NovoCure Phase 3 Trial Shows 21.9-Month Progression Extension

Novocure (NASDAQ: NVCR) has just announced the results of its phase 3 METIS clinical trial, which demonstrated a significant extension in the time to intracranial progression for patients with brain metastases from non-small cell lung cancer (NSCLC). The trial showed a median time to intracranial progression of 21.9 months for patients treated with tumor treating fields (TTFields) therapy and supportive care, compared to 11.3 months for patients treated with supportive care alone. This marks a substantial improvement, with a hazard ratio of 0.67 and a p-value of 0.016.

The median TTFields therapy treatment duration was 16 weeks, with a median usage of 67%, and was well-tolerated by patients, maintaining quality of life and neurocognitive function. The METIS trial involved 298 adult patients with 1-10 brain metastases from NSCLC who had undergone stereotactic radiosurgery (SRS).

While the primary endpoint was met, preliminary analyses of key secondary endpoints such as time to neurocognitive failure, overall survival, and radiological response rate did not demonstrate statistical significance. However, certain secondary endpoints showed positive trends in favor of treatment with TTFields therapy, including time to distant progression and quality of life. Full analysis of secondary endpoints is ongoing.

Novocure plans to submit these data to regulatory authorities and publish the findings in a peer-reviewed scientific journal, as well as share them at an upcoming scientific congress.

The company's CEO, Asaf Danziger, expressed his satisfaction with the positive outcome of the trial and the performance of TTFields therapy, highlighting Novocure's commitment to addressing areas of considerable unmet need.

The METIS trial has the potential to be practice-changing, as it presents a major benefit for patients with brain metastases from NSCLC. Patients with this condition often face a high likelihood of rapid brain relapse, and the use of TTFields therapy significantly delayed the time to brain relapse and improved quality of life and stable cognition.

Brain metastases are a negative prognostic factor in NSCLC, affecting neurocognitive function and quality of life. Approximately 25% of NSCLC patients have brain metastases at diagnosis, and the lifetime risk among these patients is around 50%. Novocure's innovative therapy, TTFields, has the potential to address the unmet need for greater intracranial control while minimizing the risk of neurocognitive adverse events.

Novocure is a global oncology company that focuses on extending survival in aggressive forms of cancer through the development and commercialization of innovative therapies. The company's commercialized products are approved in certain countries for the treatment of adult patients with glioblastoma and malignant pleural mesothelioma. Novocure has ongoing or completed clinical studies investigating TTFields in various cancers, including brain metastases, gastric cancer, liver cancer, pancreatic cancer, and ovarian cancer. The market has reacted to these announcements by moving the company's shares 14.2% to a price of $14.93. For more information, read the company's full 8-K submission here.

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