BeiGene Presentations at ESMO 2023 Demonstrate Robust Clinical Strategy for Tislelizumab as Monotherapy and in Combination with Pipeline Assets

Rhea-AI Summary

BeiGene presents promising data on tislelizumab at ESMO Congress 2023

Positive

• Final analysis of Phase 3 RATIONALE-305 study shows tislelizumab plus chemotherapy as a first-line treatment for advanced gastric or gastroesophageal junction adenocarcinoma
• Final analysis of Phase 3 RATIONALE-315 study shows neoadjuvant tislelizumab plus chemotherapy in patients with resectable Stage II-IIIA non-small cell lung cancer
• TEVIMBRA® (tislelizumab) recently approved in the EU for the treatment of esophageal squamous cell carcinoma

Negative

• None.

Two late-breaking abstracts highlight tislelizumab plus chemotherapy combination strategy in solid tumors with high unmet need

Additional presentations showcase potential of biology-driven tislelizumab combination approaches with BeiGene pipeline molecules

BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced the presentation of promising new data showcasing BeiGene’s robust, science-driven solid tumor portfolio of commercialized and pipeline medicines at the European Society for Medical Oncology (ESMO) Congress 2023.

Highlights include the presentations of two late-breaking abstracts for tislelizumab, an anti-PD-1 antibody and the first medicine to emerge from BeiGene’s immuno-oncology biologics program:

• Final analysis from the global, Phase 3 RATIONALE-305 study (NCT03777657) evaluating tislelizumab plus chemotherapy as a first-line treatment of advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJC)
• Final analysis of pathological response to neoadjuvant tislelizumab plus chemotherapy in patients with resectable Stage II-IIIA non-small cell lung cancer (NSCLC) in results from the Phase 3 RATIONALE-315 study (NCT04379635)

“At ESMO 2023, we look forward to presenting results from several clinical trials of tislelizumab in combination with other therapies across multiple disease areas and lines of treatment,” said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene. “Tislelizumab is the cornerstone of BeiGene’s diverse pipeline of pan-solid tumor programs for the next wave of immuno-oncology targets. We are delighted to have recently regained the global rights to this important medicine and remain dedicated to following the science and data to advance new combination strategies for the treatment of solid tumors.”

TEVIMBRA^® (tislelizumab) was recently approved in the European Union (EU) as monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior platinum-based chemotherapy. Additionally, the U.S. Food and Drug Administration (FDA) recently accepted for review a Biologics License Application for tislelizumab as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC.

More details on BeiGene’s abstracts are available in the ESMO Programme.

Presentations of Company-Sponsored Trials

Tislelizumab

• Tislelizumab (TIS) Plus Chemotherapy (Chemo) vs Placebo (PBO) Plus Chemo as First-Line (1L) Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (GC/GEJC): Final Analysis Results of the RATIONALE-305 Study (Abstract #LBA80)
  • Mini oral presentation, Saturday, October 21, 5:25-5:30 PM CEST
• Pathological Response to Neoadjuvant Tislelizumab (TIS) Plus Platinum-Doublet (PtDb) Chemotherapy (CT) in Resectable Stage II-IIIA NSCLC Patients (pts) in the Phase 3 (Ph3) RATIONALE-315 Trial (Abstract #LBA58)
  • Mini oral presentation, Monday, October 23, 2:55-3:00 PM CEST
• Randomized, Global, Phase 3 Study of Tislelizumab (tis) + Chemotherapy (chemo) vs Placebo (PBO) + Chemo as First-line (1L) Treatment for Advanced/Metastatic Esophageal Squamous Cell Carcinoma (ESCC): RATIONALE-306 Study Update (Abstract #1514P)
  • Poster presentation, Monday, October 23
• Long-term Follow-up of a Phase 2 Study of Tislelizumab (TIS) Monotherapy in Patients (pts) With Previously Treated, Locally Advanced, Unresectable or Metastatic Microsatellite Instability-high (MSI-H) or Mismatch Repair-deficient (dMMR) Solid Tumors. BGB-A317-209 Study (Abstract #1057P)
  • Poster presentation, Monday, October 23

Ociperlimab Development Program

• AdvanTIG-203: Phase 2 Randomized, Multicenter Study of Ociperlimab (OCI) + Tislelizumab (TIS) in Patients (pts) With Unresectable, Locally Advanced, Recurrent/Metastatic Esophageal Squamous Cell Carcinoma (ESCC) and Programmed Cell Death-Ligand 1 (PDL1) Positivity (Abstract #1020MO)
  • Mini oral presentation, Saturday, October 21, 4:30-4:35 PM CEST
• AdvanTIG-206: Phase 2 randomized open-label study of ociperlimab (oci) + tislelizumab (tis) + BAT1706 (bevacizumab biosimilar) versus tis + BAT1706 in patients (pts) with advanced hepatocellular carcinoma (HCC) (Abstract #945MO)
  • Mini oral presentation, Saturday, October 21, 4:30-4:35 PM CEST
• AdvanTIG-202: Phase 2 Randomized, Multicenter, Open-Label Study of Tislelizumab (tis) With or Without Ociperlimab (oci) in Patients (pts) With Previously Treated Recurrent/Metastatic (R/M) Cervical Cancer (CC) (Abstract #744MO)
  • Mini oral presentation, Sunday, October 22, 10:55-11:00 AM CEST
• AdvanTIG-105: Phase 1b Dose-expansion Study of Ociperlimab (OCI) + Tislelizumab (TIS) with Chemotherapy (CT) in Patients (pts) with Metastatic Esophageal Squamous Cell Carcinoma (ESCC) and Esophageal Adenocarcinoma (EAC) (Abstract #1533P)
  • Poster presentation, Monday, October 23

