Novocure announced positive topline results from its Phase 3 PANOVA-3 clinical trial, revealing that Tumor Treating Fields (TTFields) therapy, when combined with gemcitabine and nab-paclitaxel, significantly improved overall survival (OS) in patients with unresectable, locally advanced pancreatic adenocarcinoma. The study's success has paved the way for regulatory submissions in the US, EU, Japan, and China, potentially offering a new treatment option for this challenging disease.
The PANOVA-3 trial (NCT03377491), a randomized, open-label study, enrolled 571 patients who were randomized 1:1 to either TTFields therapy plus gemcitabine and nab-paclitaxel or gemcitabine and nab-paclitaxel alone. The primary endpoint was overall survival.
Significant Improvement in Overall Survival
The results demonstrated a statistically significant improvement in median overall survival (mOS) for patients treated with TTFields therapy in combination with chemotherapy. The mOS was 16.20 months in the TTFields arm compared to 14.16 months in the chemotherapy-only arm (HR, 0.819; P = 0.039). This translated to a 13% improvement in the overall survival rate at 12 months and a 33% improvement at 24 months for patients receiving TTFields therapy.
"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, M.D., PhD, Chief Medical Officer, Novocure.
TTFields: A Novel Approach to Cancer Treatment
TTFields therapy utilizes electric fields to exert physical forces on cancer cells, disrupting their division and potentially leading to cell death. Unlike traditional therapies, TTFields do not significantly affect healthy cells due to differences in properties such as division rate, morphology, and electrical characteristics. The therapy is delivered through a portable device placed on the skin near the tumor.
Regulatory Pathway and Future Studies
Based on the PANOVA-3 results, Novocure plans to file for regulatory approval in the US, EU, Japan, and other key markets. Zai Lab, Novocure's partner, intends to file for approval in China.
Novocure is also conducting the Phase 2 PANOVA-4 trial (NCT06390059), which is evaluating TTFields therapy in combination with atezolizumab, gemcitabine, and nab-paclitaxel for metastatic pancreatic cancer, with data expected in 2026.
Impact on Pancreatic Cancer Treatment
Pancreatic cancer remains one of the most lethal cancers, with a five-year survival rate of approximately 13% in the United States. The PANOVA-3 trial offers hope for patients with locally advanced disease, where surgery is not an option. The addition of TTFields therapy to standard chemotherapy could potentially extend survival and improve outcomes for this patient population.
