Final Participant Registered in TRIDENT Phase 3 Glioblastoma Trial

The final patient has been enrolled in the TRIDENT phase 3 clinical trial, which is assessing the safety and efficacy of Optune Gio® in conjunction with radiation therapy and temozolomide for adult patients with newly diagnosed glioblastoma (GBM). The trial, which began in December 2020, is the largest conducted by Novocure and aims to enroll 950 participants. Optune Gio® is a noninvasive treatment that uses Tumor Treating Fields (TTFields) to disrupt cell division in cancer cells. The therapy has been shown in preclinical research to have a more pronounced cytotoxic effect when used with radiation therapy compared to its use afterward.

The TRIDENT study is designed to determine if initiating TTFields therapy at the same time as radiation therapy and temozolomide can lead to improved outcomes for GBM patients. The primary endpoint of the trial is overall survival, with secondary endpoints including progression-free survival, one-year and two-year survival rates, and quality of life measures. The final data from the trial is expected in 2026.

Optune Gio® is currently approved for use alongside maintenance temozolomide for the treatment of newly diagnosed GBM following surgery and radiation therapy completion. The therapy works by targeting dividing cancer cells with specific electric field frequencies, causing minimal damage to healthy cells. The most common side effects are mild to moderate skin irritation.

Novocure, headquartered in Switzerland, is a global oncology company focused on extending survival in aggressive cancer forms through the development and commercialization of TTFields therapy. The company's products are approved in certain countries for treating GBM, malignant pleural mesothelioma, and other challenging cancer types. Novocure continues to investigate TTFields in various cancers, including brain metastases, gastric cancer, liver cancer, non-small cell lung cancer, pancreatic cancer, and ovarian cancer.

Important safety information for Optune Gio® includes contraindications for patients with active implanted medical devices, skull defects, or bullet fragments, as well as warnings for pregnant women or those who may become pregnant. The most common adverse events associated with Optune Gio® in combination with temozolomide are thrombocytopenia, nausea, constipation, vomiting, fatigue, and others. The company advises caution in patients with serious underlying skin conditions on the scalp, as this may affect treatment.