BeiGene Presents New Research from Tislelizumab Global Development Program at 2023 ASCO Gastrointestinal Cancers Symposium
Jan 17, 2023 5:00 PM
Oral presentation for RATIONALE 305 showed improved survival and manageable safety profile for tislelizumab and chemotherapy in gastric or gastroesophageal junction cancer with PD-L1 expression
“With more than one million gastric cancer cases and approximately 770,000 deaths in 2020, we have a meaningful opportunity to advance care for these patients. We are pleased to report a significant survival benefit for tislelizumab and chemotherapy at this interim analysis of the RATIONALE 305 trial,”
Analyses from additional studies of tislelizumab as monotherapy and in combination will be presented at the conference.
Tislelizumab presentations 2023 ASCO Gastrointestinal Cancers Symposium
Abstract 286 Phase 3 Study of Tislelizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as First-line Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Jan 19, 2023Oral Presentation ( 4:15pm, PST)
Abstract 340 Randomized, global, phase 3 study of tislelizumab plus chemotherapy versus placebo plus chemotherapy as first-line treatment for advanced or metastatic esophageal squamous cell carcinoma (RATIONALE-306): non-
Jan 19, 2023Poster Session A ( 12:00pmand 4:45pm, PST)
Abstract 495 Tislelizumab versus sorafenib in first-line treatment of unresectable hepatocellular carcinoma: Impact on health-related quality of life in RATIONALE-301 population
Jan 20, 2023Rapid Abstract Session ( 7:00am– 7:45am, PST)
Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to Fcγ receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.
Tislelizumab is the first investigational medicine from BeiGene’s immuno-oncology biologics program and is being evaluated in solid tumor and hematologic malignancies, as monotherapy and in combination.
The global tislelizumab clinical development program includes more than 11,500 subjects enrolled to-date in 21 registration-enabling trials, from more than 30 countries and regions.
Biologics License Applications (BLA) for tislelizumab are under review with
Tislelizumab is approved by the China NMPA as a treatment for nine indications and additional three supplemental BLAs under review at CDE. Tislelizumab is not approved for use outside of
About the Clinical Trials
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 hepatocellular cancer (HCC), G/GEJ adenocarcinoma. The primary endpoint of the study is non-inferiority of Overall Survival between the two treatment groups. The key secondary endpoint is Overall Response Rate, as assessed by Blinded Independent Review Committee (BIRC) per RECIST v1.1. Other secondary endpoints include other efficacy assessments such as Progression Free Survival, Duration of Response, and Time to Progression per BIRC, as well as measures of health-related quality of life, and safety and tolerability.
RATIONALE 305 (NCT03777657) is a randomized, double-blind, placebo-controlled global Phase 3 trial comparing the efficacy and safety of tislelizumab combined with chemotherapy and placebo combined with chemotherapy as a first-line treatment for patients with locally advanced, unresectable or metastatic G/GEJ adenocarcinoma. The primary endpoint of the trial is OS. Secondary endpoints include progression-free survival (PFS), overall response rate (ORR), duration of response (DoR), and safety. A total of 997 patients from 13 countries and regions globally, including close to 50 percent from outside of
RATIONALE 306 (NCT03783442) is a randomized, placebo-controlled, double-blind, global Phase 3 study to evaluate the efficacy and safety of tislelizumab in combination with chemotherapy as a first-line treatment in patients with advanced or metastatic ESCC. The primary endpoint of the trial is overall survival (OS). Secondary endpoints include progression free survival, overall response rate, and duration of response per RECIST v1.1, as well as health-related quality of life measures and safety.
The trial enrolled 649 patients at research centers across
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 statements regarding the potential for tislelizumab to treat patients with gastrointestinal cancers including G/GEJC, HCC, or esophageal squamous cell carcinoma, plans for regulatory approvals for tislelizumab in G/GEJC, HCC, or esophageal squamous cell carcinoma,
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