Amgen's DLL3/CD3 Bispecific Antibody Tarlatamab Demonstrates Significant Overall Survival Benefit in Phase III Trial

▎Armstrong

On April 11, 2025, Amgen announced that the DLL3/CD3 bispecific antibody reached the primary endpoint of OS in a Phase III clinical trial, significantly extending mOS compared to the chemotherapy control group.

Amgen to Present Detailed Data from DeLLphi-304 at Upcoming Medical Conference

In May 2024, Tarlatamab received FDA accelerated approval based on the phase II clinical DeLLphi-301 data, with an ORR of 40% in 99 patients, including a CR of 2% and an mDoR of 9.7 months.

Tarlatamab was developed on Amgen's HLE-BiTE technology platform and is also the first CD3 bispecific antibody to achieve a breakthrough in common solid tumors.

Summary

For a long time, the successful application of CAR-T cell therapy and CD3 bispecific antibodies has been limited to hematological tumors, but this situation is rapidly changing. CAR-T is still in progress, TIL has been approved for the treatment of melanoma, and DLL3/CD3 bispecific antibody has been approved for the treatment of small cell lung cancer and succeeded in confirmatory phase III clinical trials.At the same time, autoimmune diseases are also rapidly becoming another popular track for fierce competition in CAR-T and other cell therapies, as well as CD3 bispecific antibodies.