Linifanib Fails to Meet Overall Survival Endpoint for Advanced Hepatocellular Carcinoma

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According to a new study published in the Journal of Clinical Oncology, linifanib and sorafenib had similar overall survival for the treatment of patients with advanced hepatocellular carcinoma (HCC), while sorafenib was more safe.

For the open-label phase 3 study, researchers enrolled 1,035 patients with a median age of 60 years old with advanced HCC and randomly assigned them to receive linifanib 17.5mg orally once daily or sorafenib 400mg orally twice daily.

Linifanib is a novel, potent tyrosine kinase inhibitor currently under development by Abbott Laboratories. Of those enrolled, 66.6% were Asian, 65.2% had an ECOG performance score of 0, 49.1% had hepatitis B infection, and 70.1% had vascular invasion or extrahepatic spread.

Results showed a median overall survival of 9.1 months (95% CI: 8.1 - 10.2) with linifanib and 9.8 months (95% CI: 8.3 - 11.0; HR = 1.046; 95% CI: 0.896 - 1.221) with sorafenib. The median time to progression was found to be 5.4 months (95% CI: 4.2 - 5.6) and 4.0 months (95% CI: 2.8 - 4.2: HR = 0.759; 95% CI: 0.643 - 0.895; P = 0.001).

In addition, objective response rates were 13.0% in the linifanib group and 6.9% in the sorafenib group. In regard to safety, serious adverse effects were more common in the linifanib arm and were more likely to cause discontinuation and dose modification (P < 0.001). 

Tamoxifen significantly reduces breast cancer incidence among women at high risk.
Linifanib and sorafenib had similar overall survival for the treatment of advanced HCC.
This open-label phase III trial evaluated efficacy and tolerability of linifanib versus sorafenib in patients with advanced hepatocellular carcinoma (HCC) without prior systemic therapy. Linifanib and sorafenib had similar OS in advanced HCC.

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