Novocure Announces Topline Data from the Phase 3 TRIDENT Trial Evaluating Earlier Use of Tumor Treating Fields Therapy in Newly Diagnosed Glioblastoma
The Phase 3 TRIDENT trial enrolled patients with glioblastoma prior to the initiation of chemoradiation and evaluated the benefit of initiating Tumor Treating Fields (TTFields) therapy at the start of chemoradiation compared to initiating TTFields therapy in the maintenance phase
TRIDENT did not meet its primary endpoint of demonstrating a statistically significant increase in overall survival for patients in the intent-to-treat (ITT) population who initiated TTFields therapy at the start of chemoradiation
Results from TRIDENT demonstrated a durable survival benefit for patients in both arms of the trial, no new safety signals were observed, and early initiation of TTFields therapy was feasible
The results from TRIDENT have been accepted for presentation at the American Society for Radiation Oncology (ASTRO) 2026 Annual Meeting
Novocure (NASDAQ:NVCR) announced topline results today from its Phase 3 TRIDENT trial, which evaluated the initiation of Tumor Treating Fields (TTFields) therapy for newly diagnosed glioblastoma (GBM) at the start of chemoradiation (Early Start Arm) compared to initiating TTFields therapy during the subsequent maintenance phase of treatment (Maintenance Start Arm).
The trial did not demonstrate a statistically significant improvement in the primary endpoint of overall survival for the Early Start Arm compared to the Maintenance Start Arm. In the intent-to-treat (ITT) population, the Early Start Arm had a median overall survival of 17.7 months compared to 17.5 months in the Maintenance Start Arm (HR 0.953; p=0.519).
"TRIDENT represents the largest glioblastoma trial focused on optimizing the integration of Tumor Treating Fields therapy into standard chemoradiotherapy," said Wenyin Shi, MD, PhD, Professor of Radiation Oncology, Co-Director of the Jefferson Brain Tumor Center at Sidney Kimmel Comprehensive Cancer Center, Thomas Jefferson University. "Although the study did not meet its primary endpoint, it reaffirmed the clinical value of Tumor Treating Fields therapy and demonstrated promising signals that earlier initiation of TTFields treatment may improve outcomes for selected patients."
The survival results in the ITT population in both study arms were durable over a long-term period with the one-, two-, and three-year survival rates in the Early Start Arm achieving 70.9%, 33.9% and 22.5%, respectively. In the Maintenance Start Arm, the survival rates were 72.0%, 31.6% and 18.4%, respectively.
TRIDENT enrolled 981 patients who were randomized shortly after surgery, including those who experienced clinical or radiographic deterioration during chemoradiation therapy. Approximately 25% of patients did not initiate the maintenance phase across both arms of the trial. The median patient age was 60 years. Baseline characteristics of the patient population were balanced across both arms of the trial and included: 38% of patients with a KPS of 70 or 80; 39% with a methylated MGMT promoter and 5% had IDH-mutant tumors. The extent of surgical resection was also balanced across arms, 51% of patients had a gross total resection, 37% a partial resection, and 12% biopsy only.
"We are committed to improving the treatment of glioblastoma and are grateful to our investigators and the patients and families who made the TRIDENT trial possible," said Uri Weinberg, MD, PhD, Chief Medical and Innovation Officer, Novocure. "The study did not meet its primary endpoint, but the results from TRIDENT demonstrated the feasibility and safety of initiating Tumor Treating Fields therapy during chemoradiation. We look forward to sharing additional analyses from this trial, which may inform future treatment approaches for patients with specific characteristics."
TTFields therapy, including initiation with chemoradiation, was well-tolerated, and did not lead to any new safety signals. Device related safety was consistent with prior clinical studies of TTFields therapy in GBM.
About TRIDENT
TRIDENT is a Phase 3 global, pivotal, randomized, open-label, two-arm, multicenter trial designed to evaluate the effectiveness and safety of Tumor Treating Fields (TTFields) therapy given concomitantly with chemoradiation (radiation therapy and temozolomide), for newly diagnosed glioblastoma patients, compared to initiating TTFields therapy once chemoradiation therapy is complete. In both arms, TTFields therapy and maintenance temozolomide are continued following chemoradiation therapy.
The primary endpoint of the study is overall survival. Secondary endpoints include progression-free survival, one-, two- and three-year survival rates, overall radiologic response (ORR) based on the 2010 Response Assessment in Neuro-Oncology (RANO) criteria, next progression-free survival based on the 2010 RANO criteria, and progression-free survival at 6 months and 12 months, and the severity and frequency of adverse events.
RANO guidelines are an international, multidisciplinary set of recommendations designed to standardize the evaluation of treatment response in clinical trials for brain tumors.
About Tumor Treating Fields
Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these multi-mechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and it demonstrated enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors.
To learn more about TTFields therapy and its multifaceted effect on cancer cells, visit novocure.com/ttfields.
About Novocure
Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields. Novocure's commercialized products are approved in certain countries for the treatment of adult patients with glioblastoma, pancreatic cancer, non-small cell lung cancer, malignant pleural mesothelioma and pleural mesothelioma. Novocure has several additional ongoing or completed clinical trials exploring the use of Tumor Treating Fields therapy in the treatment of glioblastoma, non-small cell lung cancer and pancreatic cancer.
Novocure's global headquarters is located in Baar, Switzerland, with U.S. headquarters located in Portsmouth, New Hampshire and research and development facilities located in Haifa, Israel. For additional information about the company, please visit Novocure.com and follow @Novocure on LinkedIn and X (Twitter).
Forward-Looking Statements
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure's current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, clinical study progress, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, coverage, collections from third-party payers and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "could" "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. Novocure's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, environmental, regulatory and political conditions and other more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on February 26, 2026, and subsequent filings with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260618609714/en/
Investors:
Adam Daney
investorinfo@novocure.com
Media:
Catherine Falcetti
media@novocure.com