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December 19, 2017

BeiGene starts Phase II ovarian cancer trial in China

BeiGene has started dosing patients in a Phase II clinical trial of its investigational candidate pamiparib (BGB-290) for the treatment of advanced ovarian cancer in China.

BeiGene has started dosing patients in a Phase II clinical trial of its investigational candidate pamiparib (BGB-290) for the treatment of advanced ovarian cancer in China.

Pamiparib is a PARP inhibitor designed to target PARP1 and PARP2. It is being developed both as a monotherapy and combination therapy for different solid tumour malignancies.

The single-arm, open-label, multi-centre Phase II trial will assess the safety, efficacy, tolerability and pharmacokinetics of pamiparib in 100 subjects suffering from fallopian cancer or primary peritoneal cancer with a known or suspected deleterious germline BRCA1/2 mutation.

Patients who have previously undergone a minimum of two lines of therapy in the advanced or metastatic setting will be recruited for the study.

“Patients in China have limited treatment options, especially following platinum-based therapy.”

BeiGene founder and CEO John Oyler said: “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.”

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The primary endpoint of the trial is objective response rate (ORR) measured using Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST V1.1).

In addition, the trial includes secondary endpoints such as progression-free survival, ORR as evaluated by investigators, duration of response, safety, disease control rate, tolerability, and pharmacokinetic profile.

BeiGene Immuno-Oncology chief medical officer Amy Peterson said: “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.”

 

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