China-based BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) announced the presentation of new data at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The data highlights the range of BeiGene’s research expertise and the productivity of one of the industry’s largest research and development teams. The results include data for BeiGene’s cornerstone therapies, Brukinsa (zanubrutinib) and tislelizumab, as well as early results for BeiGene’s OX40 agonist and BCL-2 inhibitor.
Tislelizumab’s Latest Clinical Status: RATIONALE-301 Analysis
In a risk factor analysis of RATIONALE-301, a Phase III study comparing tislelizumab to sorafenib as a first-line treatment for unresectable hepatocellular carcinoma, tislelizumab showed numerically longer median overall survival (OS) in several biomarker subgroups. In a European/North American (EU/NA) subgroup analysis, tislelizumab demonstrated a numerically longer median OS, median duration of response, and a higher objective response rate (ORR) compared to sorafenib. Additionally, tislelizumab had a lower incidence of grade ≥3 treatment-emergent adverse events (TEAEs), grade ≥3 treatment-related TEAEs (TRAEs), and TRAEs leading to discontinuation.
BRUKINSA’s Updated Analysis in ROSEWOOD Study
An updated analysis of the ROSEWOOD study showed that BRUKINSA in combination with obinutuzumab demonstrated clinically meaningful activity and a manageable safety profile in patients with heavily pretreated relapsed/refractory (R/R) follicular lymphoma (FL). BeiGene will detail the trial design of its ongoing Phase III MAHOGANY study of BRUKINSA plus obinutuzumab versus lenalidomide plus rituximab in R/R FL or marginal zone lymphoma during the Trials in Progress session.
Early Study Results for OX40 Agonist and BCL-2 Inhibitor
BeiGene’s investigational BGB-A445, a novel monoclonal antibody OX40 agonist, is being studied as a single agent or in combination with tislelizumab in patients with advanced solid tumors. First-in-human results presented at ASCO showed that BGB-A445 monotherapy or in combination with tislelizumab was generally well-tolerated and demonstrated preliminary antitumor activity. The dose expansion phase is currently enrolling patients into non-small cell lung cancer and head and neck squamous cell carcinoma cohorts.
BGB-11417, a potent and highly selective BCL-2 inhibitor, showed that single agent treatment was well tolerated at all tested doses up to 640 mg/d in B-cell malignancies, with no dose-dependent toxicity increase. BGB-11417 monotherapy also showed promising initial efficacy results in R/R chronic lymphocytic leukemia/small lymphocytic lymphoma, with patients achieving responses at lower dose levels.-Fineline Info & Tech
