Positive CHMP Opinion for Tevimbra (tislelizumab) as a first-line treatment for nasopharyngeal cancer – Beigene

BeiGene, Ltd announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMA issued a positive opinion recommending approval of Tevimbra (tislelizumab), in combination with gemcitabine and cisplatin, for the first-line treatment of adult patients with recurrent, not amenable to curative surgery or radiotherapy, or metastatic NPC.

The extension of indication for NPC is based on results from BeiGene’s RATIONALE-309 (NCT03924986), a randomized, double-blind, placebo-controlled, multicenter, Phase III study to evaluate the efficacy and safety of Tevimbra, in combination with gemcitabine plus cisplatin, as first-line treatment in adult patients with recurrent or metastatic NPC. At the time of the prespecified interim analysis, the study, which randomized 263 treatment-naïve patients, met its primary endpoint, significantly prolonging progression-free survival (PFS) in the intent-to-treat (ITT) population (HR 0.52 [95% CI:0.38, 0.73] p<0.0001). The median PFS in the Tevimbra with chemotherapy arm was 9.2 months compared to 7.4 months in the placebo with chemotherapy arm. An updated analysis showed consistent efficacy results with the interim analysis. The median overall survival (OS) was 45.3 months for Tevimbra plus chemotherapy versus 31.8 months for placebo plus chemotherapy. Tevimbra plus chemotherapy was generally well tolerated, with no new safety signals identified.

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 (≥ 2%) for TEVIMBRA given in combination with chemotherapy were neutropenia, anemia, thrombocytopenia, hyponatremia, hypokalemia, fatigue, pneumonia, lymphopenia, rash, decreased appetite, increased aspartate aminotransferase, and increased alanine aminotransferase.

Chemotherapy has been the standard treatment for metastatic NPC; however, distant metastasis continues to be a significant cause of treatment failure and death, making new treatment options essential,” said Prof. Lisa Licitra, Chief of Head and Neck Cancer Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. “Results from the RATIONALE-309 study support the robust clinical benefit of Tevimbra plus chemotherapy, which has the potential to significantly reduce the risk of disease progression or death for patients with recurrent or metastatic NPC.”

“This announcement marks a second positive CHMP opinion for Tevimbra in 2025, signifying the potential to expand into yet another disease area in the European Union and to support even more patients living with cancer,” said Mark Lanasa, Chief Medical Officer, Solid Tumors at BeiGene. “As the foundation of our solid tumor portfolio, we are encouraged by Tevimbra’s momentum in achieving more than 100 regulatory approvals for a range of cancer indications across the world, including major markets such as the US, the EU, China, and Japan, demonstrating the strength of evidence across a range of indications.”