Novocure™ (NASDAQ: NVCR) announced today that the first patient has been enrolled in the RTOG Foundation’s phase 2 pilot trial testing Optune together with bevacizumab for patients with bevacizumab-refractory recurrent glioblastoma (GBM).
Optune is an FDA-approved Tumor Treating Fields (TTFields) delivery system for the treatment of newly diagnosed and recurrent GBM. In recurrent GBM, both Optune and bevacizumab are approved as monotherapies. The current trial intends to test the efficacy and safety of Optune in combination with bevacizumab for the treatment of patients with bevacizumab-refractory recurrent GBM.
Dr. Manmeet Ahluwalia, Dean and Diane Miller Endowed Chair in NeuroOncology at Cleveland Clinic and Co-Principal Investigator of the trial said, The results of this trial will provide additional information to the brain tumor research community on the safety and effectiveness of using Optune in combination with bevacizumab in patients with bevacizumab-refractory recurrent GBM. He added, “These patients face a dismal prognosis and are in need of treatment options.”
The RTOG Foundation Study RTOG 3503 is planned to include 85 patients at 20 institutions in the United States. Patients must have a recurrence or progression of GBM or other grade IV glioma after being treated with bevacizumab. The trial will determine the efficacy of Optune together with bevacizumab measured by overall survival at six months. Additional endpoints include overall and progression-free survival from time of registration, response rates, and toxicities of bevacizumab with Optune.
Dr. Eilon Kirson, Chief Science Officer and Head of Research and Development at Novocure notes, “This is the first consortium study of TTFields, demonstrating the continued and mounting interest in Optune from the scientific community.” “Our EF-11 phase 3 pivotal trial in recurrent GBM patients suggested that in a subgroup of patients who were refractory to bevacizumab Optune monotherapy led to an extension in survival versus chemotherapy. We are excited that RTOG is researching the potential benefit of Optune together with bevacizumab in this difficult-to-treat population of patients,” concluded Kirson.
“For 40 years, RTOG has conducted studies designed to improve the survival and quality of life of cancer patients,” said Dr. Jeffrey J. Raizer, Co-Founding-Director of the Northwestern Brain Tumor Institute and Co-Principal Investigator of the trial. “RTOG is excited to partner with Novocure on this important study, and I am pleased to be able to offer Optune to patients in this study.”
For more information on the trial designs, visit clinicaltrials.gov and reference NCT02743078. Treatment with TTFields is not approved in combination with bevacizumab for the treatment of patients with bevacizumab-refractory recurrent GBM by the U.S. Food and Drug Administration. The safety and effectiveness of TTFields in combination with bevacizumab for the treatment of patients with bevacizumab-refractory recurrent GBM has not been established.