Novocure has cleared a phase 3 clinical study in pancreatic cancer, showing its tumor-treating electric fields could help against the notoriously recalcitrant disease.
The company’s wearable therapy improved overall survival as part of a first-line regimen for patients with inoperable pancreatic adenocarcinoma, one of the most lethal cancers.
Novocure said the results of the trial, known as PANOVA-3, will form the basis of submissions for regulatory approvals in the U.S., the EU, Japan and other international markets. The news sent the company's stock price up more than 50%, to about $30 per share, and comes on the heels of an FDA green light for its approach in metastatic non-small cell lung cancer in October.
“PANOVA-3 is the first and only Phase 3 trial to demonstrate a statistically significant benefit in overall survival specifically in unresectable, locally advanced pancreatic cancer, and is Novocure’s third positive phase 3 clinical trial in the last two years,” Chief Medical Officer Nicolas Leupin said in a statement.
Delivered through pads worn over the skin, the high-frequency, electric field-based therapies aim to physically interfere with the charged structures inside cancer cells as they reproduce, which aids the immune system in responding to the tumor.
In the study, patients underwent therapy with the company’s Tumor Treating Fields alongside gemcitabine and nab-paclitaxel, and were compared to those who received the chemotherapy combination alone. TTFields demonstrated a median overall survival of 16.20 months, for a statistically significant improvement over the 14.16 months seen in the control arm.
The company also said that TTFields’ survival benefit increased over time, with a 13% improvement in overall survival after one year, and 33% after two years. The device therapy was well-tolerated and in line with previous clinical studies. Novocure said it plans to present the trial’s full findings at an upcoming medical congress.
A separate phase 2 study, PANOVA-4, will examine TTFields combined with a triplet regimen of gemcitabine, nab-paclitaxel and atezolizumab and will test their ability to control metastatic pancreatic cancer. It has completed enrollment and the company said it expects to have data in 2026.
Novocure’s TTFields-powered Optune therapies have also been approved by the FDA for glioblastoma and mesothelioma. In mid-2023, a phase 3 trial exploring their use in ovarian cancer failed to meet its primary endpoint, given alongside paclitaxel in platinum-resistant disease.