A Phase III trial of a wearable electric field treatment for advanced pancreatic cancer, developed by Swiss biotech Novocure, met its primary endpoint and significantly improved patient survival time.
These results are important, as this kind of cancer is notoriously difficult to treat so even small improvements in patient outcomes are notable.
“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, MD, medical oncologist and investigator in the trial, in a press statement.
Alternating electric field, or tumor treating fields therapy, was developed by Novocure founder Yoram Palti, MD, PhD, a professor emeritus of physiology and biophysics at the Technion-Israel Institute of Technology.
Palti’s work showed that alternating electric fields have the potential to disrupt cancer cell division in solid tumors and was the basis of the wearable technology, delivered through pads attached to the skin, developed by Novocure (e.g., Optune Gio and Optune Lua). This therapy has been approved as an add-on treatment for newly diagnosed and recurrent glioblastoma, non-small cell lung cancer, and mesothelioma.
The PANOVA-3 trial included 557 patients with unresectable, locally advanced pancreatic adenocarcinoma who were treated with gemcitabine or nab-paclitaxel (controls) or either of these drugs plus use of Novocure’s wearable tumor treating fields device (treatment group).
Median overall survival was 16.20 months in the treatment group versus 14.16 in the control group, a statistically significant difference. The survival benefit appeared to increase over time with a 13% improvement in overall survival at 12 months in the treatment group compared with a 33% improvement at 24 months.
“PANOVA-3 is the first and only Phase III trial to demonstrate a statistically significant benefit in overall survival specifically in unresectable, locally advanced pancreatic cancer, and is Novocure’s third positive Phase III clinical trial in the last two years,” said Nicolas Leupin, chief medical officer, Novocure.
“These data for Tumor Treating Fields are very promising, especially in this difficult-to-treat patient population,” added Picozzi.
Based on the results of this trial, the company’s Nasdaq share price jumped by more than 50%. Novocure now plans to submit its device for regulatory approval to form part of a first-line combination treatment for inoperable pancreatic cancer. The company is also planning a trial in patients with metastatic pancreatic cancer.
