Boehringer Ingelheim has presented new Phase I data from the DAREON-7 trial on obrixtamig at the European Neuroendocrine Tumor Society (ENETS) evaluating the DLL3/CD3 T-cell engager in combination with platinum-etoposide as a first-line approach in DLL3-positive extrapulmonary neuroendocrine carcinomas and related high-grade tumours.
Highlights from this data include:
- Encouraging tumour responses seen with the first-line combination, with three-quarters of patients responding (ORR 75%)
- Progression-free survival approaching eight months, with supportive outcomes at six and nine months (median PFS 7.7 months; 6-month PFS rate 66%; 9-month PFS rate 46%)
- A safety profile consistent with the individual treatments, with no unexpected toxicities observed
- Immune-related side effects were mostly mild, with no severe cytokine release syndrome or notable neurologic events reported (no grade ≥3 CRS; no grade ≥2 ICANS)
Delta-like ligand 3 (DLL3) is an inhibitory Notch ligand that is highly expressed in extrapulmonary neuroendocrine carcinomas and other neuroendocrine cancers but minimally expressed in normal tissues making it a potentially critical biomarker, and these findings support the continued development of DLL3-targeted combination strategies in a rare and aggressive cancer setting with limited treatment options.
DAREON-7 explores a first-line DLL3 combination strategy in a disease setting characterised by limited innovation beyond chemotherapy and poor prognosis.
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