Today, CTI Biopharma Corp. announced that an independent committee has recommended that the company continue its ovarian cancer study.
The company said that the Gynecologic Oncology Group, now part of NRG Oncology, informed CTI that an independent Data Monitoring Committee (DMC) recommended continuation of the Phase III GOG-0212 clinical study, evaluating Opaxio (paclitaxel poliglumex) as maintenance therapy in ovarian cancer. There were no recommended changes following a second of four planned interim analyses for survival and futility.
The late-stage study 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. CTI continues to be blinded to the interim analysis results for the GOG-0212 study, which is the largest maintenance study in this setting, with 1,150 patients enrolled.
The Phase III trial is evaluating 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. The study’s primary endpoint is overall survival (OS) of patients treated with Opaxio compared to no maintenance therapy, and secondary endpoints are progression-free survival, safety and quality of life.
“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, MD, 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.”
Ovarian cancer is the seventh most commonly diagnosed cancer in women and the leading cause of cancer-related death among women worldwide. Every year, over 238,000 women will be diagnosed with ovarian cancer around the world and approximately 152,000 will die from the disease. Treatment typically involves advanced surgery and chemotherapy.
Opaxio is an investigational, biologically enhanced chemotherapeutic that links paclitaxel to a biodegradable polyglutamate polymer, which results in a new chemical entity. When bound to the polymer, paclitaxel is inactive, potentially sparing normal tissue’s exposure to high levels of paclitaxel and its associated toxicities. Blood vessels in tumor tissue, unlike blood vessels in normal tissue, are porous to macromolecules such as Opaxio. Preclinical studies have shown that Opaxio is preferentially distributed to tumors due to their leaky blood vessels and trapped in the tumor bed, allowing significantly more of the dose of chemotherapy to localize in the tumor than with standard paclitaxel. Once inside the tumor cell, enzymes metabolize the protein polymer, releasing active paclitaxel.
Source: CTI BioPharma Corp