Novocure (NSDQ:NVCR) today touted positive top-line data from its Phase II pilot mesothelioma trial and revealed that it plans to submit a humanitarian device exemption application to the FDA for approval.
The St. Helier, N.J.-based company reported that patients who received treatment with its “Tumor Treating Fields” system plus chemotherapy experienced clinically meaningful improvements in overall survival and progression-free survival compared to historical control data.
Novocure’s device delivers low-intensity, intermediate frequency, alternating electric fields, called “Tumor Treating Fields,” to inhibit cancer cell replication.
The company’s Phase II single-arm pilot trial enrolled 80 patients with unresectable, previously untreated malignant pleural mesothelioma. The historical control for the study included the results of a 2003 Phase III FDA registration trial.
“We are extremely pleased with these top-line results, which bring us one step closer to realizing the potential for a new treatment for mesothelioma patients in desperate need,” Dr. Eilon Kirson, chief science officer and head of R&D, said in prepared remarks.
“Mesothelioma is the first torso indication for which Novocure will pursue FDA approval. The Stellar data reinforce our belief that Tumor Treating Fields may be a broadly applicable platform technology for the treatment of solid tumors. We look forward to sharing the detailed results of the study with the lung cancer community at an upcoming medical conference,” Kirson added.
An interim analysis reported in Dec. 2016 concluded that the one-year survival rate of patients treated with Novocure’s device and chemotherapy was 80% compared to 50% in historical controls. Median progression-free survival in the device group was 7.3 months versus 5.7 months in the control group, the company reported.