Core Insights - Novocure announced the final results of the Phase 3 METIS trial for Tumor Treating Fields (TTFields) therapy, which demonstrated a significant delay in intracranial progression for patients with brain metastases from non-small cell lung cancer (NSCLC) [1][2][4] Group 1: Trial Overview - The METIS trial enrolled 298 adult patients with 1-10 brain metastases from NSCLC, randomized to receive either TTFields therapy with best supportive care (BSC) or BSC alone after stereotactic radiosurgery (SRS) [4] - The primary endpoint was the time to intracranial progression, measured from the first SRS treatment to either intracranial progression or neurological death [5] Group 2: Key Findings - Patients receiving TTFields therapy and BSC experienced a 28% lower risk of intracranial progression compared to those receiving BSC alone (HR 0.72, p=0.044) [6] - The median time to intracranial progression was 15.0 months for the TTFields group versus 7.5 months for the BSC alone group [6] - Progression rates at various time points showed significant improvements for the TTFields group: 13.6% at 2 months vs. 22.1% (p=0.034), 33.7% at 6 months vs. 46.4% (p=0.018), 46.9% at 12 months vs. 59.4% (p=0.023), and 53.6% at 24 months vs. 65.2% (p=0.031) [7] Group 3: Secondary Outcomes - No significant differences were observed in neurocognitive failure, overall survival, or radiological response of brain lesions [8] - Time to distant intracranial progression trended in favor of TTFields therapy, with a median of 18.6 months compared to 11.3 months for BSC alone (HR 0.76, p=0.165) [8] Group 4: Quality of Life and Safety - TTFields therapy did not lead to deterioration in quality of life, with improvements noted in deterioration-free survival and time to deterioration in health status and physical functioning [10] - The safety profile was consistent with previous trials, with grade 1/2 skin issues being the most common device-related adverse events [11] Group 5: Future Plans - Novocure plans to submit a premarket approval application to the FDA for TTFields therapy for adult patients with brain metastases from NSCLC in the coming weeks [3]