By Fineline Cube 
BeiGene, Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235), the China-based oncology specialist proposing to rename to BeOne Medicines Ltd., announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Tevimbra (tislelizumab) in combination with etoposide and platinum chemotherapy. This combination is proposed as a first-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC).
Drug Profile
Tislelizumab, an anti-PD-1 monoclonal antibody developed in-house by BeiGene, is already approved in the EU for various indications, including first-line treatment for unresectable esophageal squamous cell carcinoma (ESCC) and gastric or gastroesophageal junction (G/GEJ) adenocarcinoma in combination with chemotherapy. It is also approved for second-line treatment in advanced ESCC and three non-small cell lung cancer (NSCLC) indications.
Clinical Trial Results
The CHMP’s positive opinion is based on the Phase III RATIONALE-312 study (NCT04005716). In this study, tislelizumab combined with platinum and etoposide demonstrated a statistically and clinically significant improvement in overall survival (mOS: 15.5 months vs 13.5 months) compared to placebo plus chemotherapy, with no new safety signals identified.-Fineline Info & Tech