Den kliniska fas III-studien METIS utvärderar TTFields vid behandling av hjärnmetastaser till följd av icke-småcellig lungcancer.
Nu meddelas att studien uppnådde sitt primära effektmått, en signifikant förbättring av tiden till intrakraniell progression för patienter som behandlats med Tumor Treating Fields och supportive care jämfört med enbart supportive care efter stereotaktisk strålbehandling.
I TTFields-gruppen var mediantiden till första intrakraniella progression 21,9 månader vilket ska jämföras med 11,3 månader för patienter som enbart fick supportive care.
Som i tidigare studier visade sig TTFields vara väl tolererat med bibehållen livskvalitet och neurokognitiv funktion.
De fullständiga resultaten kommer att presenteras vid en kommande vetenskaplig kongress.
Novocure (NASDAQ: NVCR) announced the phase 3 METIS clinical trial met its primary endpoint, demonstrating a statistically significant improvement in time to intracranial progression for adult patients treated with Tumor Treating Fields (TTFields) therapy and supportive care compared to supportive care alone in the treatment of patients with 1–10 brain metastases from non-small cell lung cancer (NSCLC) following stereotactic radiosurgery (SRS). Patients treated with TTFields therapy and supportive care exhibited a median time to intracranial progression of 21.9 months compared to 11.3 months in patients treated with supportive care alone for brain metastasis (n=298; hazard ratio=0.67; P=0.016). Median TTFields therapy treatment duration was 16 weeks and median usage was 67%. Consistent with previous studies, TTFields therapy was well-tolerated with sustained quality of life and neurocognitive function. Baseline characteristics were well balanced between arms.
“Patients with brain metastases from non-small cell lung cancer are frequently treated with radiosurgery but face a high likelihood of rapid brain relapse,” said Minesh Mehta, MD, Chief of Radiation Oncology and Deputy Director at Miami Cancer Institute, part of Baptist Health South Florida. “In this international, multicenter, phase 3 trial, the use of TTFields therapy significantly delayed time to brain relapse, with associated improvement in quality of life and stable cognition. This is a major benefit and is potentially practice changing.”
Preliminary analyses of key secondary endpoints (time to neurocognitive failure, overall survival, and radiological response rate) did not demonstrate statistical significance. 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’s willingness to pursue areas of considerable unmet need, like the patient population studied in METIS, is a point of pride for our company,” said Asaf Danziger, Novocure’s Chief Executive Officer. “We are so pleased with the positive outcome of this trial and encouraged by TTFields’ performance. I would like to thank everyone involved with METIS, especially our courageous patients and dedicated investigators, for their contributions to the trial and for meaningfully contributing to the evolution of treatment of brain metastases from NSCLC.”
Novocure intends to submit these data to regulatory authorities. Novocure also intends to publish these findings in a peer-reviewed scientific journal and share them at an upcoming scientific congress.
