirmation of second intracranial progression.

TTFields therapy employs electric fields to selectively target and kill cancer cells without significantly affecting healthy cells. This multimechanistic action offers potential synergy with other cancer treatment modalities such as chemotherapy, radiotherapy, and immunotherapy.

Novocure is a global oncology company focused on extending survival in aggressive cancers through TTFields therapy. The company is headquartered in Root, Switzerland, and has operations in Portsmouth, New Hampshire, Tokyo, and a research center in Haifa, Israel. The company continues to explore the application of TTFields therapy across a variety of solid tumors.