Novocure (Novocure (NVCR)) had a rough Thursday. The company announced that its Phase 3 TRIDENT study, which tested whether starting Tumor Treating Fields (TTFields) therapy earlier in the treatment timeline could improve survival for patients with newly diagnosed glioblastoma (GBM), didn't hit its primary goal.
The trial compared two groups: an Early Start Arm, where patients began TTFields therapy alongside chemoradiation, and a Maintenance Start Arm, where treatment started later during the maintenance phase. The hope was that earlier intervention would give patients a better shot at longer survival. But the data told a different story.
No Statistically Significant Difference In Overall Survival
The primary endpoint—overall survival—showed no meaningful difference between the two arms. In the intent-to-treat population, patients in the Early Start Arm had a median overall survival of 17.7 months, compared with 17.5 months in the Maintenance Start Arm. The hazard ratio was 0.953, and the p-value came in at 0.519—nowhere near statistical significance.
For context, TTFields therapy uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and causing cancer cells to die. It's already approved for use in GBM during the maintenance phase, but the idea behind TRIDENT was to see if starting it earlier, during chemoradiation, could make a bigger difference.
Long-Term Survival Outcomes Remained Durable
While the headline numbers were disappointing, the long-term survival rates were fairly similar between the two groups. In the Early Start Arm, one-, two-, and three-year survival rates were 70.9%, 33.9%, and 22.5%, respectively. In the Maintenance Start Arm, those figures were 72.0%, 31.6%, and 18.4%. Not a huge gap, but the trend slightly favored early start at the two- and three-year marks.
The trial enrolled 981 patients shortly after surgery. Notably, about a quarter of participants across both arms didn't make it to the maintenance phase of treatment, which could have influenced the results.
Safety Profile Consistent With Prior Studies
Dr. Uri Weinberg, Novocure's chief medical and innovation officer, acknowledged the miss but highlighted the positive safety data. "Although the trial missed its primary endpoint, the results demonstrated the feasibility and safety of starting TTFields therapy during chemoradiation," he said. He added that further analyses may help identify treatment approaches for patients with specific characteristics.
TTFields therapy was generally well tolerated, even when initiated during chemoradiation, and no new safety signals emerged. Device-related safety findings were consistent with previous TTFields studies in glioblastoma.
This isn't the only recent news for Novocure. In February, the FDA approved Optune Pax for the treatment of locally advanced pancreatic cancer—the first new treatment for that disease in almost 30 years. Optune Pax is a portable device that delivers TTFields noninvasively through wearable arrays and is approved for use with gemcitabine and nab-paclitaxel chemotherapy.
But for now, the brain cancer setback is what's on investors' minds. Novocure shares were down 18.89% at $14.46 at the time of publication on Thursday, according to market data.
