Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), a biopharmaceutical company based in China, and Novocure (Nasdaq: NVCR), a UK-based oncology innovator, have announced positive results from the Phase III METIS trial. The trial evaluated the efficacy of the Tumor Treating Fields (TTFields) therapeutic device in combination with supportive care for patients with non-small cell lung cancer (NSCLC) and brain metastases. The study successfully met its primary endpoint, demonstrating a statistical improvement in time to intracranial progression.
The METIS trial included 298 adults with 1-10 brain metastases associated with NSCLC, who were randomized to receive either TTFields plus supportive care or supportive care alone. The median time to intracranial progression for the TTFields treatment group was 21.9 months, compared to 11.3 months in the control group (hazard ratio=0.67; P=0.016). The median duration of TTFields therapy was 16 weeks, with a median usage of 67%, and the safety and tolerability profiles were consistent with previous studies. The positive data will be utilized to support regulatory submissions in the near future, including in China, where Zai Lab supported the study and contributed Chinese patients since 2021.
Preliminary analyses indicated that key secondary endpoints, including time to neurocognitive failure, overall survival, and radiological response rate, did not achieve statistical significance, though a comprehensive analysis is still in progress. Brain metastases can develop in approximately 20%–65% of all lung cancer patients at some point during their illness and are present at diagnosis in about 10% of patients.- Flcube.com
