Novocure (NASDAQ: NVCR) announced that its pivotal Phase 3 PANOVA-3 trial successfully met its primary endpoint, showing a statistically significant improvement in median overall survival (mOS) compared to the control arm. The trial assessed the combination of Tumor Treating Fields Therapy (TTFields) with gemcitabine and nab-paclitaxel as a first-line treatment for unresectable locally advanced pancreatic cancer.
“We are thrilled that the PANOVA-3 trial has met its primary endpoint, marking a significant achievement in the fight against pancreatic cancer,” said Dr. Vincent Picozzi, medical oncologist and principal investigator of the PANOVA-3 trial. “This result is a landmark moment, especially for patients with this difficult-to-treat cancer, and the data for Tumor Treating Fields (TTFields) therapy are very promising.”
In the intent-to-treat (ITT) population, patients who received TTFields therapy in combination with gemcitabine and nab-paclitaxel experienced a statistically significant improvement in median overall survival (mOS), with a gain of 2.0 months (hazard ratio=0.819, P =0.039). Patients in the control group, treated with gemcitabine and nab-paclitaxel alone, had a median survival of 14.16 months (N=571). The overall survival benefit with TTFields therapy grew over time, showing a 13% improvement at 12 months and a 33% improvement at 24 months. TTFields therapy was well-tolerated, and its safety profile was consistent with previous studies.
“PANOVA-3 is the first and only Phase 3 trial to demonstrate a statistically significant survival benefit in patients with unresectable, locally advanced pancreatic cancer, and it is the third successful Phase 3 trial conducted by Novocure in the past two years,” said Dr. Nicholas Lupin, Novocure’s Chief Medical Officer. “We thank all the patients and investigators involved and look forward to presenting the full data at an upcoming medical conference.”
Novocure plans to submit regulatory applications for TTFields therapy in the treatment of unresectable locally advanced pancreatic cancer based on these promising results and will present the PANOVA-3 data at a future medical conference.
Additionally, Novocure continues its investigation of TTFields therapy in the ongoing Phase 2 PANOVA-4 trial, which is studying its combination with atezolizumab, gemcitabine, and nab-paclitaxel for metastatic pancreatic cancer. Enrollment is complete, with results expected in 2026.
About PANOVA-3
The PANOVA-3 trial is a Phase 3, randomized, open-label study assessing the safety and efficacy of Tumor Treating Fields therapy (TTFields) in combination with gemcitabine and nab-paclitaxel for patients with locally advanced pancreatic adenocarcinoma. The trial’s primary endpoint is overall survival, with secondary endpoints including progression-free survival, response rate, and quality of life. A total of 571 patients were enrolled and followed for at least 18 months.
About PANOVA-4
PANOVA-4 is a Phase 2, international, multicenter trial evaluating the combination of Tumor Treating Fields therapy, atezolizumab, gemcitabine, and nab-paclitaxel for metastatic pancreatic cancer. The trial’s primary endpoint is disease control rate, with secondary endpoints including overall survival, progression-free survival, and toxicity. The study aims to enroll 76 patients.
About Pancreatic Cancer
Pancreatic cancer is one of the deadliest cancers and the third leading cause of cancer-related death in the U.S. With approximately 67,000 new cases annually, it has a poor prognosis, with a 5-year survival rate of only 13%. Most cases are diagnosed at an inoperable stage, making chemotherapy the primary treatment option.
About Tumor Treating Fields Therapy
Tumor Treating Fields (TTFields) therapy uses electric fields to disrupt cancer cell division, selectively targeting and killing cancer cells while sparing healthy ones. TTFields therapy has demonstrated efficacy in treating glioblastoma, non-small cell lung cancer, malignant pleural mesothelioma, and is being investigated in other cancers, including pancreatic cancer.
About Novocure
Novocure is a global oncology company focused on extending survival for patients with aggressive cancers through Tumor Treating Fields therapy (TTFields). Novocure’s therapies are approved in several countries for the treatment of glioblastoma, non-small cell lung cancer, and malignant pleural mesothelioma, with ongoing trials for other cancers including pancreatic cancer.
