BeiGene Receives Positive CHMP Opinion for TEVIMBRA® as a First-Line Treatment for Extensive-Stage Small Cell Lung Cancer
BeiGene (NASDAQ: ONC) received a positive CHMP opinion recommending approval of TEVIMBRA® (tislelizumab) in combination with etoposide and platinum chemotherapy for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC).
The recommendation is based on the RATIONALE-312 Phase 3 study results, which demonstrated significant survival benefits. The study of 457 patients showed median overall survival of 15.5 months for TEVIMBRA with chemotherapy versus 13.5 months for placebo plus chemotherapy, representing a 25% reduction in death risk (HR 0.75).
TEVIMBRA is already approved in the EU for multiple indications including esophageal squamous cell carcinoma (ESCC), gastric/gastroesophageal junction adenocarcinoma, and non-small lung cancer. The drug has received 58 regulatory approvals in 18 months and is being studied in combination with other molecules.
BeiGene (NASDAQ: ONC) ha ricevuto un parere positivo dal CHMP che raccomanda l'approvazione di TEVIMBRA® (tislelizumab) in combinazione con etoposide e chemioterapia a base di platino per il trattamento di prima linea del cancro polmonare a piccole cellule in stadio avanzato (ES-SCLC).
La raccomandazione si basa sui risultati dello studio di fase 3 RATIONALE-312, che ha dimostrato significativi benefici in termini di sopravvivenza. Lo studio, condotto su 457 pazienti, ha mostrato una sopravvivenza complessiva mediana di 15,5 mesi per TEVIMBRA con chemioterapia rispetto a 13,5 mesi per placebo più chemioterapia, rappresentando una riduzione del 25% del rischio di morte (HR 0,75).
TEVIMBRA è già approvato nell'UE per molteplici indicazioni, tra cui carcinoma squamoso esofageo (ESCC), adenocarcinoma gastrico/giunzione gastroesofagea e carcinoma polmonare non a piccole cellule. Il farmaco ha ricevuto 58 approvazioni regolatorie in 18 mesi ed è attualmente studiato in combinazione con altre molecole.
BeiGene (NASDAQ: ONC) recibió una opinión positiva del CHMP recomendando la aprobación de TEVIMBRA® (tislelizumab) en combinación con etopósido y quimioterapia con platino para el tratamiento de primera línea del cáncer de pulmón de células pequeñas en estadio avanzado (ES-SCLC).
La recomendación se basa en los resultados del estudio de fase 3 RATIONALE-312, que demostró beneficios significativos en la supervivencia. El estudio, que incluyó a 457 pacientes, mostró una supervivencia global mediana de 15,5 meses para TEVIMBRA con quimioterapia frente a 13,5 meses para placebo más quimioterapia, lo que representa una reducción del 25% en el riesgo de muerte (HR 0,75).
TEVIMBRA ya está aprobado en la UE para múltiples indicaciones, incluyendo carcinoma esofágico de células escamosas (ESCC), adenocarcinoma gástrico/junción gastroesofágica y cáncer de pulmón no microcítico. El fármaco ha recibido 58 aprobaciones regulatorias en 18 meses y se está estudiando en combinación con otras moléculas.
BeiGene (NASDAQ: ONC)는 광범위한 단계의 소세포 폐암(ES-SCLC)에 대한 1차 치료로 에토포시드 및 백금 화학요법과 함께 TEVIMBRA® (티슬리주맙)의 승인을 권장하는 긍정적인 CHMP 의견을 받았습니다.
이 권장은 RATIONALE-312 3상 연구 결과를 기반으로 하며, 이는 중대한 생존 이점을 입증했습니다. 457명의 환자를 대상으로 한 연구에서 TEVIMBRA와 화학요법의 중앙 전체 생존 기간은 15.5개월로, 위약과 화학요법의 13.5개월에 비해 25%의 사망 위험 감소를 나타냈습니다 (HR 0.75).
