On February 3, 2015 CTI BioPharma reported that the Gynecologic Oncology Group, now part of NRG Oncology, informed CTI BioPharma that an independent Data Monitoring Committee (DMC) recommended continuation of the GOG-0212 Phase 3 clinical study of OPAXIO (paclitaxel poliglumex) as maintenance therapy in ovarian cancer with no changes following a second of four planned interim analyses for survival and futility (Press release CTI BioPharma, FEB 2, 2015, View Source;p=RssLanding&cat=news&id=2012846 [SID:1234501445]). CTI BioPharma remains blinded to the interim analysis results. GOG-0212 is the largest maintenance study in this setting, having enrolled 1,150 patients.

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The trial is being conducted and managed by the Gynecologic Oncology Group, now part of NRG Oncology, which is one of the National Cancer Institute’s funded cooperative cancer research groups with a focus on the study of gynecologic malignancies.

"We believe that there remains a significant unmet need in keeping a patient’s cancer from returning following initial treatment for ovarian cancer," said James A. Bianco, M.D., CTI BioPharma’s President and Chief Executive Officer. "The GOG-0212 study is designed to investigate whether Opaxio, when used in a maintenance setting in ovarian cancer, could keep these women in remission and potentially extend their lives."