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Trial result
Neuroendocrine and adrenal tumors

Obrixtamig (DLL3/CD3 Engager) Achieves 40% ORR in DLL3-High Extrapulmonary NEC

Trial ID
NCT04429087 on ClinicalTrials.gov
Cancer type
Neuroendocrine Tumor
Published in
New in Oncology - May 29, 2025

Delta-like ligand 3 (DLL3) is highly expressed in neuroendocrine carcinomas (NEC). Obrixtamig (BI 764532) is a DLL3/CD3 IgG-like T-cell engager that targets DLL3-positive tumors. In a Phase I trial (NCT04429087), obrixtamig yielded a 40.0% ORR (95% CI: 24.6–57.7) and a median DoR of 7.9 months in DLL3-high epNEC patients versus a 3.3% ORR in DLL3-low cases; safety was manageable with Grade ≥3 TRAEs in 23.3% (DLL3-high) and 20.0% (DLL3-low).

Take home

In this first of 4 studies, the ORR is refreshingly positive, and logical that it works mainly in DLL3-high NEC. Serious treatment-related side effects were seen in about 1 in 5 patients, so its tolerable. Time to make mass spec proteomics standard!

Source: Read the original publication

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