European Commission Approves TEVIMBRA® (Tislelizumab) with Chemotherapy as First-Line Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma
BeOne Medicines Ltd., a global biotechnology company dedicated to oncology innovation, today announced that the European Commission (EC) has granted marketing authorization for TEVIMBRA® (tislelizumab) in combination with chemotherapy for the treatment of adult patients with metastatic or recurrent nasopharyngeal carcinoma (NPC) that is not amenable to curative surgery or radiotherapy. This approval marks a significant milestone in the management of this rare cancer and represents a critical therapeutic advance for patients facing limited treatment options.
Nasopharyngeal carcinoma is a rare and aggressive malignancy arising in the nasopharynx—the upper part of the throat located behind the nose and near the base of the skull. This type of cancer is often diagnosed at an advanced stage, as early symptoms are generally non-specific or mild, such as nasal congestion, nosebleeds, or ear dysfunction. Its anatomic location and asymptomatic progression make early detection difficult, which complicates treatment and significantly affects patient prognosis.
Groundbreaking Approval Based on RATIONALE-309 Study
The European Commission’s decision is supported by results from the RATIONALE-309 clinical trial (NCT03924986), a large-scale, multicenter, randomized, double-blind, placebo-controlled Phase 3 study designed to evaluate the efficacy and safety of TEVIMBRA in combination with gemcitabine and cisplatin, a standard chemotherapy backbone, in treatment-naïve patients with recurrent or metastatic NPC.
A total of 263 patients were enrolled and randomly assigned to receive either the TEVIMBRA combination regimen or placebo plus chemotherapy. The study met its primary endpoint at the first pre-specified interim analysis, demonstrating a statistically significant improvement in progression-free survival (PFS). Specifically, patients in the TEVIMBRA arm achieved a 48% reduction in the risk of disease progression or death compared to those receiving placebo (Hazard Ratio [HR]: 0.52; 95% CI: 0.38–0.73; p<0.0001). The median PFS was 9.2 months in the TEVIMBRA group versus 7.4 months in the control group.
An updated analysis conducted with an additional 12 months of follow-up reinforced the initial findings. Importantly, the trial also demonstrated a clinically meaningful and sustained improvement in overall survival (OS). Patients treated with TEVIMBRA in combination with chemotherapy experienced a median OS of 45.3 months, compared to 31.8 months for those in the placebo arm—a substantial survival advantage of over 13 months.
These results establish TEVIMBRA plus chemotherapy as a new first-line standard of care for advanced NPC in the EU, providing oncologists with a novel immuno-oncology-based therapeutic strategy that meaningfully extends both survival and disease control.
Expert Perspectives on Clinical Impact
Professor Lisa Licitra, Chief of the Head and Neck Cancer Medical Oncology Department at Fondazione IRCCS Istituto Nazionale dei Tumori in Milan, Italy, welcomed the approval, calling it a major advance for NPC care in Europe.
The approval of TEVIMBRA combined with chemotherapy in Europe marks an important advancement for people with recurrent or metastatic nasopharyngeal carcinoma—a rare and challenging disease,” Prof. Licitra stated. “Thanks to the compelling results from the RATIONALE-309 study, we now have a powerful new treatment that not only delays disease progression but also helps patients live longer. This approval brings new hope and a clinically proven option to patients who urgently need better care.
Favorable Safety Profile
TEVIMBRA in combination with chemotherapy was generally well tolerated, with no new safety signals identified during the study or in pooled safety data. Over 3,900 patients have been treated with TEVIMBRA across multiple trials—either as 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 observed in patients treated with the TEVIMBRA combination were neutropenia, anemia, and thrombocytopenia, aligning with expectations from cytotoxic chemotherapy regimens. These findings affirm the regimen’s acceptable safety profile, especially in light of its substantial survival benefit.
Broadening TEVIMBRA’s EU Footprint
This approval in NPC adds to TEVIMBRA’s growing oncology portfolio in the European Union, where the product has already received approvals for multiple solid tumor indications. These include:
- First-line treatment for gastric or gastroesophageal junction (G/GEJ) adenocarcinoma
- First-line and second-line treatment for unresectable or metastatic esophageal squamous cell carcinoma (ESCC)
- First-line treatment for extensive-stage small cell lung cancer (ES-SCLC)
- Three indications for non-small cell lung cancer (NSCLC) in both the first- and second-line settings
With this latest addition, TEVIMBRA now holds a comprehensive EU label across lung, gastrointestinal, and head and neck cancers, reinforcing its position as a key immunotherapy option in Europe.
Dr. Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeOne, emphasized the company’s commitment to broadening patient access to TEVIMBRA globally:
Following our recent EU approval of TEVIMBRA for extensive-stage small cell lung cancer, this new authorization in nasopharyngeal carcinoma reflects strong momentum in broadening access to our immunotherapy across solid tumors,” said Dr. Lanasa. “With a comprehensive EU label spanning lung and gastrointestinal cancers, and more than 100 regulatory approvals globally, we are delivering on our ambition to bring innovative therapies to more patients around the world.
Understanding Nasopharyngeal Carcinoma (NPC)
NPC is a distinct subset of head and neck cancer, biologically and epidemiologically different from other squamous cell carcinomas of the head and neck. It originates in the epithelial cells lining the nasopharynx and can be classified into three main histological subtypes: keratinizing squamous cell carcinoma, non-keratinizing carcinoma (differentiated or undifferentiated), and basaloid squamous cell carcinoma.
NPC is associated with Epstein-Barr Virus (EBV) infection, especially in endemic regions such as Southeast Asia, North Africa, and parts of the Middle East. Globally, NPC is considered rare, accounting for an estimated 133,000 new cases and 80,000 deaths annually as of 2020. However, in high-incidence areas, it remains one of the most common cancers.
The 5-year survival rate for NPC depends heavily on the stage at diagnosis. While localized disease has a relatively favorable outlook, the prognosis worsens significantly for patients with recurrent or metastatic disease. The overall 5-year survival rate for all NPC cases is approximately 63%, but it falls to 49% in advanced stages.
A Global Push for Better Access
With more than 100 regulatory approvals worldwide, TEVIMBRA is at the forefront of BeOne Medicines’ mission to provide innovative, accessible, and affordable cancer treatments globally. The addition of this NPC indication represents a meaningful step toward addressing unmet medical needs in rare cancers and strengthening the company’s global oncology footprint.
As BeOne continues to advance its immunotherapy pipeline, the company is also exploring additional indications for TEVIMBRA across other tumor types, reflecting its long-term commitment to expanding the role of PD-1 inhibition in cancer treatment.
