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

BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, will share clinical data and patient-reported outcomes for its PD-1 inhibitor, tislelizumab, at the 2023 ASCO 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. 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.

“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 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.

About BeiGene

BeiGene is a global biotechnology company that is developing and commercializing innovative and affordable oncology medicines to improve treatment outcomes and access for far more patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 9,000 colleagues spans five continents, with administrative offices in Cambridge, U.S., & Basel, Switzerland & Beijing, China. To learn more about BeiGene, please visit www.beigene.com and follow us on Twitter at @BeiGeneGlobal.

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 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, BeiGene's advancement of anticipated clinical development, regulatory milestones and commercialization of tislelizumab, and BeiGene’s plans, commitments, aspirations and goals under the heading “About BeiGene.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene's reliance on third parties to conduct drug development, manufacturing and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and the impact of the COVID-19 pandemic on BeiGene’s clinical development, regulatory, commercial, manufacturing, and other operations, as well as those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.

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