Novocure (NSDQ:NVCR) said today that it joined a Phase Ib study to evaluate the safety of Celgene‘s (NSDQ:CELG) marizomib and temozolomide in combination with Optune for patients with newly-diagnosed glioblastoma.
The trial is the first to assess Optune, the company’s “Tumor Treating Fields” delivery device, in combination with an investigational drug.
Celgene and Triphase changed their ongoing Phase Ib study of marizomib in combination with temozolomide and radiotherapy to include Optune. A group of 12 gliobastoma patients will be treated with the combination therapy following initial treatment with radiation and temozolomide, according to St. Helier, N.J.-based Novocure.
The primary endpoint for the study’s Optune branch is to evaluate the safety of the combination treatment with the addition of Optune. Secondary endpoints include preliminary clinical activity of the combo, Novocure said, including progression-free survival and overall survival.
The Optune arm is slated to open in the third quarter of this year.
The FDA-approved Optune device delivers low-intensity, intermediate frequency, alternating electric fields to inhibit cancer cell replication.
“This collaboration marks an important first step toward testing Optune with a promising new investigational compound for the treatment of GBM,” principal investigator Dr. Roger Stupp, associate director for strategic initiatives at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, said in prepared remarks. “Optune is the first treatment in over a decade to improve survival in GBM. I believe that combining Optune with new pharmacologic treatments in clinical trials, like this Phase Ib study, will help advance our understanding of how to treat this devastating disease.”
“We believe TTFields has the potential to be an excellent development candidate in combination with other solid tumor cancer treatments,” chief science officer & head of R&D, Eilon Kirson, added. “As innovators in cancer treatment, we know collaboration is essential to improve patient outcomes. We hope this is the first collaboration of many.”