FDA approves Amgen T-cell engager for small cell lung cancer

May 17, 2024

The FDA has approved Amgen’s Imdelltra, a T-cell engager therapy for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have experienced disease progression after platinum-based chemotherapy. This marks the first FDA-approved therapy targeting DLL3 in ES-SCLC.

The approval was granted under the FDA's accelerated approval pathway, and continued approval will depend on further verification of clinical benefits in additional trials.

Imdelltra's approval is based on results from the phase 2 DeLLphi-301 clinical trial, which reported a 40% objective response rate, a median duration of response of 9.7 months, and a median overall survival of 14.3 months among patients. The drug works by targeting DLL3, a protein expressed on the surface of SCLC cells, and activating T-cells to attack these tumor cells.

Several drugmakers are currently developing DLL3-targeting therapies for cancer treatment as well; Boehringer Ingelheim is working on BI 764532, a DLL3-targeting T-cell engager for treating small cell lung cancer and other neuroendocrine carcinomas, currently in phase 2 trials. Molecular Partners, in collaboration with Orano Med, is also developing DLL3-targeting therapies, leveraging the protein's expression in tumor cells for selective treatment. Additionally, Zai Lab is investigating ZL-1310, an antibody-drug conjugate targeting DLL3 for solid tumors​.