On Monday, NovoCure Ltd ( NVCR ) and Zai Lab Limited ( ZLAB ) revealed topline data from the Phase 3 PANOVA-3 trial of Tumor-Treating Fields (TTFields) therapy concomitantly with gemcitabine and nab-paclitaxel as a first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma.
The pivotal trial met its primary endpoint, demonstrating a statistically significant improvement in median overall survival (mOS) versus control.
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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 ( NVCR ) plans to file for regulatory approval in the U.S., EU, Japan and other key markets. Zai Lab ( ZLAB ) plans to file for regulatory approval in China.
Novocure ( NVCR ) 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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