By Fineline Cube 
The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the use of BeOne Medicines Ltd.’s (NASDAQ: ONC, HKG: 6160, SHA: 688235) Tevimbra (tislelizumab) in combination with gemcitabine and cisplatin for first-line treatment of adult patients with recurrent, non-curative, or metastatic nasopharyngeal cancer (NPC). This recommendation follows the positive opinion received from the EMA in April this year.
Clinical Trial Results
The recommendation is based on the Phase III RATIONALE-309 study, which involved 263 treatment-naïve patients. The trial demonstrated that Tevimbra significantly prolonged progression-free survival (PFS) in the intent-to-treat (ITT) population. The median PFS in the Tevimbra plus chemotherapy arm was 9.2 months compared to 7.4 months in the placebo plus chemotherapy arm (HR 0.52 [95% CI: 0.38, 0.73], p<0.0001). The median overall survival (OS) was 45.3 months for the Tevimbra/chemo combination versus 31.8 months for the placebo plus chemotherapy arm. Additionally, the Tevimbra/chemo combination was generally well tolerated, with no new safety signals identified.-Fineline Info & Tech