Novocure Announces the Completion of Enrollment of its PANOVA Trial of Tumor Treating Fields Plus Gemcitabine for Treatment of Pancreatic Cancer
The PANOVA trial will now be expanded to treat an additional twenty advanced pancreatic cancer patients with concomitant TTFields, gemcitabine and nab-paclitaxel
ST. HELIER, Jersey–(BUSINESS WIRE)–Novocure, a commercial stage oncology company, announced today that the last patient has been enrolled in the PANOVA trial, an open-label phase II clinical trial of Tumor Treating Fields (TTFields) together with gemcitabine in twenty patients with newly-diagnosed advanced pancreatic adenocarcinoma. In light of the rapid conclusion of enrollment, the absence of serious safety concerns, to date, and following a request by study physicians, Novocure will expand the trial to include an additional study cohort of twenty patients who will be treated with concomitant TTFields, gemcitabine and nab-paclitaxel.
“PANOVA is the first clinical study testing TTFields in pancreatic cancer,” said Uri Weinberg, MD, PhD, Vice President, Research and Development of Novocure. “We thank the first twenty patients and their physicians for participating in the trial. Since the safety profile, to date, on this protocol has been in line with previous clinical experience in other indications, we plan to test the combination of TTFields with gemcitabine and nab-paclitaxel in an additional cohort of patients. We hope to see the same synergistic effect that was demonstrated in preclinical models when TTFields therapy was combined with taxane-based chemotherapy.”
“We are proud to take part in a clinical trial testing a novel approach for the treatment of pancreatic cancer,” said Fernando Rivera, MD, Senior Medical Oncologist at the Santander University Hospital in Spain, who has treated five patients under the PANOVA protocol. “This regional, non-invasive treatment that acts on dividing cancer cells has the potential to make a real change in the treatment paradigm for many of the 340,000 patients diagnosed with pancreatic cancer worldwide every year, mostly at an advanced, non-curable stage. As the first cohort demonstrated that TTFields is well-tolerated by patients, we should now investigate TTFields in combination with gemcitabine and nab-paclitaxel, which is a new standard therapy in advanced pancreatic cancer.”
“Novocure is committed to studying TTFields in solid tumor cancers,” said Asaf Danziger, Chief Executive Officer of Novocure. “Novocure is currently running clinical trials testing the safety and efficacy of TTFields in pancreatic cancer, glioblastoma, brain metastasis from lung cancer and ovarian cancer. Additional clinical trials testing TTFields alone or together with standard of care chemotherapy will be initiated during 2015.”
About the PANOVA Trial
PANOVA is an open-label phase II clinical trial designed to test the safety and preliminary efficacy of TTFields therapy together with gemcitabine for the first line treatment of pancreatic adenocarcinoma. Following regulatory approval, PANOVA will enroll an additional cohort of twenty patients in Spain, Germany and Switzerland investigating TTFields in combination with gemcitabine and nab-paclitaxel. For more information please refer to www.clinicaltrials.gov.
About Pancreatic Cancer
Pancreatic cancer is the fourth leading cause of cancer-related death in the United States and Europe. Prognosis is poor, with a five-year overall survival rate of 5% for all cases, as close to 85% of patients will be diagnosed with advanced, non-resectable disease. Recently, albumin-bound pactlitaxel (nab-paclitaxel) combined with gemcitabine has demonstrated a statistically significant survival benefit compared to gemcitabine alone, making it a new treatment option for advanced pancreatic cancer.
About Tumor Treating Fields Therapy
Tumor Treating Fields (TTFields) therapy is delivered by a portable, non-invasive medical device designed for continuous use by patients. In vitro and in vivo studies have shown that TTFields therapy slows and reverses tumor growth by inhibiting mitosis, the process by which cells divide and replicate. TTFields therapy creates a low intensity, alternating electric fields within a tumor that exerts physical forces on electrically charged cellular components, preventing the normal mitotic process and causing cancer cell death.
Novocure is a private Jersey Isle oncology company pioneering a novel therapy for solid tumors called TTFields. Novocure’s US operations are based in Portsmouth, NH and New York, NY. Additionally, the company has offices in Switzerland and Japan and a research center in Haifa, Israel. For additional information about the company, please visit www.novocure.com.
Ashley Cordova, 212-767-7558