On July 27, 2020 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company, reported that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has granted priority review status to the New Drug Application (NDA) of pamiparib, BeiGene’s investigational inhibitor of PARP1 and PARP2, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy (Press release, BeiGene, JUL 27, 2020, View Source [SID1234562409]).

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"Pamiparib is our third internally developed drug candidate that has been granted priority review in China, following tislelizumab and BRUKINSA. It received priority review within a week of the acceptance of the application, reflecting the unmet need for patients with this advanced disease," commented Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene. "We look forward to presenting the clinical data that support this NDA at an upcoming medical conference and the next milestones in the pamiparib program."

The NDA of pamiparib as a potential treatment for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer was accepted in July 2020. It is supported by clinical results from the pivotal Phase 2 portion of the Phase 1/2 trial (NCT03333915), which enrolled 113 patients in China with high-grade epithelial ovarian cancer (including fallopian tube or primary peritoneal cancer) or high-grade endometrioid epithelial cancer, harboring germline BRCA1/2 mutation, following at least two prior lines of standard chemotherapy. BeiGene is developing pamiparib as a monotherapy and in combination with other therapies for the treatment of a broad array of solid tumors.

Priority review and approval was established in China to facilitate drug registration management and accelerate the development of innovative drugs with significant clinical advantages and for which there is an urgent clinical need. According to the Drug Registration Regulation (Bureau Order 27) implemented on July 1, 2020, the regulatory authority will prioritize the review process and evaluation resources for applications under priority review. These applications are expected to have reduced review and approval timelines.

About Ovarian Cancer

In China, ovarian cancer is the tenth most common form of cancer among women, with over 50,000 new cases and more than 30,000 deaths in 2018.1 More than 60 percent of patients are diagnosed with advanced disease.2 The standard therapy for ovarian cancer consists of surgery followed by postoperative platinum-based chemotherapy. An estimated 70 percent of patients with epithelial ovarian cancer, which accounts for more than 90 percent of all ovarian cancer,3 who achieve a full remission following first-line therapy will develop recurrent disease.4

About Pamiparib

Pamiparib (BGB-290) is an investigational inhibitor of PARP1 and PARP2 which has demonstrated pharmacological properties such as brain penetration and PARP-DNA complex trapping in preclinical models. Discovered by BeiGene scientists, pamiparib is currently in global clinical development as a monotherapy or in combination with other agents for a variety of solid tumor malignancies. To date, more than 1,200 patients have been enrolled in clinical trials of pamiparib.

A New Drug Applications (NDA) for pamiparib for patients with ovarian cancer has been accepted and granted priority review by the Center for Drug Evaluation (CDE) of the NMPA.

About the Pamiparib Clinical Program

Clinical trials of pamiparib include:

Phase 3 trial in China of pamiparib as maintenance versus placebo in patients with platinum-sensitive recurrent ovarian cancer (NCT03519230);

Phase 2 trial of pamiparib in patients with metastatic castration-resistant prostate cancer with homologous recombination deficiency (NCT03712930);

Phase 2 trial in China of pamiparib in patients with metastatic HER2-negative breast cancer with BRCA mutation (NCT03575065);

Phase 2 trial of pamiparib in patients with advanced or inoperable gastric cancer (NCT03427814);

Phase 1/2 trial in China of pamiparib in patients with advanced ovarian cancer, fallopian cancer, and primary peritoneal cancer or advanced triple negative breast cancer (NCT03333915);

Phase 1b/2 trial of pamiparib in combination with radiation therapy and/or temozolomide in patients with first-line or recurrent/refractory glioblastoma (NCT03150862);

Phase 1b trial of pamiparib in combination with temozolomide in patients with locally advanced or metastatic solid tumors (NCT03150810); and

Phase 1b trial of pamiparib in combination with tislelizumab for a variety of solid tumor malignancies (NCT02660034).