China-based biotech company BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has received a marketing approval from the European Commission (EC) for its programmed death-1 (PD-1) inhibitor, Tevimbra (tislelizumab). The drug is now approved for use in combination with chemotherapy for the first-line treatment of esophageal squamous cell carcinoma (ESCC) and gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.
Phase III RATIONALE 306 Study Supports Indication Extension
BeiGene’s filing for the extension of the indication in first-line ESCC was supported by the results of the Phase III RATIONALE 306 study, a randomized, placebo-controlled, double-blind, global Phase III trial. The study aimed to evaluate the efficacy and safety of Tevimbra in combination with chemotherapy as a first-line treatment for patients with unresectable, locally advanced recurrent, or metastatic ESCC. Out of 649 enrolled patients, the Tevimbra/chemotherapy combination achieved a median overall survival (OS) of 17.2 months compared to 10.6 months for the placebo plus chemotherapy group, representing a 34% reduction in the risk of death and meeting the primary endpoint.
Improved Survival Rates and Additional Indications
Furthermore, the three-year OS in the PD-L1 ≥ 5% population showed a substantial improvement in favor of the Tevimbra arm, with a median of 19.1 months versus 10.0 months for the placebo, demonstrating a 38% reduction in the risk of death. Tevimbra is also approved in the European Union (EU) for eligible patients with unresectable, locally advanced, or metastatic ESCC after prior platinum-based chemotherapy. Additionally, it covers three non-small cell lung cancer (NSCLC) indications, including both first- and second-line settings, expanding the drug’s potential impact on cancer treatment in the region.-Fineline Info & Tech
