CTI BioPharma: Independent DMC Urges Continuing GOG-0212 Phase 3 Trial Of OPAXIO

(RTTNews) - CTI BioPharma Corp. (CTIC) said the Gynecologic Oncology Group, now part of NRG Oncology, informed CTI BioPharma that an independent Data Monitoring Committee or DMC recommended continuation of the GOG-0212 Phase 3 study of OPAXIO as maintenance therapy in ovarian cancer with no changes following a second of four planned interim analyses for survival and futility. CTI BioPharma remains blinded to the interim analysis results. GOG-0212 is the largest maintenance study in this setting, enrolling 1,150 patients.

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 Bianco, M.D., CTI BioPharma's President and Chief Executive. He added, "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."

The GOG-0212 study is a randomized, multicenter, open label Phase 3 study of either monthly Opaxio or paclitaxel for up to 12 consecutive months compared to surveillance among women with advanced ovarian cancer who have no evidence of disease following first-line platinum-taxane based therapy.