Additional Pipeline Assets

• Zanidatamab (zani) Plus Chemotherapy (chemo) and Tislelizumab (tis) as First-line (1L) Therapy for Patients (pts) With Advanced HER2-positive (+) Gastric/Gastroesophageal Junction Adenocarcinoma (GC/GEJC): Updated Results From a Phase 1b/2 Study (Abstract #1518P)
  • Poster presentation, Monday, October 23
• Phase (Ph) 1/2 Study of Sitravatinib (sitra) Alone or With Tislelizumab (tis) in Advanced Hepatocellular Carcinoma (HCC) and Gastric/Gastroesophageal Junction Cancer (GC/GEJC) (Abstract #948P)
  • Poster presentation, Monday, October 23

About Tislelizumab

Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody, with high affinity and binding specificity against PD-1, specifically designed to minimize binding to Fc-gamma (Fcγ) 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.^i,ii,iii,iv

The tislelizumab development program encompasses 21 registration-enabling clinical trials in more than 30 countries and regions. To date, BeiGene has announced positive readouts from 10 Phase 3 pivotal studies across multiple tumor types and disease settings, such as NSCLC, small cell lung cancer, gastric cancer, ESCC, hepatocellular cancer, and nasopharyngeal cancer. More information on the clinical trial program for tislelizumab can be found at: https://www.beigene.com/en-us/science-and-product-portfolio/pipeline.

Tislelizumab is currently under review by the FDA and received approval by the European Commission for advanced or metastatic ESCC after prior chemotherapy. Additionally, the FDA recently accepted for review a Biologics License Application for tislelizumab as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC. The EMA is reviewing a marketing authorization application for tislelizumab as a treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy, and in combination with chemotherapy for previously untreated locally advanced or metastatic NSCLC.

Regulatory submissions for tislelizumab are also under review by authorities in Australia, Brazil, China, Korea, Israel, New Zealand, Singapore, Switzerland, and the U.K. Tislelizumab is approved as a treatment in 11 indications in China and is the leading PD-1 inhibitor in the country.

About BeiGene

BeiGene is a global biotechnology company that is discovering and developing innovative oncology treatments that are more affordable and accessible to cancer 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 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, Cambridge, and U.S. To learn more about BeiGene, please visit www.beigene.com and follow us on LinkedIn and X (formerly known as Twitter).

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 BeiGene’s advancement, anticipated clinical development, regulatory milestones and commercialization of tislelizumab, ociperlimab and other pipeline assets; BeiGene’s ability to advance new combination strategies for the treatment of solid tumors; the general future of BeiGene’s pipeline and programs; 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, commercialization, 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 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.

ⁱ Desai J et al. Ann Oncol. 2017;28(suppl_5):v122–v141.
ⁱⁱ Zhang T et al. Cancer Immunol Immunother. 2018;67:1079–1090.
ⁱⁱⁱ Arlauckas SP et al. Sci Transl Med. 2017;9:eaal3604.
^iv Dahan R et al. Cancer Cell. 2015;28:285–295.

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Investor Contact:

Liza Heapes

+1 857-302-5663

ir@beigene.com

Media Contact:

U.S. Media

Kyle Blankenship

+1 667-351-5176

media@beigene.com

EU Media

Maryline Iva

+41 61 685 2090

media@beigene.com

Source: BeiGene, Ltd.

FAQ

What were the results of the Phase 3 RATIONALE-305 study?

The final analysis showed that tislelizumab plus chemotherapy is effective as a first-line treatment for advanced gastric or gastroesophageal junction adenocarcinoma.

What were the results of the Phase 3 RATIONALE-315 study?

The final analysis showed that neoadjuvant tislelizumab plus chemotherapy is effective in patients with resectable Stage II-IIIA non-small cell lung cancer.

What is TEVIMBRA® (tislelizumab) used for?

TEVIMBRA® (tislelizumab) is approved for the treatment of esophageal squamous cell carcinoma.

What is the significance of these findings?

These findings demonstrate the potential of tislelizumab in the treatment of solid tumors, particularly in advanced gastric or gastroesophageal junction adenocarcinoma and resectable Stage II-IIIA non-small cell lung cancer.

Has tislelizumab been approved in the US?

The US FDA has accepted a Biologics License Application for tislelizumab as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic esophageal squamous cell carcinoma.