BeiGene Receives Positive CHMP Opinions for TEVIMBRA® as a First-Line Treatment for Advanced/Metastatic Gastric or Gastroesophageal Junction Cancer and Esophageal Squamous Cell Carcinoma
BeiGene announced positive CHMP opinions recommending extended authorization for TEVIMBRA® (tislelizumab) in two new indications:
1. First-line treatment of gastric or gastroesophageal junction (G/GEJ) adenocarcinoma in combination with chemotherapy for HER2-negative locally advanced unresectable or metastatic cancer with PD-L1 TAP score ≥ 5%.
2. First-line treatment of esophageal squamous cell carcinoma (ESCC) in combination with chemotherapy for unresectable, locally advanced or metastatic cancer with PD-L1 TAP score ≥ 5%.
These recommendations are based on positive results from the RATIONALE-305 and RATIONALE-306 Phase 3 trials, which demonstrated significant overall survival benefits for TEVIMBRA in combination with chemotherapy compared to placebo plus chemotherapy in both indications.
BeiGene ha annunciato pareri positivi dal CHMP che raccomandano l'estensione dell'autorizzazione per TEVIMBRA® (tislelizumab) in due nuove indicazioni:
1. Trattamento di prima linea dell'adenocarcinoma gastrico o della giunzione gastroesofagea (G/GEJ) in combinazione con chemioterapia per il cancro localmente avanzato non resecabile o metastatico HER2-negativo con punteggio PD-L1 TAP ≥ 5%.
2. Trattamento di prima linea del carcinoma a cellule squamose esofagee (ESCC) in combinazione con chemioterapia per il cancro non resecabile, localmente avanzato o metastatico con punteggio PD-L1 TAP ≥ 5%.
Queste raccomandazioni si basano su risultati positivi degli studi di Fase 3 RATIONALE-305 e RATIONALE-306, che hanno dimostrato importanti benefici in termini di sopravvivenza complessiva per TEVIMBRA in combinazione con chemioterapia rispetto al placebo più chemioterapia in entrambe le indicazioni.
BeiGene anunció opiniones positivas del CHMP recomendando la autorización extendida para TEVIMBRA® (tislelizumab) en dos nuevas indicaciones:
1. Tratamiento de primera línea del adenocarcinoma gástrico o de la unión gastroesofágica (G/GEJ) en combinación con quimioterapia para cáncer HER2-negativo localmente avanzado no resecable o metastásico con un puntaje PD-L1 TAP ≥ 5%.
2. Tratamiento de primera línea del carcinoma de células escamosas esofágicas (ESCC) en combinación con quimioterapia para cáncer no resecable, localmente avanzado o metastásico con un puntaje PD-L1 TAP ≥ 5%.
Estas recomendaciones se basan en resultados positivos de los ensayos de Fase 3 RATIONALE-305 y RATIONALE-306, que demostraron beneficios significativos en la supervivencia general para TEVIMBRA en combinación con quimioterapia en comparación con placebo más quimioterapia en ambas indicaciones.
BeiGene은 TEVIMBRA® (tislelizumab)의 확대 승인을 권장하는 긍정적인 CHMP 의견을 발표했습니다. 이는 두 가지 새로운 적응증에 해당합니다:
1. 위 또는 위식도 접합부(G/GEJ) 선암의 1차 치료는 PD-L1 TAP 점수 ≥ 5%인 HER2 음성 국소 진행성 재수술 불가 또는 전이성 암에 대해 화학요법과 병행하여 시행됩니다.
2. 식도 편평세포암(ESCC)의 1차 치료는 PD-L1 TAP 점수 ≥ 5%인 재수술 불가 국소 진행성 또는 전이성 암에 대해 화학요법과 병행하여 시행됩니다.
이러한 권장 사항은 RATIONALE-305 및 RATIONALE-306 3상 시험의 긍정적인 결과를 기반으로 하며, 두 가지 적응증 모두에서 화학요법과 병행한 TEVIMBRA가 위약 대 화학요법에 비해 유의미한 전체 생존 이점을 보여주었습니다.
BeiGene a annoncé des avis positifs du CHMP recommandant l'autorisation élargie pour TEVIMBRA® (tislelizumab) dans deux nouvelles indications :
1. Traitement de première ligne de l'adénocarcinome gastrique ou de la jonction gastro-œsophagienne (G/GEJ) en combinaison avec une chimiothérapie pour le cancer HER2-négatif localement avancé, non résécable ou métastatique, avec un score PD-L1 TAP ≥ 5%.
2. Traitement de première ligne du carcinome à cellules squameuses de l'œsophage (ESCC) en combinaison avec une chimiothérapie pour le cancer non résécable, localement avancé ou métastatique, avec un score PD-L1 TAP ≥ 5%.
Ces recommandations sont basées sur des résultats positifs des études de phase 3 RATIONALE-305 et RATIONALE-306, qui ont démontré des bénéfices significatifs en termes de survie globale pour TEVIMBRA en combinaison avec la chimiothérapie par rapport au placebo plus chimiothérapie dans les deux indications.
BeiGene gab positive Empfehlungen des CHMP bekannt, die eine erweiterte Zulassung für TEVIMBRA® (tislelizumab) in zwei neuen Indikationen empfehlen:
1. Erstlinientherapie von magengastrico oder gastroösophagealen Übergangs-Adenokarzinom (G/GEJ) in Kombination mit Chemotherapie für HER2-negatives lokal fortgeschrittenes, nicht resektables oder metastasiertes Krebs mit einem PD-L1 TAP-Wert ≥ 5%.
