Pancreatology Publishes Results of the PANOVA Phase 2 Pilot Trial in Advanced Pancreatic Cancer Suggesting Improved Survival of Patients Treated with Tumor Treating Fields
The Tumor Treating Fields plus gemcitabine and nab-paclitaxel patient cohort showed progression free and one-year survivals that were more than double those of the gemcitabine and nab-paclitaxel-treated historical control
ST. HELIER, Jersey–(BUSINESS WIRE)– Novocure (NASDAQ: NVCR) announced today that the results of its PANOVA phase 2 pilot trial have been published in Pancreatology. The PANOVA pilot trial was a prospective, single-arm study testing the feasibility, safety and preliminary efficacy of Tumor Treating Fields in patients with advanced pancreatic cancer whose tumors could not be removed surgically and who had not received chemotherapy or radiation therapy prior to entering the clinical trial. Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and causing affected cancer cells to die.
“Pancreatic cancer is one of the most aggressive forms of cancer, taking the lives of more than 432,000 people worldwide each year,” said Fernando Rivera, MD, PhD, the study’s principal investigator and a Senior Medical Oncologist at the Santander University Hospital M Valdecilla in Spain. “The results of the PANOVA pilot trial are promising and may provide hope to advanced pancreatic cancer patients who are in urgent need of treatment options that extend survival.”
The trial included 40 patients with advanced pancreatic cancer in two cohorts, 20 of whom received Tumor Treating Fields plus gemcitabine and 20 of whom received Tumor Treating Fields plus gemcitabine and nab-paclitaxel. The primary endpoint was safety. Secondary endpoints included progression free survival and overall survival.
In the Tumor Treating Fields plus gemcitabine cohort, progression free survival and overall survival were each more than double those of the gemcitabine-treated historical control¹. Advanced pancreatic cancer patients treated with Tumor Treating Fields plus gemcitabine experienced a median progression free survival of 8.3 months (95% CI 4.3, 10.3) and a median overall survival of 14.9 months (95% CI 6.2, NA), compared to 3.7 months and 6.7 months, respectively, in the gemcitabine historical control.
In the Tumor Treating Fields plus gemcitabine and nab-paclitaxel cohort, progression free survival and the one-year survival rate were more than double those of the gemcitabine and nab-paclitaxel-treated historical control¹. Advanced pancreatic cancer patients treated with Tumor Treating Fields plus gemcitabine and nab-paclitaxel experienced a median progression free survival of 12.7 months (95% CI 5.4, NA), compared to 5.5 months in the nab-paclitaxel plus gemcitabine historical control. Median overall survival for the Tumor Treating Fields and gemcitabine plus nab-paclitaxel cohort was not yet reached. The one-year survival rate of patients treated with Tumor Treating Fields plus gemcitabine and nab-paclitaxel was 72 percent, compared to 35 percent in a gemcitabine plus nab-paclitaxel historical control. Twenty-one patients reported skin toxicity related to Tumor Treating Fields. No serious adverse events related to Tumor Treating Fields were reported.
In December 2017, Novocure initiated its PANOVA-3 phase 3 pivotal clinical trial designed to determine the efficacy and safety of Tumor Treating Fields with nab-paclitaxel and gemcitabine as a front-line treatment for unresectable locally advanced pancreatic cancer.
About Pancreatic Cancer
Pancreatic cancer was the third leading cause of cancer death in the U.S. in 2018. Five-year survival among patients with pancreatic cancer is about 8 percent. The American Cancer Society estimated that about 55,440 people would be diagnosed with pancreatic cancer and about 44,330 people would die from the disease in 2018. Worldwide, more than 432,000 people die from the disease every year. The safety and effectiveness of TTFields therapy for pancreatic cancer has not been established.
Novocure is an oncology company developing a profoundly different cancer treatment utilizing a proprietary therapy called Tumor Treating Fields, the use of electric fields tuned to specific frequencies to disrupt solid tumor cancer cell division. Novocure’s commercialized product is approved for the treatment of adult patients with glioblastoma. Novocure has ongoing or completed clinical trials investigating Tumor Treating Fields in brain metastases, non-small cell lung cancer, pancreatic cancer, ovarian cancer, liver cancer and mesothelioma.
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, Japan and Israel. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure.
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, clinical trial progress, development of potential products, interpretation of clinical results, prospects for regulatory submission and approval, manufacturing development and capabilities, market prospects for its products, coverage, collections from third-party payers and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions as well as more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on February 22, 2018, with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.
1Increased Survival in Pancreatic Cancer with nab-Paclitaxel plus Gemcitabine, The New England Journal of Medicine, October 2013, DOI: 10.1056/NEJMoa1304369
Media and Investor Contact:
Ashley Cordova, 212-767-7558