Zai Lab and Novocure Report Positive Phase 3 PANOVA-3 Results for TTFields Therapy in Pancreatic Cancer

Zai Lab Limited and Novocure announced that their Phase 3 PANOVA-3 trial has achieved its primary goal, showing a significant improvement in median overall survival for patients with unresectable, locally advanced pancreatic adenocarcinoma. The PANOVA-3 trial examined the effectiveness of Tumor Treating Fields (TTFields) therapy when used alongside gemcitabine and nab-paclitaxel as a first-line treatment.

Dr. Vincent Picozzi, a medical oncologist and PANOVA-3 investigator, expressed his enthusiasm about the trial's success in improving overall survival, highlighting the potential significance of TTFields in treating pancreatic cancer. In the study, patients receiving TTFields therapy in combination with the chemotherapy drugs had a median overall survival of 16.20 months, compared to 14.16 months for those who received only the chemotherapy (gemcitabine and nab-paclitaxel). This represented a statistically significant 2.0-month increase in survival. The advantages of TTFields therapy continued to grow over time, with a 13% higher survival rate at one year and a 33% higher survival rate at two years. The therapy was well-tolerated, with a safety profile consistent with previous clinical studies.

Dr. Nicolas Leupin, Chief Medical Officer at Novocure, highlighted PANOVA-3 as the first and only Phase 3 trial to demonstrate a statistically significant survival benefit in this patient group, making it Novocure's third positive Phase 3 trial in two years. Dr. Rafael Amado, President of Global Research and Development at Zai Lab, emphasized the importance of this achievement, particularly given the limited effective treatment options and poor survival outcomes for pancreatic cancer patients in China. He noted the high incidence of pancreatic cancer in China, with approximately 134,000 new cases annually, and the significant impact this trial could have on improving patient outcomes.

Novocure plans to seek regulatory approval for TTFields in treating unresectable, locally advanced pancreatic adenocarcinoma, based on the positive results from PANOVA-3. Similarly, Zai Lab intends to pursue regulatory approval in China.

PANOVA-3 was a large-scale, randomized, open-label Phase 3 trial designed to evaluate the efficacy and safety of TTFields therapy combined with gemcitabine and nab-paclitaxel versus the chemotherapy regimen alone. The primary goal was overall survival, with secondary goals including 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. The trial enrolled 571 patients, who were followed for at least 18 months.

Pancreatic cancer is recognized as one of the deadliest cancers worldwide, with particularly poor survival rates in China. In 2022, it was estimated that there were around 134,374 new cases in China, making it the eighth most common cancer type in the country. The current median survival for patients with locally advanced, unresectable pancreatic cancer is between nine and twelve months, and the five-year survival rate stands at 7.2%, the lowest among all cancers in China.

Tumor Treating Fields (TTFields) are electric fields that disrupt cancer cell division by exerting physical forces on them. Unlike cancer cells, healthy cells are largely unaffected by TTFields due to their different properties. This therapy, by targeting multiple mechanisms, enhances the effectiveness of traditional cancer treatments such as chemotherapy, radiotherapy, immune checkpoint inhibitors, and targeted therapies, offering versatility in treating a range of solid tumors.

Zai Lab focuses on innovative, research-based biopharmaceutical products, addressing significant unmet medical needs in oncology, immunology, neuroscience, and infectious diseases. Novocure is dedicated to extending survival in aggressive cancers through the development and commercialization of TTFields therapy, with ongoing and completed trials in various cancer types.