TEVIMBRA는 이미 식도 편평세포 암종(ESCC), 위/식도 접합부 선암, 비소세포 폐암을 포함한 여러 적응증에 대해 EU에서 승인되었습니다. 이 약물은 18개월 동안 58개의 규제 승인을 받았으며, 다른 분자와의 병용 연구가 진행 중입니다.
BeiGene (NASDAQ: ONC) a reçu un avis positif du CHMP recommandant l'approbation de TEVIMBRA® (tislelizumab) en combinaison avec l'étoposide et une chimiothérapie à base de platine pour le traitement de première ligne du cancer du poumon à petites cellules à un stade avancé (ES-SCLC).
Cette recommandation est basée sur les résultats de l'étude de phase 3 RATIONALE-312, qui a démontré des avantages significatifs en matière de survie. L'étude, portant sur 457 patients, a montré une survie globale médiane de 15,5 mois pour TEVIMBRA avec chimiothérapie contre 13,5 mois pour le placebo associé à la chimiothérapie, représentant une réduction de 25 % du risque de décès (HR 0,75).
TEVIMBRA est déjà approuvé dans l'UE pour plusieurs indications, y compris le carcinome épidermoïde de l'œsophage (ESCC), l'adénocarcinome gastrique/jonction gastro-œsophagienne et le cancer du poumon non à petites cellules. Le médicament a obtenu 58 approbations réglementaires en 18 mois et est en cours d'étude en combinaison avec d'autres molécules.
BeiGene (NASDAQ: ONC) erhielt eine positive CHMP-Empfehlung zur Genehmigung von TEVIMBRA® (tislelizumab) in Kombination mit Etoposid und Platin-Chemotherapie für die Erstlinientherapie von ausgedehntem kleinzelligem Lungenkrebs (ES-SCLC).
Die Empfehlung basiert auf den Ergebnissen der RATIONALE-312 Phase-3-Studie, die signifikante Überlebensvorteile zeigte. Die Studie mit 457 Patienten ergab eine mediane Gesamtüberlebenszeit von 15,5 Monaten für TEVIMBRA mit Chemotherapie im Vergleich zu 13,5 Monaten für Placebo plus Chemotherapie, was eine 25%ige Risikominderung für den Tod darstellt (HR 0,75).
TEVIMBRA ist bereits in der EU für mehrere Indikationen zugelassen, darunter das Plattenepithelkarzinom der Speiseröhre (ESCC), das adenokarzinom des Magens/der gastroösophagealen Übergangs und das nicht-kleinzellige Lungenkarzinom. Das Medikament hat in 18 Monaten 58 Zulassungen erhalten und wird in Kombination mit anderen Molekülen untersucht.
- Positive CHMP opinion recommending approval for new ES-SCLC indication
- Significant 25% reduction in death risk demonstrated in Phase 3 trial
- 2-month survival benefit over placebo (15.5 vs 13.5 months)
- Strong regulatory momentum with 58 approvals in 18 months
- Multiple existing EU approvals across different cancer types
- Notable adverse reactions including severe neutropenia, anemia, and thrombocytopenia
Insights
The CHMP positive opinion for TEVIMBRA in extensive-stage small cell lung cancer represents a meaningful advancement for a challenging cancer with treatment options. The RATIONALE-312 study demonstrated a
While a 2-month survival improvement may seem modest, it's clinically significant in ES-SCLC, where prognosis is typically poor and disease progression rapid. The favorable safety profile, with no new signals identified when combined with platinum-etoposide chemotherapy, is particularly important for maintaining quality of life during treatment.
TEVIMBRA would join a small group of immunotherapy options for first-line ES-SCLC treatment in Europe. The data's statistical significance (HR 0.75, p=0.0040) provides robust evidence supporting clinical benefit. For European oncologists, this offers another valuable option in a therapeutic area where innovations have been and outcomes historically poor.
This positive CHMP recommendation significantly strengthens BeiGene's solid tumor portfolio by potentially expanding TEVIMBRA to a fourth indication in Europe. ES-SCLC represents an additional market opportunity with substantial unmet needs and few effective therapies.
