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Novocure Announces Favorable Recommendation to Continue the Phase 3 Pivotal INNOVATE-3 Study of Tumor Treating Fields in Ovarian Cancer
Pre-specified interim analysis concluded that the INNOVATE-3 study should proceed to final analysis as planned ST. HELIER, Jersey--(BUSINESS WIRE)-- Novocure
About this update from Novocure Limited
[{"type":"text","content":"\nPre-specified interim analysis concluded that the INNOVATE-3 study should proceed to final analysis as planned\n\n ST. HELIER, Jersey--(BUSINESS WIRE)--\nNovocure (NASDAQ: NVCR) today announced the results of a pre-specified interim analysis for the phase 3 pivotal INNOVATE-3 study evaluating the safety and efficacy of Tumor Treating Fields (TTFields) together with paclitaxel for the treatment of patients with platinum-resistant ovarian cancer.\n\nAn independent data monitoring committee (DMC) reviewed the safety data for all platinum-resistant ovarian cancer patients enrolled on the trial. In addition, an analysis of overall survival was performed on the first 540 patients randomized. The interim analysis did not indicate a need to increase the sample size and the DMC recommended that the study should continue to final analysis as planned.\n\n“Completion of the DMC interim analysis represents the next milestone in our journey to address the significant unmet need for patients diagnosed with platinum-resistant ovarian cancer,” said Dr. Ely Benaim, Novocure’s Chief Medical Officer. “I would like to thank our investigators and collaborators, ENGOT and The GOG Foundation, as well as our patients for their passion and bravery. We look forward to reviewing final data next year.”\n\nThe INNOVATE-3 study is designed to evaluate the safety and effectiveness of TTFields together with paclitaxel in patients with platinum-resistant ovarian cancer. There remains a significant unmet need for treatments for platinum-resistant ovarian cancer, for which approximately 16,000 patients are diagnosed each year in the U.S. The primary endpoint of INNOVATE-3 is overall survival. Secondary endpoints include progression-free survival, objective response rate, severity and frequency of adverse events, time to undisputable deterioration in health-related quality of life or death, and quality of life. The study accrued 540 patients as of October 2021 and data will be reviewed in 2023, following an 18 month follow-up period.\n\nThe European Network for Gynaecological Oncological Trial groups (\"ENGOT\") and The GOG Foundation, Inc. (\"GOG\"), third-party clinical trial networks, are collaborating with Novocure on the trial. Both ENGOT and GOG were involved in the development and facilitation of the trial at leading cancer centers in Europe and the United...