By Fineline Cube 
China-based BeOne Medicines Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235) announced that it has received marketing approval from the European Commission for its drug Tevimbra (tislelizumab) in combination with gemcitabine and cisplatin. The approval is for the first-line treatment of adult patients with metastatic or recurrent nasopharyngeal carcinoma (NPC) who are ineligible for curative surgery or radiotherapy.
Tevimbra: A Humanized Anti-PD-1 Monoclonal Antibody
Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody with unique structural modifications. Currently approved in 46 countries and regions worldwide, it has benefited over 1.5 million patients. The European Commission’s approval is based on results from the RATIONALE-309 study, which met its primary endpoint at a pre-specified interim analysis.
Clinical Trial Results
In the RATIONALE-309 trial, tislelizumab significantly prolonged progression-free survival (PFS) in the intent-to-treat (ITT) population (HR 0.52; 95% CI: 0.38–0.73; p<0.0001), alongside a 48% reduction in the risk of progression or death. The median PFS was 9.2 months in the tislelizumab/chemotherapy combination group, compared to 7.4 months in the placebo plus chemotherapy group. An additional 12-month follow-up update analysis showed that the effectiveness results were consistent with the mid-term analysis results. The overall survival (OS) achieved clinically significant sustained improvement (median OS: 45.3 months vs. 31.8 months). The overall tolerability of the tislelizumab/chemotherapy combination was good, with no new safety signals observed.-Fineline Info & Tech