In recurrent GBM, Optune and bevacizumab are approved as monotherapies. Novocure’s consortium study is slated to evaluate the efficacy and safety of the Optune-chemo combo in patients with bevacizumab-refractory recurrent GBM.
The FDA-approved Optune mobile device delivers “tumor treating fields” – low-intensity, intermediate frequency, alternating electric fields – to inhibit cancer cell replication.
“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,” co-principal investigator Dr. Manmeet Ahluwalia said in prepared remarks. “These patients face a dismal prognosis and are in need of treatment options.”
The trial, which Novocure is conducting with the RTOG Foundation, is planned to enroll 85 patients. To assess the efficacy of Optune in combination chemotherapy, researchers plan to measure overall survival at 6 months. The company said it will also measure overall and progression-free survival from time of registration, response rates and toxicities.
“This is the 1st consortium study of TTFields, demonstrating the continued and mounting interest in Optune from the scientific community,” chief science officer & head of R&D Dr. Eilon Kirson said. “Our EF-11 Phase III 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.”
“For 40 years, RTOG has conducted studies designed to improve the survival and quality of life of cancer patients,” co-principal investigator Dr. Jeffrey Raizer added. “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.”