BeiGene’s Biologics License Application for tevimbra accepted by FDA

BeiGene announced that the FDA has accepted a Biologics License Application – BLA – for tevimbra, in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. The FDA’s action date on the BLA is expected in December 2024. The filing is based on results from the global RATIONALE-305 trial. The study met its primary endpoint of overall survival of 15.0 months for patients treated with tevimbra in combination with investigator’s choice of chemotherapy vs.12.9 months for patients treated with placebo plus chemotherapy, demonstrating a 20% reduction in the risk of death. Additionally, tevimbra plus chemotherapy was associated with a higher objective response rate and median duration of response vs. placebo plus chemotherapy. The safety profile for tevimbra in combination with chemotherapy was manageable and in line with the known safety profile of anti-PD-1 antibodies. Tevimbra was recently approved by the European Commission for the treatment of patients with advanced or metastatic esophageal squamous cell carcinoma after prior chemotherapy. The FDA is also reviewing a BLA for tevimbra as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC with a target action date in July 2024.