BeOne and Amgen announced on 16 July that China's National Medical Products Administration (NMPA) has accepted a new drug application (NDA) for tarlatamab, a first-in-class CD3/DLL3 bispecific antibody (BsAb) for extensive-stage small cell lung cancer (ES-SCLC) that entered priority review last week. The drug, which activates T-cells to target DLL3-expressing tumour cells, showed a 40% objective response rate (ORR) and 14.3-month median overall survival (mOS) in Phase II trials. Tarlatamab received US accelerated approval in May 2024 based on the DeLLphi-301 study and demonstrated a 5.3-month survival benefit over chemotherapy in Phase III DeLLphi-304 trials.

ES-SCLC accounts for 15% of global lung cancer cases, with limited treatment options post-chemotherapy failure. Tarlatamab's safety profile was favourable, with grade ≥3 adverse events at 27% versus 62% for chemotherapy. BeOne is leading China-focused trials while collaborating with Amgen on global development.

According to PharmCube's NextBiopharm® database, tarlatamab is the only CD3/DLL3 BsAb approved globally within a total 25 active projects. Click here to request a free trial for NextBiopharm®.