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Zai Lab Presents Interim Results of its ongoing Phase 2 study of ZL-2301 (brivanib) in Chinese Patients with Advanced Hepatocellular Carcinoma (HCC) at the 21st Annual Meeting of the Chinese Society of Clinical Oncology
Results demonstrate anti-tumor activity and manageable safety profile of the two dosing regimens of ZL-2301 tested in the trial
Plan to pursue study to evaluate ZL-2301 in combination with anti-PD-1 therapy
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.
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
About ZL-2301 (brivanib)
ZL-2301 (brivanib) is an oral, small molecule dual target tyrosine kinase inhibitor, or TKI.
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