- TTFields therapy combined with gemcitabine and nab-paclitaxel demonstrates the first clinically meaningful and statistically significant improvement in overall survival (OS) for patients with unresectable, locally advanced pancreatic adenocarcinoma in a Phase 3 trial.
- The OS benefit seen with TTFields therapy is further supported by notable improvements in quality of life and prolonged, pain-free survival, crucial outcomes for patients battling pancreatic cancer.
- Results from PANOVA-3 have been accepted as a late-breaking abstract for an oral presentation at ASCO and are concurrently published in the Journal of Clinical Oncology.
SHANGHAI & CAMBRIDGE, Mass. & BAAR, Switzerland – In a significant stride for the medical community, Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) and Novocure (NASDAQ: NVCR) have announced groundbreaking results from the Phase 3 PANOVA-3 trial. The data, focusing on Tumor Treating Fields (TTFields) therapy for pancreatic cancer, will be presented today at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, with simultaneous publication in the Journal of Clinical Oncology.
“The latest data from the PANOVA-3 trial illuminates a clinically meaningful and statistically significant enhancement in overall survival for those with locally advanced pancreatic cancer,” stated Dr. Vincent Picozzi, MD, MMM, a medical oncologist and investigator in the PANOVA-3 trial. “Equally significant is the extended period before pain progression. Pain is a characteristic challenge for this devastating disease, and, as a clinician, the potential of TTFields therapy to address this is exceptionally encouraging. These results underscore the promise of TTFields therapy, when combined with gemcitabine and nab-paclitaxel, to become a standard of care for patients with unresectable, locally advanced pancreatic cancer.”
The Phase 3 PANOVA-3 trial meticulously assessed the efficacy of TTFields therapy administered alongside gemcitabine and nab-paclitaxel as an initial treatment for unresectable, locally advanced pancreatic adenocarcinoma. This approach was compared against gemcitabine and nab-paclitaxel alone. The trial successfully achieved its primary endpoint, demonstrating a statistically significant improvement in median overall survival (mOS) for patients undergoing TTFields therapy.
“The encouraging findings from the Phase 3 PANOVA-3 study provide a meaningful advance in treatment outcomes for patients with inoperable, locally advanced pancreatic cancer, notably including pain reduction and a statistically significant extension in overall survival,” commented Rafael Amado, M.D., President, Head of Global Research and Development at Zai Lab. “Pancreatic cancer remains one of the most difficult cancers globally to treat, with roughly 134,000 new diagnoses each year in China alone. Zai Lab participated in this trial and is eager to continue our collaboration with Novocure to expedite the delivery of this innovative therapy to patients within China.”
“A vast majority of pancreatic cancer patients are diagnosed with advanced disease, which is notoriously hard to treat with a five-year survival rate standing at just 10%,” said Nicolas Leupin, MD, PhD, Chief Medical Officer, Novocure. “The results unveiled today at ASCO and in the Journal of Clinical Oncology show that Tumor Treating Fields therapy has improved overall survival and pain-free survival in unresectable, locally advanced pancreatic cancer. We are preparing to submit this data to the FDA in the second half of 2025 to support premarket approval for Tumor Treating Fields therapy.”
Key Results from PANOVA-3
In the intention-to-treat cohort, patients treated with TTFields therapy alongside gemcitabine and nab-paclitaxel witnessed an mOS of 16.2 months, compared to 14.2 months for those treated with the chemotherapy combination alone. This represents a statistically significant 2.0-month boost [hazard ratio (HR) 0.82; p=0.039 (N=571)].
The therapy also demonstrated marked improvements in secondary endpoints, encompassing one-year survival rates and pain-free survival. Given the often debilitating pain associated with pancreatic cancer, managing pain progression is an extremely important facet of treatment.
- The one-year survival rate showcased a statistically significant improvement within the TTFields therapy combined with gemcitabine and nab-paclitaxel arm, with 68.1% [95% CI: 62.0–73.5], contrasting the 60.2% [95% CI: 54.2–65.7], within the gemcitabine and nab-paclitaxel-only group, with a p-value of 0.029.
- Patients receiving TTFields therapy alongside gemcitabine and nab-paclitaxel exhibited a median pain-free survival of 15.2 months [95% CI: 10.3–22.8], when compared to a median survival of 9.1 months within the group receiving only the chemotherapy [95% CI: 7.4–12.7]; HR 0.74 [95% CI: 0.56–0.97], with a p-value of 0.027. In effect, a 6.1-month extension in pain-free survival was observed. Defined as the period from the trial’s starting point until either a 20-point upswing on the patient rated pain scale or until death.
Quality of life was also analyzed as a secondary endpoint. Analyses, utilizing the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) with the added Pancreatic Cancer specific PAN26 supplement, were performed on all patients . Deterioration-free survival in global health status, pain and digestive problems were significantly improved in patients receiving TTFields therapy concomitant with gemcitabine and nab-paclitaxel compared to the gemcitabine and nab-paclitaxel alone group. A thorough report on the quality of life results of PANOVA-3 will be shared at an upcoming scientific conference.
It is worth noting that the results show no statistically significant differences in secondary outcomes like progression-free survival, local progression-free survival, objective response rate, puncture-free survival or tumor resectability between the treatment groups.
TTFields therapy was well-tolerated, with no new safety signals reported, validating the prior clinical studies . Mild to moderate skin adverse events (AEs) were the most prevalent device-related AEs.
