A phase 3 pivotal trial – PANOVA-3 – will test the efficacy of TTFields with gemcitabine and nab-paclitaxel as a front-line treatment of locally advanced pancreatic cancer
ST. HELIER, Jersey–(BUSINESS WIRE)– Novocure (NASDAQ: NVCR) announced today that the company will present three abstracts studying Tumor Treating Fields (TTFields) in pancreatic cancer at the European Society for Medical Oncology 19th World Congress on Gastrointestinal Cancer on June 28 through July 1 in Barcelona. Among the highlights is an abstract that will outline the trial design for PANOVA-3, Novocure’s phase 3 pivotal study of TTFields with gemcitabine and nab-paclitaxel as a front-line treatment of locally advanced pancreatic cancer.
PANOVA-3, a prospective, randomized trial, will include 600 patients with unresectable locally advanced pancreatic cancer. Patients should have an Eastern Cooperative Oncology Group (ECOG) score of 0-2 and no prior progression or treatment. Experimental-arm patients will use a TTFields delivery system tuned to 150 kHZ for at least 18 hours a day until the disease progresses. Follow up, including a CT scan of the chest and abdomen, will be performed every eight weeks. Patients who progress will be followed monthly for survival. The primary endpoint is overall survival. The secondary endpoints are progression-free survival, objective response rate, rate of resectability, quality of life and toxicity.
“We are excited to present our trial design for PANOVA-3. We accelerated the trial design after learning the results for our phase 2 pilot study of TTFields plus nab-paclitaxel and gemcitabine in patients with advanced pancreatic cancer, which more than doubled progression free survival and the one-year survival rate versus nab-paclitaxel and gemcitabine-treated historical controls,” said Dr. Eilon Kirson, Novocure’s Chief Science Officer and Head of Research and Development. “Pancreatic cancer kills more than 300,000 individuals each year worldwide. We are hopeful that TTFields combined with standard of care chemotherapy could potentially reduce metastasis and tumor size in these patients, making more patients candidates for resection. We hope to deliver better patient outcomes and address this unmet need.”
The following abstracts will be presented at the European Society for Medical Oncology 19th World Congress on Gastrointestinal Cancer:
PANOVA-2: A phase 2 study of TTFields (150 kHz) concomitant with standard chemotherapy for front-line therapy of advanced pancreatic adenocarcinoma – Updated efficacy results; M. Benavides, C. Guillen, F. Rivera, J. Gallego, J.A. Lopez-Martin, M. Küng; Thursday, June 29; abstract: #315
PANOVA-3: A phase 3 study of TTFields with gemcitabine and nab-paclitaxel for front-line treatment of locally-advanced pancreatic adenocarcinoma (LAPC); Uri Weinberg, Ori Farber, Moshe Giladi, Ze’ev Bomzon, Eilon Kirson; Thursday, June 29; abstract: P-230
A simulation-based study on the distribution of TTFields in the body when treating pancreatic cancer; Cornelia Wenger, Ofir Yesharim, Ariel Naveh, Hadas Hershkovich, Uri Weinberg and Ze’ev Bomzon; Thursday, June 29; abstract: #335
TTFields are 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.
About Pancreatic Cancer
Pancreatic cancer is the fourth leading cause of cancer death in the U.S. The American Cancer Society estimated that about 53,000 people would be diagnosed with pancreatic cancer and about 42,000 people would die from the disease in 2016. Worldwide, more than 330,000 people die from the disease every year. Five-year survival among patients with metastatic pancreatic cancer is 2 percent.
Novocure is an oncology company developing a profoundly different cancer treatment utilizing a proprietary therapy called TTFields, the use of electric fields tuned to specific frequencies to disrupt solid tumor cancer cell division. Novocure’s commercialized product, Optune, is approved for the treatment of adult patients with glioblastoma. Novocure has ongoing or completed clinical trials investigating TTFields in brain metastases, non-small cell lung cancer, pancreatic cancer, ovarian 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 and Japan, and Israel. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure.
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