NovoCure’s Tumor Treating Fields (TTFields) therapy met its primary endpoint in the Phase III METIS trial by slowing the progression of brain metastasis in patients with non-small cell lung cancer (NSCLC).
TTFields therapy is administered using the NovoTTF-200T device that generates mild electrical fields that pulse through the skin of the scalp and interrupt cancer cells’ ability to divide. This “field of interruption” can slow down a tumour’s growth and its ability to spread. The device has been approved by the US Food and Drug Administration (FDA) for the treatment of unresectable, locally advanced, or metastatic, malignant pleural mesothelioma.
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The open-label Phase III METIS trial (NCT02831959) enrolled 298 patients with NSCLC along with brain metastasis. The patients received either TTFields therapy along with supportive care or supportive care alone. Patients in the TTFields cohort had a median time to intracranial progression for brain metastasis of 21.9 months, compared to 11.3 months in patients in the supportive care-only cohort.
Median TTFields therapy treatment duration was 16 weeks and median usage was 67%. The company added that the preliminary analyses of key secondary endpoints, namely time to neurocognitive failure, overall survival, and radiological response rate, did not demonstrate statistical significance but were skewed in favour of TTFields therapy. Adding that a full analysis of secondary endpoints is ongoing.
Novocure plans to submit the trial data to regulatory bodies. Earlier this year, the company submitted a pre-market approval (PMA) application to the FDA seeking approval for TTFields therapy in conjunction with standard systemic therapies for the treatment of NSCLC. A decision on the PMA is expected in H2 2024.
The PMA application was based on data from the Phase III LUNAR trial (NCT02973789). Patients in the TTFields and standard therapy cohort demonstrated a median overall survival (OS) of 13.2 months, compared to 9.9 months in patients treated with standard therapies alone. When TTFields therapy was administered in combination with an immune checkpoint inhibitor, median OS survival improved to 18.5 months compared to a median OS of 10.8 months in patients receiving only an immune checkpoint inhibitor.
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By GlobalDataNovocure also tested the TTField therapy in other cancers, such as ovarian cancer. However, the therapy failed to meet the primary endpoint in the open-label Phase III trial (NCT03940196).
