Novocure’s tumor-targeting electric fields (ETFs) therapy failed to meet its key endpoint in a late-stage clinical trial of patients with glioblastoma.
The Swiss medtech’s product has FDA approval as Optune Gio. The use of the device is licensed in combination with temozolomide in newly diagnosed supratentorial glioblastoma, after the completion of radiation therapy with concomitant standard-of-care chemotherapy. It is a wearable, portable medical device that provides Tumor Treating Fields (TTFields).
Novocure was testing its tech in the new phase 3 trial, Trident, for newly diagnosed glioblastoma therapy that is administered at the beginning of chemoradiation and comparing it with initiation of TTFields therapy in the maintenance phase of therapy.
The trial did not, however, demonstrate a statistically significant advantage with the primary endpoint of overall survival versus the maintenance arm. For the overall population, there was a median overall survival of 17.7 months in the early start arm and 17.5 months in the maintenance arm, with the p-value just missing the definition of significance (p=0.519).
Glioblastoma is an extremely aggressive type of brain cancer that has limited treatment with drugs and a dismal 5-year survival rate of approximately 5% to 7%. In a statement, Novocure Chief Medical and Innovation Officer, Dr. Uri Weinberg said, “We are dedicated to enhancing the treatment of glioblastoma and are grateful our investigators were able to make the TRIDENT trial possible, as were the patients and families who participated.”
The study failed to meet its primary endpoint; however, analyses from TRIDENT showed the feasibility and safety of starting Tumor Treating Fields therapy during chemoradiation and will be shared in the near future, which could pave the way to new treatment options for certain patients.
It comes four months after the FDA approved Novocure’s device (named Optune Pax) for use in a new setting in patients with advanced pancreatic cancer with the drugs gemcitabine and nab-paclitaxel. The stock of the company dropped almost 25% in premarket trading on Thursday morning due to the news.
Novocure has announced that its investigational medical device did not achieve its primary objective of extending overall survival for patients with brain cancer in a Phase 3 clinical trial. The outcome represents a setback for Novocure, which has focused on developing innovative therapies using Tumor Treating Fields (TTFields) technology to combat difficult-to-treat cancers.
Although the trial did not meet its main endpoint, Novocure emphasized that the study generated valuable clinical data that will help guide future research and treatment strategies.
Novocure Device Misses Primary Survival Endpoint
The Phase 3 study evaluated whether the Novocure device could improve overall survival when used alongside existing standards of care for patients with brain cancer. According to the reported findings, the treatment did not demonstrate a statistically significant survival benefit compared with the control group.
Despite the disappointing result, Novocure noted that the device maintained a safety profile consistent with previous studies, providing researchers with additional insights into the therapy’s clinical performance.
