Tarlatamab, a CD3/DLL3 bispecific antibody (BsAb) co-developed by Amgen and BeOne, demonstrated a 39% objective response rate (ORR) in the Phase II DeLLphi-307 trial for third-line extensive-stage small cell lung cancer (ES-SCLC) in China. Among 31 evaluable patients, the disease control rate (DCR) was 61.3%, with median progression-free survival (mPFS) of 2.9 months and overall survival (OS) not yet reached. The drug's safety profile aligned with global data, showing cytokine release syndrome in 87% of cases (mostly grade 1 to 2) and no treatment discontinuations.

The BsAb, approved in the US in 2024 for ES-SCLC, activates T-cells against DLL3-expressing tumour cells, a target present in 85% to 96% of SCLC cases. BeOne has submitted a New Drug Application (NDA) with China's National Medical Products Administration (NMPA) based on these results, offering potential for improved outcomes in a disease where median survival post-relapse remains 8 to 10 months. The data were presented at the 2025 World Conference on Lung Cancer in Spain.

According to PharmCube's NextBiopharm® database, tarlatamab is being developed in a dozen indications. Click here to request a free trial for NextBiopharm®.