Novocure Enrolls Last Patient in PANOVA Trial of Tumor Treating Fields Plus Chemotherapy in Advanced Pancreatic Cancer
Novocure (NASDAQ: NVCR) announced today that the last patient has been enrolled in the PANOVA trial, a phase 2 pilot trial testing Tumor Treating Fields (TTFields) plus chemotherapy in 40 patients with advanced pancreatic cancer. The final data collection date will be six months after the last patient in.
"The first cohort of the PANOVA trial demonstrated the safety and feasibility of combining TTFields with gemcitabine in pancreatic cancer," said Dr. Marc Kueng, Senior Internist and Medical Oncologist at the Cantonal Hospital of Fribourg in Switzerland. "The combination with nab-paclitaxel has a strong scientific rationale and is compliant with the current standard of care. We are looking forward to opening a randomized-controlled study testing the efficacy of TTFields in this difficult disease."
The prospective, single-arm study includes two cohorts of 20 patients with advanced pancreatic cancer whose tumors could not be removed surgically and who had not received prior chemotherapy or radiation therapy. Novocure presented data from the first cohort of the trial at the American Society of Clinical Oncology 2016 Gastrointestinal Cancers Symposium in January 2016.
Data from the first cohort demonstrated the safety of the combined treatment, and also suggest improved survival and response rate among patients who received TTFields therapy with gemcitabine compared to a historical control of patients who received gemcitabine alone. PANOVA patients who received TTFields therapy plus first-line gemcitabine experienced a median progression free survival of 8.3 months compared to 3.7 months for a historical control of gemcitabine alone, and a median overall survival of 14.9 months compared to 6.7 months for a historical control. Median one-year survival was 55 percent compared to 22 percent for a historical control. Of the 19 of 20 evaluable tumors, 30 percent had partial responses compared to 7 percent with gemcitabine alone and another 30 percent had stable disease. Novocure accelerated planning for a phase 3 clinical trial in pancreatic cancer after obtaining results for the first cohort of PANOVA.
The PANOVA trial was expanded in January 2015 to include a second cohort of 20 patients testing TTFields plus gemcitabine and nab-paclitaxel. Preclinical models have demonstrated increased cancer cell sensitivity when TTFields therapy is combined with taxane-based chemotherapies, such as nab-paclitaxel.
"Our preclinical research of TTFields therapy combined with taxane-based chemotherapies demonstrated a synergistic effect," said Dr. Eilon Kirson, Chief Science Officer and Head of Research and Development at Novocure. "Given that synergy, we are optimistic about what the second cohort will show when nab-paclitaxel is added to the treatment regimen and look forward to sharing the results."
About Pancreatic Cancer
Pancreatic cancer is the fourth leading cause of cancer death in the U.S. The National Cancer Institute estimated that about 48,960 people would be diagnosed with pancreatic cancer and about 40,560 people would die from the disease in 2015. Five-year survival among pancreatic cancer patients is less than 6 percent. Tumor Treating Fields (TTFields) therapy is not approved for the treatment of pancreatic cancer by the U.S. Food and Drug Administration. The safety and effectiveness of TTFields therapy for pancreatic cancer has not been established.
Novocure is a commercial-stage oncology company developing a novel, proprietary therapy called Tumor Treating Fields, or TTFields, for the treatment of solid tumor cancers. Headquartered in Jersey, Novocure has U.S. operations in Portsmouth, New Hampshire, Malvern, Pennsylvania, and New York City. Additionally, the company has offices in Germany, Switzerland and Japan, and a research center in Haifa, Israel. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure.
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