On December 18, 2017 BeiGene, Ltd. (NASDAQ:BGNE), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly targeted and immuno-oncology drugs for the treatment of cancer, reported that the first patient was dosed in a pivotal Phase 2 clinical trial of pamiparib (BGB-290), an investigational PARP inhibitor, in Chinese patients with advanced ovarian cancer (Press release, BeiGene, DEC 18, 2017, View Source;p=RssLanding&cat=news&id=2323078 [SID1234522679]).
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"We are pleased to announce the initiation of the first pivotal trial of pamiparib in China. Clinical development began in Australia in July 2014 and in China in December 2016. Pamiparib is being evaluated in several global clinical trials in a broad range of indications, both as monotherapy and in combination with tislelizumab (BGB-A317), our anti-PD-1 antibody, with chemotherapy or with radiotherapy. We look forward to advancing pamiparib in China, where no PARP inhibitor has been approved," commented John V. Oyler, Founder, Chief Executive Officer, and Chairman of BeiGene.
"Patients with advanced ovarian cancer who harbor a germline BRCA mutation will be recruited to this study. Patients in China have limited treatment options, especially following platinum-based therapy, despite the multiple approvals of PARP inhibitors in other regions of the world," commented Amy Peterson, M.D., Chief Medical Officer for Immuno-Oncology of BeiGene.
The pivotal Phase 2 single-arm, open-label, multi-center trial is designed to evaluate the efficacy, safety, tolerability, and pharmacokinetic profile of pamiparib in patients with high-grade ovarian cancer, including fallopian cancer or primary peritoneal cancer, harboring a known or suspected deleterious germline BRCA1/2 mutation. This trial plans to enroll approximately 100 patients who have received at least two previous lines of therapy in the advanced or metastatic setting, and will be divided into two cohorts according to their platinum-sensitivity status. The trial’s primary endpoint is objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1), as assessed by independent radiology review. Secondary endpoints include ORR as assessed by investigators, progression-free survival, duration of response, overall survival, disease control rate, best overall response, clinical benefit rate, safety, tolerability, and pharmacokinetic profile. Professor Xiaohua Wu of the Fudan University Cancer Center is the lead principal investigator of the trial.
About Pamiparib
Pamiparib (BGB-290) is an investigational inhibitor of PARP1 and PARP2 which demonstrated pharmacological properties such as brain penetration and PARP–DNA complex trapping in preclinical models. Pamiparib is currently in global clinical development as a monotherapy and in combination with other agents for a variety of solid tumor malignancies.