BeiGene has enrolled the first patient in a Phase III clinical trial evaluating pamiparib (BGB-290), an investigational PARP inhibitor, as a potential maintenance therapy to treat patients with platinum-sensitive recurrent ovarian cancer.
The placebo-controlled, multi-centre trial intends to enrol around 215 patients at 15-20 cancer centres in China.
The trial aims to examine the efficacy of maintenance therapy with pamiparib against a placebo in patients with recurrent ovarian cancer who achieved a complete response or partial response after platinum-based chemotherapy, as measured by progression-free survival (PFS) determined by independent review.
Its secondary endpoints include PFS per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 determined by investigator, as well as overall survival, objective response rate, duration of response, time to response, safety, and tolerability.
Huazhong University of Science and Technology Tongji Medical College Obstetrics and Gynecology director Ding Ma is the principal investigator of the trial.
BeiGeneChina Developmentsenior vice-president and head Lai Wang said: “In China there are currently no approved PARP inhibitors, despite the multiple approvals of PARP inhibitors in other regions of the world and in a variety of settings.
“Our development programme in ovarian cancer is designed to address the limited treatment options that currently exist for these patients in China.”
In China, more than 50,000 women are estimated to be diagnosed with ovarian cancer and more than 22,000 die from the disease annually. More than 70% of patients are reportedly diagnosed with advanced disease in China.