Novocure posts positive mesothelioma data; to file for FDA exemption
Novocure (NASDAQ:NVCR) reported positive top-line results from its STELLAR Phase 2 pilot trial in mesothelioma.
The data demonstrate clinically meaningful improvements in overall survival and progression free survival among patients who received Tumor Treating Fields plus standard-of-care chemotherapy, compared with historical control data of patients who received standard-of-care chemotherapy alone.
The final data exceeded results of the interim analysis presented in December 2016. No device-related serious adverse events were reported.
In a statement, Dr. Eilon Kirson, CSO and head of R&D, said the STELLAR data reinforce the company’s belief that Tumor Treating Fields may be a broadly applicable platform technology for the treatment of solid tumors.
Novocure previously received humanitarian use device designation for the use of Tumor Treating Fields for the treatment of pleural mesothelioma.
Based on the final STELLAR data, Novocure plans to submit a humanitarian device exemption (HDE) application for FDA approval. An approved HDE would allow Novocure to market Tumor Treating Fields in combination with standard-of-care chemotherapy as a treatment for pleural mesothelioma in the U.S.