BeiGene Gets CHMP Approval for TEVIMBRA as Initial Nasopharyngeal Cancer Therapy

SAN CARLOS, Calif.-- BeiGene, Ltd., a prominent global oncology company soon to be known as BeOne Medicines Ltd., has announced a significant development for its cancer treatment drug, TEVIMBRA® (tislelizumab). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive recommendation for the approval of TEVIMBRA in combination with gemcitabine and cisplatin. This recommendation targets the first-line treatment of adult patients with nasopharyngeal cancer (NPC) that has recurred, cannot be treated with surgery or radiotherapy, or has metastasized.

Traditionally, chemotherapy has been the go-to treatment for metastatic NPC; however, the persistence of distant metastasis remains a major challenge leading to treatment failures and fatalities. As such, the introduction of novel treatment options is crucial. According to Prof. Lisa Licitra from the Fondazione IRCCS Istituto Nazionale dei Tumori in Milan, the combination of TEVIMBRA with chemotherapy has demonstrated a robust clinical benefit. The therapy has shown potential in significantly reducing the risk of disease progression or death among patients with recurrent or metastatic NPC.

The recommendation for expanding TEVIMBRA's use for NPC comes on the back of positive results from BeiGene's RATIONALE-309 study. This Phase 3 trial was designed to evaluate the efficacy and safety of TEVIMBRA in combination with gemcitabine plus cisplatin in adult patients with recurrent or metastatic NPC. In the study, which involved 263 treatment-naïve patients, TEVIMBRA met its primary endpoint, showing a significant extension in progression-free survival (PFS) compared to the placebo group. Specifically, the median PFS for patients receiving TEVIMBRA with chemotherapy was 9.2 months, compared to 7.4 months for those on placebo with chemotherapy. In terms of overall survival (OS), the median duration was 45.3 months for the TEVIMBRA group versus 31.8 months for the placebo group. Additionally, the treatment's safety profile was deemed acceptable, with no new adverse safety signals identified.

According to Dr. Mark Lanasa, Chief Medical Officer for Solid Tumors at BeiGene, the CHMP's opinion marks the second favorable recommendation for TEVIMBRA in 2025. This progress points to a potential expansion into new therapeutic areas within the European Union, thereby aiding more cancer patients. TEVIMBRA plays a vital role in BeiGene's solid tumor treatment portfolio and has achieved more than 100 regulatory approvals worldwide, including in major markets like the US, EU, China, and Japan. These approvals underscore the strong evidence supporting TEVIMBRA across various cancer types.

The safety data for this indication extension included over 3,900 patients treated with TEVIMBRA, either alone or in combination with chemotherapy. Common Grade 3 or 4 adverse effects (≥ 2%) for the combination therapy included neutropenia, anemia, and thrombocytopenia, among others. Currently, TEVIMBRA is approved in the EU for multiple indications, such as first-line treatment of gastric or gastroesophageal junction adenocarcinoma, and esophageal squamous cell carcinoma, among others.

Nasopharyngeal cancer (NPC) is a type of head and neck cancer that originates in the nasopharynx, the upper throat passage connecting the nose to the lungs. Due to its anatomical position and mild early symptoms, NPC is often diagnosed at advanced stages, complicating early detection. Globally, NPC presents around 133,000 new cases and causes approximately 80,000 deaths annually, with a notable prevalence in Asia. The overall five-year survival rate is around 63%, but this figure drops to 49% for advanced cases.

TEVIMBRA (Tislelizumab) is a humanized immunoglobulin G4 (IgG4) monoclonal antibody specifically designed to target the programmed cell death protein 1 (PD-1). Its unique design minimizes binding to Fc-gamma receptors on macrophages, enhancing the recognition and destruction of tumors by the body's immune cells. TEVIMBRA is central to BeiGene’s strategy for treating solid tumors and has shown potential across various cancer types. Its clinical development program spans nearly 14,000 patients in 70 trials across 35 countries, with approvals in 46 countries, treating over 1.5 million patients globally.

BeiGene, which will soon rebrand as BeOne Medicines Ltd., is committed to discovering and developing innovative, affordable cancer treatments. The company boasts a diverse therapeutic pipeline and aims to significantly improve access to essential medicines for cancer patients worldwide. With a growing team of over 11,000 employees across six continents, BeiGene is dedicated to expanding its impact in the oncology field.