Celgene has announced a new arm of a phase 1b study that will study Novocure’s noninvasive brain cancer therapy alongside the combination of temozolomide and marizomib, a cancer drug that is still in development.
The Optune device is FDA-approved for the treatment of glioblastoma, an aggressive brain cancer. It is used alone for patients with recurrent glioblastoma, but it is used in tandem with the chemotherapy drug temozolomide in patients with newly diagnosed glioblastoma. This trial is the first to investigate Optune in combination with an investigational drug.
Novocure recommends that patients wear Optune for at least 18 hours per day. The device delivers the company’s Tumor Treating Fields (TTFields) therapy via four adhesive patches. It scored the FDA nod for recurrent glioblastoma in 2011 and snagged approval as a first-line treatment in 2015. Last year, the FDA approved its smaller, lighter follow-up.
The new trial will study the safety of using temozolomide, marizomib and Optune to treat patients with newly diagnosed glioblastoma who have already undergone radiation therapy and temozolomide. Celgene has modified its ongoing combo therapy trial to include Optune.
“This collaboration marks an important first step toward testing Optune with a promising new investigational compound for the treatment of GBM [glioblastoma],” said principal investigator Roger Stupp, M.D., associate director for strategic initiatives at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. “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 1b study, will help advance our understanding of how to treat this devastating disease.”
Beyond glioblastoma, Novocure is testing its TTFields treatment in pancreatic and ovarian cancers. In January 2016, the company reported phase 2 data showing the TTFields tech improved survival and response rate in patients with inoperable pancreatic tumors who had not received chemotherapy or radiation therapy. And in December, phase 2 pilot data showed the treatment was safe and effective when administered with paclitaxel to patients with recurrent ovarian cancer.