Novocure announced Optune Pax received CE Mark for locally advanced pancreatic cancer after PANOVA-3 showed a survival benefit.
Key Highlights:
- CE Mark granted for Optune Pax to treat adult locally advanced pancreatic cancer with gemcitabine and nab-paclitaxel per guideline recommendations.
- PANOVA-3 (n=571) showed mOS improvement: ITT 16.2 vs 14.2 months (HR 0.82, p=0.039), a 2.0-month benefit.
- mITT analysis showed mOS 18.3 vs 15.1 months (HR 0.77, p=0.023), a 3.2-month improvement for treated patients.
- Optune Pax significantly extended median time to pain progression by 6.1 months (15.2 vs 9.1 months; HR 0.74, p=0.027).
- Device was well tolerated with mainly mild-to-moderate skin AEs; no device-related deaths or new safety signals observed.
Original SEC Filing:
This is an AI-powered summary. It may contain inaccuracies. Consider verifying important information with the source. Please note this summary is solely based on documents filed with the SEC.