By Fineline Cube 
China-based BeOne Medicines Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235) announced that its PD-1 antibody Tislelizumab (brand name: Baizean) has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). The CHMP recommended approval for Tislelizumab in combination with platinum-containing chemotherapy as neoadjuvant treatment for adult patients with resectable, high-risk non-small cell lung cancer (NSCLC), followed by continued single-agent adjuvant therapy post-surgery.
Clinical Trial Results
The recommendation is based on the Phase III RATIONALE-315 study, which demonstrated a major pathological response (MPR) rate of 56.2% in the Tislelizumab group compared to 15.0% in the control group. The pathological complete response (pCR) rates were 40.7% and 5.7%, respectively. Additionally, event-free survival (EFS) and overall survival (OS) showed statistically significant benefits. The safety profile was consistent with previous findings, with no new safety signals identified and a 72.1% incidence of treatment-related Grade 3 or higher adverse events.
Regulatory and Market Impact
If approved, Tislelizumab will become the first domestically developed PD-1 drug in the EU for perioperative NSCLC treatment, further expanding its indications in lung cancer. Tislelizumab is already approved in the EU for multiple lung and gastrointestinal cancer indications and is marketed in over 46 countries and regions globally. This CHMP opinion sets the stage for formal approval by the European Commission.-Fineline Info & Tech