2. Erstlinientherapie von ösophagealem Plattenepithelkarzinom (ESCC) in Kombination mit Chemotherapie für nicht resektablen, lokal fortgeschrittenen oder metastasierten Krebs mit einem PD-L1 TAP-Wert ≥ 5%.
Diese Empfehlungen basieren auf positiven Ergebnissen der Phase-3-Studien RATIONALE-305 und RATIONALE-306, die signifikante Vorteile für das Gesamtüberleben von TEVIMBRA in Kombination mit Chemotherapie im Vergleich zu Placebo plus Chemotherapie in beiden Indikationen gezeigt haben.
- TEVIMBRA showed a 20% reduction in the risk of death for G/GEJ cancer patients (median OS: 15.0 vs 12.9 months)
- In PD-L1 ≥ 5% G/GEJ cancer population, TEVIMBRA reduced risk of death by 29% (median OS: 16.4 vs 12.8 months)
- TEVIMBRA demonstrated a 34% reduction in the risk of death for ESCC patients (median OS: 17.2 vs 10.6 months)
- In PD-L1 ≥ 5% ESCC population, TEVIMBRA reduced risk of death by 38% (median OS: 19.1 vs 10.0 months)
- TEVIMBRA is already approved in the EU for second-line ESCC and three NSCLC indications
- Most common Grade 3 or 4 adverse reactions include neutropenia, thrombocytopenia, anemia, and fatigue
Insights
The CHMP's positive opinions for TEVIMBRA® in first-line treatment of advanced gastric/gastroesophageal junction (G/GEJ) cancer and esophageal squamous cell carcinoma (ESCC) represent a significant advancement in treating these aggressive cancers. The RATIONALE-305 and RATIONALE-306 trials demonstrated substantial survival benefits:
- G/GEJ cancer:
20% reduction in death risk overall,29% for PD-L1 ≥5% patients - ESCC:
34% reduction in death risk overall,38% for PD-L1 ≥5% patients
These results are particularly impactful given the historically poor prognosis for these cancers. The combination of TEVIMBRA with chemotherapy could become a new standard of care for eligible patients, potentially improving outcomes in areas of high unmet need. However, it's important to note that the benefit is primarily seen in patients with PD-L1 expression ≥
This regulatory advancement for TEVIMBRA® is likely to have a positive impact on BeiGene's (NASDAQ: BGNE) financial outlook. Key points to consider:
- Expanded market: Approval in first-line settings for G/GEJ and ESCC would significantly increase the eligible patient population.
- Revenue potential: Given the survival benefits shown, TEVIMBRA could capture substantial market share in these indications.
- Competitive positioning: This would strengthen BeiGene's oncology portfolio, particularly in Europe where TEVIMBRA is already approved for certain NSCLC indications.
However, investors should note that market penetration will depend on factors like pricing, reimbursement decisions and competition from established therapies. The requirement for PD-L1 testing may also impact adoption rates. Overall, this news suggests positive growth prospects for BeiGene in the expanding immuno-oncology market, potentially driving future revenue and stock performance.
Positive opinion for first-line treatment of gastric or gastroesophageal junction cancer based on results of RATIONALE-305 study demonstrating statistically significant overall survival benefit for TEVIMBRA in combination with platinum- and fluoropyrimidine-based chemotherapy
Positive opinion for first-line treatment of esophageal squamous cell carcinoma based on results of RATIONALE-306 study demonstrating statistically significant overall survival benefit for TEVIMBRA in combination with platinum-based chemotherapy
In G/GEJ adenocarcinoma, the CHMP positive opinion 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 G/GEJ cancer whose tumors express PD-L1 with a tumor area positivity (TAP) score ≥
“Survival rates in the advanced stages of gastric/gastroesophageal and esophageal cancers are among the lowest of all cancer types despite recent advances, and new treatment options are needed,” said Prof. Florian Lordick, Director and Professor of Oncology of the University Cancer Center
“TEVIMBRA is foundational for BeiGene’s solid tumor portfolio. In line with our commitment to help patients affected by cancer in
The extension of indication application for first-line G/GEJ cancer is 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
The extension of indication application for first-line ESCC is 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
The safety data in the applications included 1,534 patients who received TEVIMBRA monotherapy at the approved dosing regimen, and 1,319 patients with G/GEJ cancer, ESCC or NSCLC who received TEVIMBRA at the approved dosing regimen (200 mg every 3 weeks) in combination with various chemotherapies. The most common Grade 3 or 4 adverse reactions 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 approved in the EU for eligible patients with advanced or metastatic ESCC after prior platinum-based chemotherapy and for three non-small cell lung cancer (NSCLC) indications covering both the first- and second-line settings.
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 (EC) is the sixth most common cause of cancer-related deaths, and ESCC is the most common histologic subtype, accounting for nearly
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 to aid the body’s immune cells to detect and fight tumors.
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 audience. Product indications vary by region.
About BeiGene
BeiGene 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 more than 10,000 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 better outcomes for eligible patients; 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
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.
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:
Liza Heapes
+1 857-302-5663
ir@beigene.com
Media:
Kim Bencker
+1 610-256-8932
media@beigene.com
To access BeiGene media resources, please visit our News & Media site.
Source: BeiGene, Ltd.
FAQ
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