On September 26, 2018 Zai Lab Limited (NASDAQ: ZLAB), a Shanghai-based innovative biopharmaceutical company, reported its interim results of its Phase 2 study of ZL-2301 (brivanib) in Chinese patients with previously-treated advanced hepatocellular carcinoma (HCC) (Press release, Zai Laboratory, SEP 26, 2018, View Source;p=RssLanding&cat=news&id=2368997 [SID1234530331]). Results from the study show ZL-2301 continues to demonstrate evidence of anti-tumor activity with a manageable safety profile in Chinese patients. The interim data were presented at the 21st Annual Meeting of the Chinese Society of Clinical Oncology (CSCO) on Sept. 22, 2018, at the Xiamen International Conference and Exhibition Center (XICEC) in Xiamen, China.
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In the multi-center, open-label Phase 2 trial, 90 patients were enrolled to receive either 800 mg of ZL-2301 once-daily (QD) or 400 mg of ZL-2301 twice-daily (BID), administered orally. The primary endpoints in the trial are: (1) disease control rate (DCR) at 12 weeks from randomization, defined as the percentage of patients with a complete response, partial response or stable disease, and (2) time to disease progression (TTP).
The interim analysis was based on 75 patients (36 on 800mg QD; 39 on 400mg BID). The 12 weeks DCR was 41.7% in the 800mg QD arm and 35.9% in the 400mg BID arm. TTP was 4.2 months (95% CI, 2.8-4.2) in 800mg QD arm and 2.8 months (95% CI, 1.4-4.2) in the 400mg BID arm. ZL-2301 was relatively well-tolerated in the study; its toxicity profile appears in-line with that of the VEGFR inhibitor drug class.
Dr. Shukui Qin, Executive Member of the Asian Clinical Oncology Society, Senior Vice President of Chinese Society of Clinical Oncology and Lead Investigator for ZL-2301 study, commented, "This is a well conducted clinical trial that produced additional data to better characterize the clinical profile of ZL-2301 in Chinese patients. The data helped to set the foundation for further development of ZL-2301 as a potential therapy for HCC which are still in dire need of additional treatment options."
The efficacy and tolerability results of the study are in-line with our expectations in this heavily pre-treated HCC population. Given the large, unmet needs in HCC, a common, difficult to treat cancer, primarily driven by hepatitis B infection in China, and the rapidly changing landscape in HCC, Zai Lab plans to conduct a combination study to evaluate ZL-2301 with anti-PD1 therapy for HCC patients in China.
About ZL-2301 (brivanib)
ZL-2301 (brivanib) is an oral, small molecule dual target tyrosine kinase inhibitor, or TKI. Zai Lab licensed exclusive rights for China, Hong Kong, Macau and Taiwan from Bristol Myers Squibb. ZL-2301 has been tested in four Phase III studies in hepatocellular cancer (HCC) and showed anti-tumor activity and a manageable safety profile. Based on Zai Lab’s review of the results from Bristol-Myers Squibb’s development program for ZL-2301, its understanding of the etiology and current standard of care of HCC in Chinese patients and its ongoing research, Zai Lab believes that ZL-2301 has the potential to be an effective treatment option for Chinese HCC patients and merits further clinical development. In the second quarter of 2017 Zai Lab initiated a Phase II trial of ZL-2301 as a second-line treatment for advanced HCC patients in China.