On Monday, Novocure (NASDAQ: NVCR) experienced a significant surge in stock price, climbing 19%, following the announcement of successful results from its Phase 3 PANOVA-3 clinical trial. The trial, which focused on the company's Tumor Treating Fields (TTFields) therapy for pancreatic cancer, met its primary endpoint by showing a statistically significant improvement in overall survival for patients with unresectable, locally advanced pancreatic adenocarcinoma when treated with TTFields in conjunction with gemcitabine and nab-paclitaxel.
The PANOVA-3 trial's positive outcome is a milestone for Novocure, as it marks the first Phase 3 trial to demonstrate a statistically significant benefit in overall survival specifically in unresectable, locally advanced pancreatic cancer. This is also Novocure's third positive Phase 3 clinical trial result within the last two years. The company has expressed its intention to seek regulatory approvals in the U.S., EU, Japan, and other key markets based on these findings.
Patients involved in the intent-to-treat population of the trial showed a median overall survival (mOS) of 16.20 months when treated with the TTFields therapy, compared to 14.16 months for those who received the standard treatment without TTFields, representing a 2.0-month improvement. This result was supported by a 13% improvement in the overall survival rate at 12 months and a 33% improvement at 24 months. The safety profile of TTFields therapy was consistent with prior clinical studies, indicating that it was well-tolerated by patients.
The full results from the PANOVA-3 trial are expected to be presented at an upcoming medical congress, offering the medical community a comprehensive look at the data. The anticipation for these results is high, as the trial represents a potential advancement in the treatment of a particularly challenging form of cancer.
In addition to the PANOVA-3 trial, Novocure is conducting the Phase 2 PANOVA-4 trial, which is investigating TTFields therapy in combination with atezolizumab, gemcitabine, and nab-paclitaxel for the treatment of metastatic pancreatic cancer. The PANOVA-4 trial has completed enrollment, and its data is anticipated to be released in 2026.
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