Novocure speeds up trial of drug-device combo in pancreatic cancer

Novocure has teamed up with a cancer physician network to accelerate patient recruitment in its pivotal pancreatic cancer trial, which pairs a tumor-killing device with chemotherapy.

US Oncology Research has agreed to open 10 clinical trial sites for the PANOVA-3 trial, which is due to read out in 2022, according to the New Jersey biotech. The network’s chief scientific officer Daniel D. Von Hoff, M.D., F.A.C.P., will act as the principal investigator in the study.

PANOVA-3 is testing Novocure’s Tumor-Treating Fields wearable device to see if it can improve the efficacy of nab-paclitaxel and gemcitabine—a widely-used chemotherapy regimen for advanced pancreatic cancer patients—without adding to toxicity. The battery-powered unit delivers alternating electrical fields to the vicinity of the tumor via electrodes placed on the skin and is designed to disrupt cell division, inhibiting tumor growth and causing affected cancer cells to die.

The technology is already being used commercially in Novocure’s Optune product for brain cancer glioblastoma multiforme (GBM), which was approved in its first iteration by the FDA in 2011 and has grown into a $200 million-plus product, thanks in part to an improved version which got a green light in 2016.

Last year, Novocure reported positive data from the phase 2 PANOVA trial of the drug-device combination in 20 patients whose tumors could not be surgically removed and who had not undergone chemotherapy or radiation therapy. The results showed median progression-free survival of 12.7 months for Novocure’s therapy, which compared to 5.5 months among historical controls treated with the drugs only.

"Pancreatic cancer is one of the most aggressive forms of cancer and was the third leading cause of cancer death in the U.S. last year," said Dr. Von Hoff. "I believe Tumor-Treating Fields has the potential to improve survival in this disease."

PANOVA-3 will enroll 556 patients with locally-advanced pancreatic cancer that can’t be treated with surgery, who will wear the Tumor-Treating Fields delivery system for at least 18 hours a day until the disease progresses. The primary outcome measure is overall survival, and the study will also look at PFS, response rates and quality-of-life.

Novocure is also developing the technology for use in brain metastases in the METIS trial, with final data collection due in 2020, and in non-small cell lung cancer via the LUNAR trial, which is due to read out a year later. Additional studies in ovarian cancer, mesothelioma and liver cancer are also on the go.

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