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Zai Lab Presents Results of the First Phase I Clinical Trial of Niraparib in China at AACR

On April 2, 2019 (Eastern Standard Time), Zai Lab (NASDAQ: ZLAB) published the results of the first phase I clinical trial of Niraparib (ZL-2306) in Chinese ovarian cancer patients at the American Association for Cancer Research (AACR) Annual Meeting 2019. This study was led by Prof. Wu Xiaohua and Prof. Zhang Jian, Shanghai Cancer Center affiliated with Fudan University, and conducted in several hospitals in China.

Founded in 1907, AACR is the world's first and largest scientific organization dedicated to advancing cancer research. AACR Annual Meeting is one of the largest cancer research conferences in the world, attracting nearly 20,000 professionals from all over the world. The AACR Annual Meeting 2019 was held in Atlanta, USA, from March 29 to April 3.

The results presented by Zai Lab demonstrated that the pharmacokinetics (PK) characteristics of niraparib in Chinese patients are consistent with its known profile in Caucasian patients. The drug exposure of niraparib increased dose-proportionally, showing linear pharmacokinetics, which facilitates clinicians to estimate its exposure and perform dose adjustment. A notably longer terminal elimination half-life (T1/2~35h) of niraparib comparing to other PARP inhibitors makes it possible for patients to take the drug only once daily and helps to improve their compliance. Population pharmacokinetics showed that ethnicity had little impact on the PK profile of niraparib, while the effects of baseline body weight on niraparib exposure were relatively modest, except for extreme weights. The safety profile of niraparib in Chinese ovarian cancer (OC) patients is similar to that in Caucasian patients. Niraparib was generally well tolerated in patients, and adverse events were effectively managed. Good PK characteristics lay a foundation for its better efficacy and provide a theoretical basis for clinicians to effectively control adverse events. 

In addition, in order to further explore the efficacy of niraparib in Chinese OC patients, Prof. Wu Xiaohua from Shanghai Cancer Center affiliated with Fudan University, is leading a multi-center phase III clinical trial of niraparib as a second-line maintenance therapy in platinum-sensitive recurrent (PSR) OC patients in collaboration with several hospitals in China (NORA study; patients enrollment completed). 

At the same time, Prof. Wu Lingying, from Cancer Hospital affiliated with Chinese Academy of Medical Sciences, is leading a multi-center Phase III clinical trial of niraparib as a first-line maintenance therapy in platinum-sensitive OC patients (PRIME study). Results of these clinical trials will be disclosed at academic conferences at home and abroad in the future.

This first phase I clinical study of niraparib in Chinese OC patients is a randomized, open-label, multi-center study jointly conducted by a number of hospitals in China. Here, we would like to particularly thank Prof. Wu Xiaohua and Prof. Zhang Jian, Shanghai Cancer Center of Fudan University; Prof. Gao Yunong, Beijing Cancer Hospital of Peking University; Prof. Lou Ge, Cancer Hospital of Harbin Medical University, Prof. Yin Rutie, West China Second University Hospital of Sichuan University, and other researchers for their concerted efforts. 

About Niraparib

Niraparib (ZL-2306) is a highly potent and selective oral, once-daily small molecule poly (ADP-ribose) PARP 1/2inhibitor. It was approved in March 2017 by the FDA in the United States and in November 2017 by the EMA in the European Union under the trade name ZEJULA® as a maintenance treatment for women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Based on the approval status in the United States and European Union by our partner, Tesaro, which was recently acquired by GSK, Zai Lab obtained the approval for marketing Niraparib in Hong Kong in October 2018.

About Zai Lab

Zai Lab (NASDAQ: ZLAB) is a Shanghai-based innovative commercial stage biopharmaceutical company focused on bringing transformative medicines for cancer, autoimmune and infectious diseases to patients in China and around the world. Zai Lab’s experienced team has secured partnerships with leading global biopharma companies, generating a broad pipeline of innovative drug candidates targeting the fast-growing segments of China's pharmaceutical market and addressing unmet medical needs. Zai Lab's vision is to become a fully integrated biopharmaceutical company, discovering, developing, manufacturing and commercializing its partners' and its own products in order to impact human health worldwide.