Presentation & Publication Details
The PANOVA-3 data, (LBA 3500), a Phase 3 study on using Tumor Treating Fields (TTFields) with gemcitabine and nab-paclitaxel in patients with locally advanced pancreatic ductal adenocarcinoma (LA-PAC), is being presented today by Dr. Picozzi in Hall D1 during the 3:00 – 6:00 p.m. Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary oral session.
The Phase 3 PANOVA-3 publication in the Journal of Clinical Oncology, entitled “Tumor Treating Fields with gemcitabine and nab-paclitaxel for locally advanced pancreatic adenocarcinoma: randomized, open-label, pivotal phase 3 PANOVA-3 study,” is accessible online at https://ascopubs.org/doi/10.1200/JCO-25-00746.
Regulatory & Ongoing Clinical Study of TTFields for Pancreatic Cancer
Novocure is planning to apply for regulatory clearance for the use of TTFields therapy in cases of unresectable, locally advanced pancreatic adenocarcinoma, based on the findings of PANOVA-3 in the U.S., expected in the second half of 2025. The company also intends to pursue regulatory approvals in the EU, Japan, and other pivotal markets.
Novocure is continuing to track patient data from the Phase 2 PANOVA-4 trial. This trial is exploring the effectiveness of TTFields therapy combined with atezolizumab, gemcitabine, and nab-paclitaxel in the treatment of metastatic pancreatic cancer. PANOVA-4 has completed its enrollment, with anticipated data by the first half of 2026.
About PANOVA-3
PANOVA-3 is an international, prospective, randomized, open-label, controlled Phase 3 clinical trial aimed at evaluating the safety and efficacy of Tumor Treating Fields (TTFields) therapy used concomitantly with gemcitabine and nab-paclitaxel as a first-line treatment for locally advanced pancreatic adenocarcinoma . Participants were randomly assigned to either TTFields therapy combined with gemcitabine and nab-paclitaxel or gemcitabine and nab-paclitaxel alone.
The primary objective of the study was overall survival. Secondary endpoints included 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 PANOVA-3 study enrolled a total of 571 participants with a 1:1 randomization, with all patients followed for a minimum of 18 months.
About PANOVA-4
PANOVA-4 is an international, multi-center, Phase 2 clinical trial designed to test the safety and efficacy of Tumor Treating Fields (TTFields) therapy together with atezolizumab, gemcitabine and nab-paclitaxel for the treatment of metastatic pancreatic cancer. The primary endpoint is disease control rate. Secondary endpoints include overall survival, progression-free survival, one-year survival rate, objective response rate, progression-free survival at six months, duration of response, and toxicity. The study is designed to enroll 76 patients and enrollment is complete.
About Pancreatic Cancer in China
Pancreatic cancer stands as a global health challenge because of its prevalence. In China alone, there were an estimated 134,374 new cases diagnosed in 2022, ranking it as the eighth most widespread cancer1. The current median survival rate for people with locally advanced, unresectable pancreatic cancer is around nine to twelve months, with the five-year survival rate at about 7.2%2. This makes it the cancer with the lowest survival rate within China.
1 Xia C, Dong X, Li H et al. Cancer statistics in China and United States, 2022: profiles, trends, and determinants. Chin Med J (Engl) 2022; 135: 584-590.
2 Hu JX, Zhao CF, Chen WB et al. Pancreatic cancer: A review of epidemiology, trend, and risk factors. World J Gastroenterol 2021; 27: 4298-4321.
About Tumor Treating Fields
Tumor Treating Fields (TTFields) comprise electric fields designed to exert physical forces to destroy cancer cells via varied means. TTFields work by not affecting healthy cells within the body substantially due to differences in their characteristics like their division rate, shape, and electrical properties as compared with malignant ones. These distinct, multitarget mechanisms work together to identify and eliminate cancer cells. Because of the multimechanistic actions, TTFields therapy may be a useful addition to accepted cancer treatments to boost their effect in various solid tumor types when used with chemotherapy, radiation therapy, immune checkpoint inhibition, or selected targeted therapies inside preclinical models. TTFields therapy demonstrates a wide range of applications which have the potential to confront treatment difficulties over a range of solid tumor types.
Discover more about TTFields therapy and its multifaceted impact on cancer cells by visiting tumortreatingfields.com.
About Zai Lab
Zai Lab is a research driven, biopharmaceutical business that’s based in China and the United States. Its focus is the discovery, development, and commercialization of groundbreaking products that address important medical needs within oncology, immunology, neuroscience and also infectious disease. Its goal is to harness its talents and resources to enhance global human health through cutting edge science.
For additional information about Zai Lab, please visit www.zailaboratory.com or follow us at www.X.com/ZaiLab_Global , www.twitter.com/ZaiLab_Global.
About Novocure
Novocure is a global oncology company concentrated on increasing the survival rates on some of the highly aggressive forms of cancer through the development and commercialization of its novel Tumor Treating Fields therapy. Novocure’s commercialized products hold approval in some countries for the treatment of adults with glioblastoma, non-small cell lung cancer, malignant pleural mesothelioma, and pleural mesothelioma. Novocure has several additional active or complete clinical studies, investigating the use of Tumor Treating Fields therapy in the treatment of many cancers, including glioblastoma, non-small cell lung cancer and pancreatic cancer.
Novocure has its global headquarters in Baar, Switzerland, with its U.S. headquarters in Portsmouth, New Hampshire and research and development facilities in Haifa, Israel. For further information, visit Novocure.com and follow @Novocure on LinkedIn and Twitter.
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