Novocure said its Optune Pax wearable device won a CE mark for adult patients with locally advanced pancreatic cancer of exocrine origin, clearing the way for use in Europe alongside gemcitabine and nab-paclitaxel.
The approval is backed by the phase 3 PANOVA-3 trial, which enrolled 571 patients and showed a median overall survival of 16.2 months for the Optune Pax group versus 14.2 months for chemotherapy alone, a 2.0-month gain. In the modified intent-to-treat population, median overall survival was 18.3 months versus 15.1 months, a 3.2-month improvement.
The device also extended time to pain progression. Median time to pain progression reached 15.2 months with Optune Pax compared with 9.1 months without it, a 6.1-month difference.
One-year survival improved in both study populations. In the intent-to-treat group, the rate was 68.1% with Optune Pax versus 60.2% with chemotherapy alone. In the modified intent-to-treat group, it was 75.2% versus 65.9%.
The company said the treatment was generally well tolerated. Device-related skin adverse events were reported in 76.3% of treated patients, mostly mild to moderate, and 7.7% experienced grade 3 or higher skin events. Fatigue was the most common non-skin device-related adverse event, reported in 5.1% of participants.
Novocure said it plans to launch Optune Pax in Germany in the coming weeks. Following these announcements, the company's shares moved -1.42%, and are now trading at a price of $15.26. Check out the company's full 8-K submission here.
