Mar 31 2017
Novocure (NASDAQ: NVCR) announced today results from the second cohort of its phase 2 pilot PANOVA trial studying Tumor Treating Fields (TTFields) in combination with nab-paclitaxel and gemcitabine for the treatment of advanced pancreatic cancer. These results will be presented (Abstract CT130) on Tuesday, April 4 at the American Association for Cancer Research Annual Meeting 2017 in Washington, D.C.
The PANOVA trial was a prospective, single-arm study testing the feasibility, safety and preliminary efficacy of Tumor Treating Fields (TTFields) in patients with advanced pancreatic cancer whose tumors could not be removed surgically and who had not received chemotherapy or radiation therapy prior to the clinical trial. The second cohort included 20 patients who received a combination treatment regimen of TTFields plus nab-paclitaxel and gemcitabine.
Median progression free survival in the TTFields-treated group was 12.7 months (compared to 5.5 months in nab-paclitaxel plus gemcitabine historical controls) and median overall survival was not yet reached. The median overall survival was not reached and the one-year survival rate was 72 percent (compared to 35 percent in nab-paclitaxel plus gemcitabine historical controls). Forty percent of the evaluable tumors had partial responses (compared to 23 percent with nab-paclitaxel plus gemcitabine alone) and another 47 percent had stable disease (compared to 27 percent with nab-paclitaxel plus gemcitabine alone). Patients reported no serious adverse events related to TTFields.
"Pancreatic cancer kills more than 300,000 individuals each year worldwide. As the vast majority of pancreatic cancer cases are diagnosed during the late stages, patients with advanced disease are in dire need of additional treatment options," said Dr. Manuel Benavides, Chief Medical Oncologist at the Hospital Universitario Regional y Virgen de la Victoria in Málaga, Spain. "The phase 2 pilot results look promising, and I look forward to further study of TTFields in pancreatic cancer."
Novocure is in the final stages of protocol development for a phase 3 pivotal trial studying TTFields in combination with nab-paclitaxel and gemcitabine as a first-line treatment for locally advanced, nonresectable, pancreatic cancer. The company anticipates it will enroll the first patient in the second half of 2017 with data available for presentation approximately 18 months following last patient enrollment.
"We are extremely pleased with these results," said Dr. Eilon Kirson, Novocure's Chief Science Officer and Head of Research and Development. "These data give us hope that TTFields used in combination with other cancer treatments may increase survival without significantly increasing side effects for a variety of solid tumors."
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.