Novocure announced the presentation of clinical data from the phase 3 METIS trial, which investigated the use of Tumor Treating Fields (TTFields) therapy in the treatment of brain metastases from non-small cell lung cancer (NSCLC). These data will be presented at the ongoing 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, who were randomized following stereotactic radiosurgery (SRS) to receive either TTFields therapy and best supportive care (BSC) (n=149) or BSC alone (n=149).

METIS met its primary endpoint, demonstrating a statistically significant improvement in time to intracranial progression. Patients treated with TTFields therapy and BSC exhibited a median time to intracranial progression of 21.9 months compared to 11.3 months in patients treated with BSC alone (hazard ratio=0.67; P=0.016). Median TTFields therapy duration was 16 weeks and median usage was 67%.

Baseline patient demographics and characteristics were well balanced between arms. Patients treated with TTFields therapy demonstrated improved quality of life deterioration-free survival, with median time to quality of life deterioration-free survival not reached in the TTFields therapy cohort compared to 7.7 months in control arm (P=0.038). A positive trend was observed in patients treated with TTFields therapy in the majority of scales and items assessed by the EORTC QLQ C30 and BN20 patient questionnaire. There was no evidence of worsening cognitive functioning in the TTFields therapy arm compared to the control arm.

Consistent with prior clinical trials, TTFields therapy was well-tolerated with no additive systemic toxicity. Preliminary analyses of key secondary endpoints did not demonstrate statistical significance. Median overall survival for patients randomized to receive TTFields therapy and BSC was 11.3 months compared to 10.6 months in patients treated with BSC alone.

Full analysis of secondary endpoints is ongoing.