The pivotal trial met its primary endpoint, demonstrating a statistically significant improvement in median overall survival (mOS) versus control.
In the intent-to-treat population, patients treated with TTFields therapy concomitant with gemcitabine and nab-paclitaxel had an mOS of 16.20 months compared to 14.16 months in patients treated with gemcitabine and nab-paclitaxel alone, a statistically significant 2.0-month improvement (hazard ratio=0.819; P=0.039) (N=571).
The survival rate benefit for patients treated with TTFields therapy increased over time, with a 13% improvement in the overall survival rate at 12 months and a 33% improvement in survival rate at 24 months.
TTFields therapy was well-tolerated, and safety was consistent with prior clinical studies. Novocure plans to file for regulatory approval in the U.S., EU, Japan and other key markets. Zai Lab plans to file for regulatory approval in China.
Novocure continues to follow patients in its Phase 2 PANOVA-4 trial, which is exploring the use of TTFields therapy together with atezolizumab, gemcitabine, and nab-paclitaxel for the treatment of metastatic pancreatic cancer. PANOVA-4 has completed enrollment, and data are anticipated in 2026.
Price Action: NVCR stock is up 31% at $26.26 at last check Monday.
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