Phase III PANOVA-3 trial of Tumor Treating Fields met its primary endpoint, showing a statistically significant improvement in median overall survival (mOS) versus control

PANOVA-3 evaluated the use of Tumor Treating Fields (TTFields) therapy concomitantly with gemcitabine and nab-paclitaxel as a first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma. In the intent-to-treat population, patients treated with TTFields therapy concomitant with gemcitabine and nab-paclitaxel had an mOS of 16.20 months compared to 14.16 months in patients treated with gemcitabine and nab-paclitaxel alone, a statistically significant 2.0-month improvement (hazard ratio=0.819; P=0.039) (N=571). The survival rate benefit for patients treated with TTFields therapy increased over time with a 13% improvement in the overall survival rate at 12 months and a 33% improvement in survival rate at 24 months. TTFields therapy was well-tolerated, and safety was consistent with prior clinical studies.

“There are approximately 134,000 new cases of pancreatic cancer diagnosed annually in China, and this cancer is one of the most challenging to treat globally, with limited effective treatment options and poor survival outcomes,” said Dr. Rafael Amado, M.D., President, Head of Global Research and Development at Zai Lab. “Demonstrating a statistically significant and clinically meaningful improvement in overall survival for patients with unresectable, locally advanced pancreatic cancer is an important achievement. We are pleased to have been able to contribute to the PANOVA-3 study, and we look forward to working with Novocure to bring this therapy to patients as soon as possible.”

Novocure plans to file for regulatory approval of TTFields in unresectable, locally advanced pancreatic adenocarcinoma based on PANOVA-3 and plans to submit the PANOVA-3 results for presentation at an upcoming medical congress. Zai Lab plans to file for regulatory approval in China.

About PANOVA-3; PANOVA-3 is a prospective, randomized open-label, controlled Phase III clinical trial designed to test the efficacy and safety of Tumor Treating Fields (TTFields) therapy used concomitantly with gemcitabine and nab-paclitaxel, as a first-line treatment of locally advanced pancreatic adenocarcinoma. Patients were randomized to receive either TTFields therapy concomitant with gemcitabine and nab-paclitaxel or gemcitabine and nab-paclitaxel alone. The primary endpoint is overall survival. Secondary endpoints include progression free survival, local progression free survival, objective response rate, one-year survival rate, quality of life, pain-free survival, puncture-free survival, resectability rate, and toxicity.. A total of 571 patients were enrolled in the study, randomized 1:1 and followed for a minimum of 18 months.