On January 17, 2023 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company,reported that it will share clinical data and patient-reported outcomes for its PD-1 inhibitor, tislelizumab, at the 2023 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium, notably, an oral presentation for interim results of the global pivotal phase 3 trial RATIONALE 305 of tislelizumab in combination with chemotherapy in first-line gastric or gastroesophageal junction (G/GEJ) cancer (Press release, BeiGene, JAN 17, 2023, View Source [SID1234626282]). At the interim analysis, RATIONALE 305 trial met one of the primary endpoints of overall survival (OS) in patients with G/GEJ whose tumors express PD-L1.

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"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," Mark Lanasa, M.D., Chief Medical Officer, Solid Tumors at BeiGene. "We look forward to sharing additional results as the study continues, including results for the intent-to-treat population."

Analyses from additional studies of tislelizumab as monotherapy and in combination will be presented at the conference.

Tislelizumab presentations 2023 ASCO (Free ASCO Whitepaper) 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, 2023 Oral 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-Asia subgroup

Jan 19, 2023 Poster Session A (12:00pm and 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, 2023 Rapid Abstract Session (7:00am – 7:45am, PST)
About Tislelizumab

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 U.S. and European Union (E.U.) regulators; for unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) in the U.S.; for non-small cell lung cancer and unresectable recurrent locally advanced or metastatic ESCC in the E.U.

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 China.

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 China, were enrolled and randomized 1:1 to receive either tislelizumab and chemotherapy or placebo and chemotherapy.

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 Asia-Pacific, Europe, and North America. Patients were randomized 1:1 to receive either tislelizumab plus chemotherapy or placebo plus chemotherapy.