BeiGene Says Tislelizumab To Treat Hepatocellular Cancer Meets Primary Goal In Late-stage Study

BeiGene (BGNE) on Tuesday said late-stage RATIONALE 301 study of tislelizumab to treat adults with hepatocellular cancer met its primary goal.

RATIONALE 301 is a Phase 3 study of tislelizumab compared with Bayer/Onyx Pharma's sorafenib as a first-line treatment in adult patients with unresectable hepatocellular carcinoma (HCC). The primary endpoint of the study was non-inferiority of overall survival between the two treatment groups.

In the study with more than 600 patients participated, the safety profile for tislelizumab was consistent with previous studies and no new safety signals were reported, the company said.

Tislelizumab is currently being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

Last year, BeiGene and Novartis had announced partnership to co-develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.

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