The regulatory momentum for TEVIMBRA is impressive, with 58 approvals across multiple markets in just 18 months. This demonstrates BeiGene's execution capabilities in navigating complex regulatory pathways globally. While European Commission final approval is still pending, positive CHMP opinions typically lead to formal authorization within 2-3 months.
Beyond this immediate opportunity, BeiGene's strategy of investigating TEVIMBRA in combination with novel molecules suggests a pipeline-in-a-product approach that could yield additional indications. This positions TEVIMBRA as a cornerstone asset with expanding utility across multiple cancer types.
The planned corporate rebranding to BeOne Medicines signals a strategic evolution beyond the company's Chinese roots toward a truly global oncology player, potentially broadening its investor appeal and market positioning.
Positive opinion for first-line treatment of extensive-stage small cell lung cancer based on results of RATIONALE-312 study demonstrating statistically significant overall survival benefit for TEVIMBRA in combination with chemotherapy
“The aggressive nature of extensive-stage small cell lung cancer makes it an extremely difficult type of lung cancer to treat, and currently available treatments may not adequately control disease progression,” said Prof. Silvia Novello, M.D., Ph.D., President Women Against Lung Cancer in
The extension of indication for ES-SCLC is based on results from BeiGene’s RATIONALE-312 (NCT04005716), a randomized, double-blind, placebo-controlled, multicenter, Phase 3 study to evaluate the efficacy and safety of TEVIMBRA, in combination with platinum (investigator’s choice of cisplatin or carboplatin) plus etoposide, as first-line treatment in adult patients with ES-SCLC. The study, which randomized 457 patients, met its primary endpoint, exhibiting a statistically significant and clinically meaningful improvement in overall survival (OS) with TEVIMBRA in combination with chemotherapy, compared with placebo plus chemotherapy in the intent-to-treat (ITT) population. As reported in the Journal of Thoracic Oncology, at the protocol-defined final analysis, the median OS was 15.5 months for TEVIMBRA with chemotherapy versus 13.5 months for placebo plus chemotherapy (HR 0.75 [
“Today's positive CHMP opinion marks another important step for TEVIMBRA to potentially expand its indications in a fourth disease area in
The pooled safety data in this extension of indication included more than 3,900 patients who received TEVIMBRA as either monotherapy (n=1,952) or in combination with chemotherapy (n=1,950) at the approved dosing regimen. The most common Grade 3 or 4 adverse reactions (≥
TEVIMBRA is currently approved in the EU as a first-line treatment for eligible patients with unresectable esophageal squamous cell carcinoma (ESCC) and gastric or gastroesophageal junction (G/GEJ) adenocarcinoma in combination with chemotherapy, as a second line treatment in unresectable, locally advanced or metastatic ESCC after prior platinum-based chemotherapy, and for three non-small lung cancer (NSCLC) indications covering both the first- and second-line settings.
The Company recently announced its intent to change its name to BeOne Medicines, reaffirming its commitment to develop innovative medicines to eliminate cancer by partnering with the global community to serve as many patients as possible.
About Extensive-Stage Small Cell Lung Cancer (ES-SCLC)
Lung cancer is the leading cause of cancer-related deaths worldwide.1 SCLC is an aggressive, high-grade cancer that accounts for
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.
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 35 countries and regions across 70 trials, including 21 registration-enabling studies. TEVIMBRA is approved in 45 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 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 more than 11,000 colleagues spans six continents. To learn more about BeiGene, please visit www.beigene.com.
Forward-Looking Statement
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 ability of TEVIMBRA plus chemotherapy to extend overall survival for patients with ES-SCLC; the ability of TEVIMBRA to further expand its indications and reach more patients affected by cancer; TEVIMBRA’s ability to herald the next wave of cancer therapeutics; 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 annual report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the
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1 Sung H, Ferlay J, Siegel RL et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J. Clin. 71(3), 209–249 (2021).
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Investor Contact
Liza Heapes
+1 857-302-5663
ir@beigene.com
Media Contact
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+1 610-256-8932
media@beigene.com
Source: BeiGene, Ltd.
FAQ
What were the key survival benefits shown in TEVIMBRA's RATIONALE-312 trial for ES-SCLC?
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