Novocure (Nasdaq:NVCR) today announced positive results from the Phase 3 PANOVA-3 trial of its tumor-treating fields (TTFields) therapy.
Investigators plan to present results today at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. They’ll simultaneously publish findings in the Journal of Clinical Oncology.
PANOVA-3 evaluates TTFields therapy concomitantly used with gemcitabine and nab-paclitaxel as a first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma — one of the most deadly forms of cancer. It compares this therapy to gemcitabine and nab-paclitaxel alone.
The trial met its primary endpoint, demonstrating a statistically significant improvement in median overall survival (mOS) with TTFields.
“Most people with pancreatic cancer are diagnosed with advanced disease, which is very difficult to treat and only about 1 in 10 people are alive five years after diagnosis,” said Nicolas Leupin, MD, PhD, Chief Medical Officer, Novocure. “The results shared today at ASCO and in the Journal of Clinical Oncology demonstrate that Tumor Treating Fields therapy improved overall survival and pain-free survival in unresectable, locally advanced pancreatic cancer. We plan to submit these data to the FDA in the second half of 2025 to support a premarket approval for Tumor Treating Fields therapy.”
More on the PANVOA-3 results shared by Novocure
In the intent-to-treat population, the TTFields arm had an mOS of 16.2 months. That compared to 14.2 months for patients treated with therapeutics alone, marking a statistically significant 2-month improvement.
TTFields demonstrated improvement in several secondary endpoints, Novocure said. Those included one-year survival rate and pain-free survival. The company said pancreatic cancer can cause significant pain as the disease progresses and managing pain represents a key clinical challenge.
One-year survival rate for TTFields came in at 68.1%, marking a statistically significant improvement. That compared to 60.2% in the therapy alone arm. Patients had a median pain-free survival of 15.2 months with TTFields, compared to a median of 9.1 months in the gemcitabine and nab-paclitaxel group.
Novocure reported quality of life measured as a secondary endpoint, with another significant improvement for TTFields. Investigators saw no statistically significant difference in additional secondary outcome measures of progression-free survival, local progression-free survival, objective response rate, puncture-free survival or tumor resectability rate. They said patients tolerated TTFields therapy well, with no new safety signals observed. Investigators reported moderate skin adverse events as the most common device-related adverse events.
“The data presented today from the PANOVA-3 trial of Tumor Treating Fields show a clinically meaningful and statistically significant improvement in overall survival for people with locally advanced pancreatic cancer,” said Dr. Vincent Picozzi, medical oncologist and investigator in the PANOVA-3 trial. “Importantly, we also saw an extension in the duration of time before pain progressed. Pain is a hallmark of this disease, and as a clinician, the potential of this therapy to address this aspect of pancreatic cancer is very encouraging.
“These results illustrate the potential of Tumor Treating Fields therapy concomitant with gemcitabine and nab-paclitaxel to become a standard of care for unresectable, locally advanced pancreatic cancer.”
