Phase III pivotal INNOVATE-3 study of Optune + paclitaxel given approval to continue by IDMC in ovarian cancer.- Novocure
Novocure announced the results of a pre-specified interim analysis for the phase III pivotal INNOVATE-3 study evaluating the safety and efficacy of Tumor Treating Fields (TTFields) Optune + paclitaxel for the treatment of patients with platinum-resistant ovarian cancer.
An 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.
The 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.
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