|The Optune system--Courtesy of Novocure|
Novocure ($NVCR) announced that it will present data on Friday at a meeting of the American Society of Clinical Oncology showing that its Tumor Treating Fields therapy and first-line chemotherapy is tolerable and safe in advanced pancreatic cancer, as it seeks to earn FDA approval for the use of its noninvasive cancer-fighting device to treat other types of cancer besides glioblastoma.
The Phase II data comes from an ongoing single-arm trial of 20 patients with advanced pancreatic cancer whose tumors could not be removed surgically, and who not had not received chemotherapy or radiation therapy, Novocure said in a release.
The company's TTFields therapy resulted in no serious adverse events and 10 cases of treatable contact dermatitis, according to the release. And the company save there is evidence that the addition of TTFields therapy results in an improved survival and response rate.
Comparing the trial data to a 2013 study in the New England Journal of Medicine, Novocure said TTFields plus chemotherapy (gemcitabine) achieved a median progression free survival of 8.3 months (compared to 3.7 months for chemotherapy alone), a median overall survival of 14.9 months (compared to 6.7 months), and a median one-year survival of 55% (compared to 22%).
"The phase 2 results are promising," said Dr. Fernando Rivera, the study's principal investigator and a senior medical oncologist at the Santander University Hospital in Spain, in a statement. "Given these first cohort results and the synergistic effect that was demonstrated in preclinical models when TTFields therapy was combined with taxane-based chemotherapies, I am even more optimistic about what the second cohort will show when nab-paclitaxel is added to the treatment regimen."
TTFields therapy is FDA-approved for treating recurrent glioblastoma and newly diagnosed glioblastoma, most common form of brain cancer. Besides pancreatic cancer, it is also in Phase II trials to treat brain metastasis, non-small cell lung cancer, ovarian cancer and mesothelioma.
Novocure says TTField disrupts the cell division process known as mitosis. The low-intensity, alternating electric fields are generated by the company's Optune system using a pair of transducer arrays placed on the skin surface in the region surrounding the tumor.
Novocure, which heads its U.S. operations from Portsmouth, NH, recently submitted a PMA supplement with the FDA in hopes of marketing an upgraded version of the Optune, which weighs about 3 pounds, half the weight of the first-generation device. And in October it won an expanded indication to treat diagnosed glioblastoma in combination with temozolomide, a standard chemotherapy.
- read the release