Fcγ Receptor Polymorphism in Patients with Relapsed/Refractory High-Risk Neuroblastoma Correlates with Outcomes in the SIOPEN Dinutuximab Beta Long-Term Infusion Trial.

ABSTRACT:

Purpose

To identify a tolerable dinutuximab beta long-term infusion (LTI) schedule with immunomodulatory activity for relapsed/refractory high-risk neuroblastoma (HRNBL).

Patients and methods

In this phase I/II trial, dinutuximab beta LTI (five 35-day cycles) with subcutaneous interleukin-2 (IL-2) was evaluated in HRNBL cohorts (1× exploratory and 2× confirmatory). The composite primary endpoint was >80% patients free of intravenous morphine by day 5/cycle 1 plus ≥100 natural killer (NK) cells/μL and ≥1 μg/mL dinutuximab beta concentration by day 15/cycle 1. Secondary endpoints included objective response rate, event-free survival (EFS), overall survival (OS), Fcγ receptor (FCYR) polymorphisms, and NK cells.

Results

Overall, 122 patients were treated. At 10 mg/m2/day

SUBMITTER: Lode HN 

PROVIDER: S-EPMC12402781 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature