European Commission Approves BeiGene’s TEVIMBRA for First-Line Treatment of Advanced/Metastatic Esophageal Squamous Cell Carcinoma and Gastric or Gastroesophageal Junction Cancer

Rhea-AI Summary

BeiGene's TEVIMBRA received European Commission approval for first-line treatment of advanced esophageal squamous cell carcinoma (ESCC) and gastric/gastroesophageal junction cancer in combination with chemotherapy. The approval is based on two Phase 3 studies showing significant survival benefits. In the RATIONALE-306 study for ESCC, median overall survival was 17.2 months for TEVIMBRA with chemotherapy versus 10.6 months for placebo. In the RATIONALE-305 study for G/GEJ cancer, median overall survival was 15.0 months for TEVIMBRA combination versus 12.9 months for placebo, showing a 20% reduction in death risk.

Positive

• Significant survival improvement in ESCC: 17.2 vs 10.6 months (34% reduction in death risk)
• Notable survival benefit in G/GEJ cancer: 15.0 vs 12.9 months (20% reduction in death risk)
• Expansion to two new indications in European market
• Strong efficacy data in PD-L1 ≥ 5% population with 38% reduction in death risk for ESCC

Negative

• Presence of Grade 3 or 4 adverse reactions including neutropenia, thrombocytopenia, and anemia

Insights

Medical Research Analyst

The European Commission's approval of TEVIMBRA for two new first-line cancer indications represents a significant advancement in treatment options. The Phase 3 trial results show remarkable survival benefits: In ESCC, median overall survival improved from 10.6 to 17.2 months (a 34% reduction in death risk) and in G/GEJ cancer, from 12.9 to 15.0 months (a 20% reduction in death risk). These improvements are particularly notable in PD-L1 ≥ 5% populations, where the risk reduction was even more pronounced at 38% for ESCC and 29% for G/GEJ cancer.

The robust safety profile across 2,800+ patients and existing EU approvals for other indications strengthen TEVIMBRA's market position. This expansion into first-line treatments for two aggressive cancers significantly broadens the drug's commercial potential and patient reach, particularly important given the current treatment options for these conditions.

Market Research Analyst

This regulatory milestone substantially expands BeiGene's market opportunity in Europe. With six EU approvals in just over a year and more than 1.3 million patients treated globally, TEVIMBRA is proving to be a cornerstone product in BeiGene's oncology portfolio. The expansion into first-line treatments is particularly valuable as it allows earlier intervention and typically longer treatment duration, potentially driving higher revenue per patient. The strong efficacy data in both indications, especially in PD-L1 positive patients, positions TEVIMBRA competitively in the European immunotherapy market. This approval strengthens BeiGene's commercial presence in Europe and supports its global growth strategy, reflected in its planned transformation to BeOne Medicines.

New indications based on two Phase 3 studies demonstrating statistically significant overall survival benefit for patients treated with TEVIMBRA in combination with chemotherapy

SAN MATEO, Calif.--(BUSINESS WIRE)-- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company that intends to change its name to BeOne Medicines, today announced that the European Commission has approved TEVIMBRA^® (tislelizumab) in combination with chemotherapy for the first-line treatment of esophageal squamous cell carcinoma (ESCC) and gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.

“Patients diagnosed with advanced gastric and esophageal cancers confront median survival times measured in months, not years—highlighting the urgent need for more effective treatment options,” said Prof. Florian Lordick, Director and Professor of Oncology of the University Cancer Center Leipzig, Germany. “The compelling data from the RATIONALE-305 and 306 trials underscore the unique clinical profile of tislelizumab and its potential to deliver meaningful improvements in outcomes for eligible patients, offering new hope where it’s needed most.”

In ESCC, the expanded indication is for TEVIMBRA in combination with platinum-based chemotherapy for the first-line treatment of adult patients with unresectable, locally advanced or metastatic cancer whose tumors express PD-L1 with a tumor area positivity (TAP) score ≥ 5%. In G/GEJ adenocarcinoma, the expanded indication is for TEVIMBRA in combination with platinum- and fluoropyrimidine-based chemotherapy for the first-line treatment of adult patients with HER2-negative locally advanced unresectable or metastatic cancer whose tumors express PD-L1 with a TAP score ≥ 5%.

“As the cornerstone of our solid tumor portfolio, TEVIMBRA is central to BeiGene’s commitment to delivering innovative treatments to as many people living with cancer as possible, with more than 1.3 million patients already treated with the medicine worldwide," said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene. "In just over a year, we have achieved approvals in the European Union across six indications, and we look forward to working to ensure that patients across Europe have rapid and broad access to TEVIMBRA.”

In first-line ESCC, the extension of indication application was based on results from BeiGene’s RATIONALE-306 (NCT03783442), a randomized, placebo-controlled, double-blind, global Phase 3 study to evaluate the efficacy and safety of TEVIMBRA in combination with chemotherapy as a first-line treatment in patients with unresectable, locally advanced recurrent or metastatic ESCC. The study enrolled 649 patients at research centers across Europe, North America and Asia-Pacific. The study met its primary endpoint, with first-line TEVIMBRA in combination with chemotherapy resulting in statistically significant and clinically meaningful OS benefit compared with placebo plus chemotherapy in the intent-to-treat population. The median OS was 17.2 months for TEVIMBRA with chemotherapy versus 10.6 months for placebo plus chemotherapy (HR: 0.66 [95% CI, 0.54-0.80, 1-sided p-value of < 0.0001]), a 34% reduction in the risk of death. Three-year OS in the PD-L1 ≥ 5% population was also substantially improved in favor of the TEVIMBRA arm (median 19.1 versus 10.0 months, respectively; HR: 0.62 [95% CI, 0.49-0.79]), demonstrating a 38% reduction in the risk of death.

The extension of indication application for first-line G/GEJ cancer was based on results from BeiGene’s RATIONALE-305 (NCT03777657), a randomized, double-blind, placebo-controlled, global Phase 3 trial to evaluate the efficacy and safety of TEVIMBRA in combination with chemotherapy as a first-line treatment for patients with advanced unresectable or metastatic G/GEJ cancer. The study enrolled 997 patients at research centers across Europe, North America and Asia-Pacific. The study met its primary endpoint and demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit with a median OS of 15.0 months for patients treated with TEVIMBRA in combination with investigator’s choice of chemotherapy compared to 12.9 months for patients treated with placebo plus chemotherapy (n=997; HR: 0.80 [95% CI: 0.70, 0.92]; P=0.0011), resulting in a 20% reduction in the risk of death. In the PD-L1 ≥ 5% population, the median OS was 16.4 months for TEVIMBRA plus chemotherapy compared to 12.8 months for the placebo arm (HR: 0.71 [95% CI, 0.58-0.86]), which represents a 29% reduction in the risk of death.

The safety data in the applications included more than 2,800 patients who received TEVIMBRA as either monotherapy (1,534) or in combination with chemotherapy (1,319) at the approved dosing regimen. The most common Grade 3 or 4 adverse reactions (≥ 2%) for TEVIMBRA given in combination with chemotherapy were neutropenia, thrombocytopenia, anemia, fatigue, hypokalemia, hyponatremia, pneumonia, decreased appetite, rash, lymphopenia, alanine aminotransferase increased, aspartate aminotransferase increased, diarrhea, pneumonitis, and hepatitis.

TEVIMBRA is also approved in the EU for eligible patients with unresectable, locally advanced or metastatic ESCC after prior platinum-based chemotherapy and for three NSCLC indications covering both the first- and second-line settings.

The Company recently announced its intent to change its name to BeOne Medicines Ltd., reaffirming its commitment to develop innovative medicines to eliminate cancer by partnering with the global community to serve as many patients as possible.

