Novocure’s stock has dropped more than 15% after its Phase III glioblastoma study of Optune Gio failed to show benefit when used at an earlier stage.
The Phase III TRIDENT trial (NCT04471844) evaluated the initiation of Tumour Treating Fields (TTFields) therapy, Optune Gio, for newly diagnosed glioblastoma at the start of chemoradiation (early start arm) compared to initiating Optune Gio therapy during the maintenance phase (maintenance start arm).
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Optune Gio is an already approved medical device for the treatment of glioblastoma multiforme in adult patients.
The trial did not demonstrate a statistically significant improvement in the primary endpoint of overall survival (OS) for the early arm compared to the maintenance arm. In the intent-to-treat (ITT) population, the early start arm had a median overall survival (OS) of 17.7 months compared to 17.5 months in the maintenance arm.
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.
Following the data release, Novocure’s stock, listed on the Nasdaq exchange, dropped 16.5% from $17.85 at close on 17 June to $14.90 at open on 18 June. The Swiss company has a market cap of $1.66bn.
Dr Wenyin Shi, Professor of Radiation Oncology, co-director of the Jefferson Brain Tumor Center at Sidney Kimmel Comprehensive Cancer Center, Thomas Jefferson University, said: “TRIDENT represents the largest glioblastoma trial focused on optimising the integration of TTFields therapy into standard chemoradiotherapy. Although the study did not meet its primary endpoint, it reaffirmed the clinical value of TTFields therapy and demonstrated promising signals that earlier initiation of TTFields treatment may improve outcomes for selected patients.”
TRIDENT enrolled 981 patients who were randomised 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.
Optune Gio, 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 the device in GBM.
TTFields was originally approved by the US Food and Drug Administration (FDA) in 2011. It is a non-invasive cancer therapy that uses alternating electric fields to disrupt the rapid division of cancer cells. Patients wear a portable, battery-operated device that delivers these fields through adhesive transducer arrays placed directly on the skin near the tumour site.
In 2024, Novocure gained clearance from the FDA for the new head flexible electrode (HFE) transducer arrays for use with Optune Gio. The wearable’s HFEs have been modified to be more comfortable for patients using them for treatment.
Novocure’s Optune Pax device for locally advanced pancreatic cancer treatment obtained FDA clearance in February 2026, representing the first new therapy approved by the agency in this indication since Eli Lilly’s Gemzar (gemcitabine) chemotherapy drug in 1996. Pancreatic cancer has historically been extremely difficult to treat, with OS rate remaining low.
