China's Center for Drug Evaluation (CDE) granted priority review on 8 July to tarlatamab, a CD3/DLL3 bispecific antibody (BsAb) co-developed by BeOne and Amgen for extensive-stage small cell lung cancer (ES-SCLC). The drug redirects T-cells to kill DLL3-expressing tumour cells, with 85% to 96% of SCLC patients showing DLL3 expression.

Tarlatamab received accelerated approval from US regulator the Food and Drug Administration (FDA) in May 2024 based on Phase II DeLLphi-301 data (40% objective response rate, 9.7-month median duration of response). The current application leverages Phase II DeLLphi-307 results in Chinese patients. A global Phase III trial (DeLLphi-304) recently met its primary endpoint, demonstrating statistically significant overall survival benefit over standard chemotherapy. BeOne plans to submit a new drug application (NDA) in China this year.