About Gastric and Gastroesophageal Junction (G/GEJ) Adenocarcinoma

Gastric (stomach) cancer is the fifth most common cancer worldwide and the fifth highest leading cause of cancer mortality.¹ Nearly 1 million new patients were diagnosed with gastric cancer in 2022, and 660,000 deaths were reported globally. Gastroesophageal junction adenocarcinoma occurs at the area where the esophagus joins the stomach, which is just beneath the diaphragm (the thin sheet of breathing muscle under the lungs).²

About Esophageal Squamous Cell Carcinoma (ESCC)

Globally, esophageal cancer is the sixth most common cause of cancer-related deaths, and ESCC is the most common histologic subtype, accounting for nearly 90% of esophageal cancers. An estimated 957,000 new esophageal cancer cases are projected in 2040, an increase of nearly 60% from 2020, underscoring the need for additional effective treatments.³ Esophageal cancer is a rapidly fatal disease, and more than two-thirds of patients have advanced or metastatic disease at the time of diagnosis, with an expected five-year survival rate of less than 6% for those with distant metastases.⁴

About TEVIMBRA (Tislelizumab)

TEVIMBRA is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping the body’s immune cells detect and fight tumors.

TEVIMBRA is the foundational asset of BeiGene’s solid tumor portfolio and has shown potential across multiple tumor types and disease settings. The global TEVIMBRA clinical development program includes almost 14,000 patients enrolled to date in 34 counties and regions across 66 trials, including 20 registration-enabling studies. TEVIMBRA is approved in 42 countries, and more than 1.3 million patients have been treated globally.

Important Safety Information

The current European Summary of Product Characteristics (SmPC) for TEVIMBRA is available from the European Medicines Agency.

This information is intended for a global investor and media audience. Product indications vary by region.

About BeiGene

BeiGene, which plans to change its name to BeOne Medicines Ltd., is a global oncology company that is discovering and developing innovative 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 nearly 11,000 colleagues spans five continents. To learn more about BeiGene, please visit www.beigene.com and follow us on LinkedIn, X (formerly known as Twitter), Facebook and Instagram.

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 tislelizumab’s potential to deliver meaningful improvements in outcomes for eligible patients; BeiGene’s ability to provide rapid and broad access to TEVIMBRA to patients across Europe; 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.

To access BeiGene media resources, please visit our News & Media site.

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¹ Ferlay J, Ervik M, Lam F, Laversanne M, Colombet M, Mery L, Piñeros M, Znaor A, Soerjomataram I, Bray F (2020). Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer. Available from: https://gco.iarc.who.int/today. Accessed February 9, 2024.
² American Cancer Society. What Is Stomach Cancer? https://www.cancer.org/cancer/types/stomach-cancer/about/what-is-stomach-cancer.html.
³ Morgan E, et al. The Global Landscape of Esophageal Squamous Cell Carcinoma and Esophageal Adenocarcinoma Incidence and Mortality in 2020 and Projections to 2040: New Estimates From GLOBOCAN 2020. Gastroenterology. 2022 Sep;163(3):649-658.e2. doi: 10.1053/j.gastro.2022.05.054. Epub 2022 Jun 4. PMID: 35671803.
⁴ National Cancer Institute. Cancer stat facts: esophageal cancer. https://seer.cancer.gov/statfacts/html/esoph.html.

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Investor Contact:

Liza Heapes

+1 857-302-5663

ir@beigene.com

Media Contact:

Kim Bencker

+1 610-256-8932

media@beigene.com

Source: BeiGene, Ltd.

FAQ

What are the new approved indications for TEVIMBRA (BGNE) in Europe?

TEVIMBRA was approved for first-line treatment of advanced esophageal squamous cell carcinoma (ESCC) and gastric/gastroesophageal junction cancer in combination with chemotherapy.

What survival benefit did TEVIMBRA (BGNE) show in the RATIONALE-306 trial?

In the RATIONALE-306 trial, TEVIMBRA with chemotherapy showed median overall survival of 17.2 months versus 10.6 months for placebo plus chemotherapy, representing a 34% reduction in death risk.

What were the RATIONALE-305 trial results for TEVIMBRA (BGNE)?

The RATIONALE-305 trial showed median overall survival of 15.0 months for TEVIMBRA with chemotherapy versus 12.9 months for placebo plus chemotherapy, demonstrating a 20% reduction in death risk.