The FDA has given Novocure (NSDQ:NVCR) the green light to bring the company’s Tumor Treating Fields tech into a pivotal Phase III pancreatic cancer trial.
The 556-patient study is designed to assess the safety and efficacy of Novocure’s TTFields combined with nab-paclitaxel and gemcitabine as a front-line treatment for unresectable locally-advanced pancreatic cancer.
Panova III’s primary endpoint is overall survival, with secondary endpoints that include progression-free survival, local progression-free survival and objective response rate.
“Despite extensive clinical research, pancreatic cancer is the third leading cause of cancer death in the U.S. in 2017,” principal investigator Dr. Daniel Von Hoff said in prepared remarks. “Nearly all patients with pancreatic cancer are diagnosed when the tumors are no longer resectable. We must continue evaluating potential new treatments until we improve survival outcomes for patients with pancreatic cancer.”
Patients randomized to the experimental arm will use a TTFields delivery system tuned to 150 kHz for at least 18 hours a day until the disease progresses, according to St. Helier, N.J.-based Novocure.
In a Phase II trial of TTFields combined with nab-paclitaxel and gemcitabine, progression-free survival more than doubled in patients with advanced pancreatic cancer.
“Panova III is Novocure’s third Phase III pivotal trial beyond glioblastoma, demonstrating our commitment to developing TTFields as a treatment for a variety of solid tumors,” Dr. Eilon Kirson, chief science officer & head of R&D, added. “With the FDA IDE approval in hand, we are now working closely with trial sites and institutional review boards to open sites and enroll patients as quickly as possible.”
Novocure’s system delivers low-intensity, intermediate frequency, alternating electric fields, called ‘Tumor Treating Fields,’ to inhibit cancer cell replication.
