Novocure’s tumor-treating electric fields device missed its primary endpoint in a late-stage glioblastoma trial.
The Swiss medtech’s product has an FDA approval as Optune Gio. The device is licensed alongside temozolomide for newly diagnosed, supratentorial glioblastoma following maximal debulking surgery, and completion of radiation therapy together with concomitant standard of care chemotherapy.
It works as a portable, wearable medical device by delivering Tumor Treating Fields (TTFields).
In the new phase 3 trial, known as Trident, Novocure was testing its tech in newly diagnosed glioblastoma, to be used at the start of chemoradiation, and comparing it to initiating TTFields therapy during the subsequent maintenance phase of treatment.
The trial, however, failed to show a statistically significant improvement in the primary endpoint, which was overall survival compared to the maintenance arm.
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In the intent-to-treat population, the early start arm had a median overall survival of 17.7 months, while the maintenance arm saw 17.5 months, with the p-value just falling out of range of significance (p=0.519).
Glioblastoma is an aggressive brain cancer with few drug treatment options and a woeful five-year survival rate of around 5% to 7%.
“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, M.D., Ph.D., Chief Medical and Innovation Officer at Novocure, in a statement.
“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.”
The outcome arrives four months after the FDA gave the go-ahead to Novocure for its device in a new setting, where it is called Optune Pax, in patients with advanced pancreatic cancer in conjunction with the drugs gemcitabine and nab-paclitaxel.
Shares in the company fell nearly 25% in premarket trading Thursday morning on the latest news.
