BeiGene Announces Positive Results from Global Phase 3 Trial of Tislelizumab in First-Line Unresectable Hepatocellular Carcinoma

BEIJING, China, CAMBRIDGE, Mass.

HCC is the sixth most common cancer type worldwide, with more than 900,000 new cases in 2020, and despite advances in screening, surveillance methods, and imaging, more than two-thirds of HCC patients are diagnosed at the time of diagnosis.

"Patients with unresectable hepatocellular carcinoma have an extremely poor prognosis, with a median expected survival of only one year

RATIONALE 301 (NCT03412773) is a randomized, open-label, global Phase 3 study to evaluate tislelizumab versus sorafenib as first-line treatment in adult patients with unresectable HCC

About Tislelizumab

Tislelizumab (Chinese trade name: Baizean®) is a humanized IgG4 anti-programmed death receptor-1 (PD-1) monoclonal antibody whose structure has been specially modified to minimize Binds to Fcγ receptors on macrophages to help human immune cells recognize and kill tumors

Tislelizumab is the first drug in development on BeiGene's immuno-oncology biologics platform and is currently undergoing single-agent and combination clinical trials to develop a broad range of indications for solid tumors and hematological tumors

The global clinical development program of tislelizumab has enrolled more than 11,000 subjects in 30 countries and regions

About BeiGene Oncology

BeiGene continuously promotes the development of best-in-class and first-in-class clinical drug candidates through independent research and development or in collaboration with like-minded partners, and is committed to providing effective, accessible and affordable medicines to patients around the world

At the same time, BeiGene is also working with other innovative companies to jointly advance the research and development of innovative therapies to meet global health needs

In January 2021, BeiGene and Novartis announced a collaboration granting Novartis the right to develop, manufacture and commercialize BeiGene's anti-PD-1 antibody tislelizumab in North America, Europe and Japan

About BeiGene

BeiGene is a global biotechnology company focused on the development and commercialization of innovative, affordable oncology medicines designed to improve outcomes and access to patients worldwide

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including HCC's clinical development plan, BeiGene's anticipated clinical development progress, regulatory milestones and commercialization progress, and BeiGene's plans mentioned under the headings "About BeiGene Oncology" and "About BeiGene" , commitment, vision and goals

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Source: BeiGene