Therapy Areas: Oncology
BeiGene Touts Positive Global Phase 3 Trial Results for PD-1 Inhibitor Tislelizumab in First-Line Unresectable Hepatocellular Cancer
10 August 2022 - - The global Phase 3 RATIONALE 301 trial with tislelizumab met its primary endpoint of non-inferior Overall Survival versus sorafenib as a first-line treatment in adult patients with unresectable hepatocellular carcinoma, Chinese biotechnology company BeiGene (NASDAQ: BGNE) (HKEX: 06160) (SSE: 688235) said.

The safety profile for tislelizumab was consistent with previous studies and no new safety signals were reported. More than 600 patients in the US, Europe, and Asia participated in the study.

HCC is the sixth most common type of cancer worldwide, accounting for more than 900,000 new cases in 2020i, and despite improvements in screening, surveillance rules, and imaging, more than two-thirds of patients with HCC present with advanced disease at diagnosisii.

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

The primary endpoint of the study is non-inferiority of OS between the two treatment groups.

The key secondary endpoint is Overall Response Rate, as assessed by Blinded Independent Review Committee per RECIST v1.1.

Other secondary endpoints include other efficacy assessments such as Progression-Free Survival, Durability of Response, and Time to Progression per BIRC, as well as measures of health-related quality of life, and safety and tolerability.

Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to Fc-gamma receptors on macrophages, helping to aid the body's immune cells to detect and fight tumors.

In pre-clinical studies, binding to Fcγ receptors on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.

Tislelizumab is the first drug from BeiGene's immuno-oncology biologics program and is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

The global tislelizumab clinical development program includes more than 11,000 subjects enrolled to-date in 30 countries and regions. BeiGene has initiated or completed 22 registration-enabling clinical trials.