Novocure Ltd. (NASDAQ:NVCR) on Thursday reported topline results from its Phase 3 TRIDENT study.
The data showed that starting Tumor Treating Fields (TTFields) therapy during chemoradiation did not significantly improve overall survival compared with initiating the therapy during the maintenance phase in patients with newly diagnosed glioblastoma (GBM).
The study evaluated an Early Start Arm, in which TTFields therapy began alongside chemoradiation, against a Maintenance Start Arm, where treatment was initiated later during maintenance therapy.
Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and causing cancer cells to die.
No Statistically Significant Difference In Overall Survival
The trial failed to meet its primary endpoint of improving overall survival. In the intent-to-treat population, patients in the Early Start Arm achieved a median overall survival of 17.7 months, compared with 17.5 months in the Maintenance Start Arm.
The results yielded a hazard ratio of 0.953 and a p-value of 0.519.
Long-Term Survival Outcomes Remained Durable
Survival outcomes remained durable in both treatment groups over the long term. One-, two-, and three-year survival rates in the Early Start Arm were 70.9%, 33.9%, and 22.5%, respectively.
In the Maintenance Start Arm, the corresponding rates were 72.0%, 31.6%, and 18.4%.
TRIDENT enrolled 981 patients shortly after surgery. About one-quarter of participants across both study arms did not enter the maintenance phase of treatment.
Safety Profile Consistent With Prior Studies
Dr. Uri Weinberg, Novocure’s chief medical and innovation officer, said that although the trial missed its primary endpoint, the results demonstrated the feasibility and safety of starting TTFields therapy during chemoradiation.
He added that further analyses may help identify treatment approaches for patients with specific characteristics.
TTFields therapy was generally well tolerated, including when initiated during chemoradiation, and no new safety signals were observed. Device-related safety findings were consistent with previous TTFields studies in glioblastoma.
In February, the FDA approved Optune Pax for the treatment of locally advanced pancreatic cancer — marking the first new treatment for the disease in almost 30 years.
Optune Pax is a portable therapeutic device that delivers TTFields noninvasively through wearable arrays and is approved for use with gemcitabine and nab-paclitaxel chemotherapy.
NVCR Stock Price Activity: NovoCure shares were down 18.89% at $14.46 at the time of publication on Thursday, according to Benzinga Pro data.
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