BeOne, a global oncology company, today announced that the European Commission has approved TEVIMBRA® (tislelizumab) in combination with gemcitabine and cisplatin for the first-line treatment of adult patients with metastatic or recurrent nasopharyngeal carcinoma (NPC) not suitable for curative surgery or radiotherapy.
Nasopharyngeal carcinoma is a rare form of cancer that develops in the nasopharynx, the upper part of the throat located behind the nose. Due to its deep anatomical location and subtle early symptoms, NPC is often diagnosed at advanced stages.
Groundbreaking Results from the RATIONALE-309 Study
The European approval is supported by findings from RATIONALE-309 (NCT03924986), a Phase 3, double-blind, placebo-controlled, multicenter study involving 263 previously untreated patients with metastatic or recurrent NPC. Participants received either:
- TEVIMBRA + gemcitabine + cisplatin, or
- Placebo + gemcitabine + cisplatin
At the first prespecified interim analysis, TEVIMBRA significantly improved progression-free survival (PFS) compared to the control group (HR 0.52 [95% CI: 0.38, 0.73]; p < 0.0001), representing a 48% reduction in the risk of disease progression or death. Median PFS was 9.2 months with TEVIMBRA versus 7.4 months with placebo.
An updated analysis with an additional 12 months of follow-up confirmed consistent outcomes and showed a clinically meaningful improvement in overall survival (OS):
- Median OS of 45.3 months with TEVIMBRA combination therapy
- 31.8 months in the placebo arm
Safety Profile
TEVIMBRA plus chemotherapy was generally well tolerated, with no new safety concerns identified. Safety data from over 3,900 patients who received TEVIMBRA (as monotherapy or in combination) showed that the most common Grade 3 or 4 adverse reactions (≥10%) were neutropenia, anemia, and thrombocytopenia.
TEVIMBRA’s Expanding EU Indications
TEVIMBRA is now approved in the EU for several indications, including:
- First-line treatment of gastric or gastroesophageal junction (G/GEJ) adenocarcinoma
- First-line and second-line treatment of unresectable or previously treated esophageal squamous cell carcinoma (ESCC)
- First-line treatment of extensive-stage small cell lung cancer (ES-SCLC)
- Multiple non-small cell lung cancer (NSCLC) settings
About Nasopharyngeal Carcinoma (NPC)
NPC is a type of head and neck cancer originating in the nasopharynx—the passage behind the nose and above the back of the throat. Histologically, NPC can be classified into subtypes: keratinizing squamous, non-keratinizing, and basaloid squamous carcinoma.
Globally, NPC remains rare but exhibits a distinct geographic distribution, with a higher prevalence in East and Southeast Asia. In 2020, there were an estimated 133,000 new cases and 80,000 deaths due to NPC worldwide. While the overall 5-year survival rate is approximately 63%, that figure drops to 49% for patients with advanced disease.
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 BeOne’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 46 countries, and more than 1.5 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 availability and approved indications vary by country. Please refer to local prescribing information for complete details.
About BeOne
BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.
