Swiss oncology specialist Novocure has announced positive topline results from the PANOVA-3 phase 3 clinical trial, which evaluated the use of tumor treating fields (TTFields) therapy in combination with the chemotherapy drugs gemcitabine and nab-paclitaxel. The trial met its primary endpoint of a significant improvement in median overall survival in patients with unresectable, locally advanced pancreatic adenocarcinoma.
Breakthrough in pancreatic cancer treatment
Based on these results, Novocure intends to file for regulatory approval in the US, EU, and Japan, among other markets, of the combination therapy as a first-line treatment for this particular cancer indication.
“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,” said Nicolas Leupin, Chief Medical Officer of Novocure.
Tumor treating fields therapy employs electric fields to kill cancer cells by exerting physical force onto them. Because of the different properties of cancer cells and healthy cells, these electric fields do not significantly affect healthy cells. This form of therapy can be used to enhance the effects of cancer treatments, such as chemotherapy, radiotherapy, and checkpoint inhibitors, in solid tumors.
Novocure plans global filings
The TTFields delivery system developed by Novocure, consisting of a device that delivers high-frequency electric fields through the skin, has been previously approved by the FDA for the treatment of glioblastoma and mesothelioma tumors.
Results from the PANOVA-3 trial showed that the addition of TTFields to treatment with gemcitabine and nab-paclitaxel increased the median overall survival from 14.2 to 16.2 months compared to the chemotherapy drugs alone. This improvement in survival rate increased over time, with a 13% improvement at the 12-month time point and a 33% improvement at 24 months.
“As a researcher and clinician, I have experienced the challenges of developing treatments in pancreatic cancer. It is exciting to see the PANOVA-3 trial achieve the positive primary endpoint of overall survival, a landmark outcome for this field,” said Vincent Picozzi, medical oncologist and investigator in the PANOVA-3 trial. “These data for tumor treating fields are very promising, especially in this difficult to treat patient population.”
Novocure is currently running an additional phase 2 clinical trial, named PANOVA-4, following patients with metastatic pancreatic cancer treated with TTFields in combination with gemcitabine and nab-paclitaxel, as well as with the checkpoint inhibitor atezolizumab. Results from the ongoing trial are expected in 2026.
