NovoCure Limited announced that the final patient has been enrolled in the global phase 3 TRIDENT clinical trial evaluating the safety and efficacy of initiating Optune Gio® (formerly known as Optune®) concurrent with radiation therapy and temozolomide (TMZ) for the treatment of adult patients with newly diagnosed glioblastoma (GBM). Optune Gio® is currently approved for use together with maintenance TMZ for the treatment of newly diagnosed GBM following maximal debulking surgery and the completion of radiation therapy. The TRIDENT clinical trial is a randomized, open-label study designed to enroll 950 adult patients with newly diagnosed GBM.

Following maximal debulking surgery, patients enrolled in TRIDENT were randomized to receive either TTFields therapy, concomitant with TMZ and radiation therapy, or TMZ and radiation therapy for six weeks. Following the initial six-week period, all patients receive the current standard of care ? TTFields therapy together with maintenance TMZ for a period of 24 months or until a second disease progression is experienced.

TRIDENT began enrolling patients in December 2020 and is the largest trial Novocure has conducted to date. Final data from the TRIDENT trial is anticipated in 2026. The trial?s primary endpoint is overall survival.

Secondary endpoints are progression-free survival, one-year and two-year survival rate, overall radiological response, next progression-free survival, progression-free survival at six and 12 months, severity and frequency of adverse events, pathological changes in resected GBM tumors following study treatments, quality of life, dependence of overall survival on TTFields dose at the tumor, and neurological assessment using the NANO scale. Optune Gio delivers Tumor Treating Fields (TTFields) therapy to the region of the tumor.Optune Gio, previously known as Optune, is a noninvasive, antimitotic cancer treatment for glioblastoma (GBM). TTFields therapy uses electric fields to physically disrupt cell division.

TTFields therapy does not stimulate or heat tissue and targets dividing cancer cells of a specific size. TTFields therapy takes advantage of the special characteristics and geometrical shape of dividing cells, which make them susceptible to the effects of the alternating electric fields. TTFields therapy causes minimal damage to healthy cells.

Mild to moderate skin irritation is the most common side effect reported. TTFields therapy is approved in certain countries for the treatment of adults with glioblastoma, malignant pleural mesothelioma and pleural mesothelioma, some of the most difficult cancer types to treat.