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Avelumab in paediatric patients with refractory or relapsed solid tumours: dose-escalation results from an open-label, single-arm, phase 1/2 trial

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  • David M Loeb
  • Ji Won Lee
  • Daniel A Morgenstern
  • Yvan Samson
  • Anne Uyttebroeck
  • Chuhl Joo Lyu
  • An Van Damme
  • Karsten Nysom
  • Margaret E Macy
  • Alexandra P Zorzi
  • Julia Xiong
  • Petra Pollert
  • Ingrid Joerg
  • Yulia Vugmeyster
  • Mary Ruisi
  • Hyoung Jin Kang
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BACKGROUND: We report dose-escalation results from an open-label, phase 1/2 trial evaluating avelumab (anti-PD-L1) in paediatric patients with refractory/relapsed solid tumours.

METHODS: In phase 1, patients aged < 18 years with solid (including central nervous system [CNS]) tumours for which standard therapy did not exist or had failed were enrolled in sequential cohorts of 3-6 patients. Patients received avelumab 10 or 20 mg/kg intravenously every 2 weeks. Primary endpoints were dose-limiting toxicities (DLTs) and grade ≥ 3 treatment-emergent adverse events (AEs).

RESULTS: At data cut-off (27 July 2021), 21 patients aged 3-17 years had received avelumab 10 mg/kg (n = 6) or 20 mg/kg (n = 15). One patient had three events that were classified as a DLT (fatigue with hemiparesis and muscular weakness associated with pseudoprogression; 20 mg/kg cohort). Grade ≥ 3 AEs occurred in five (83%) and 11 (73%) patients in the 10 and 20 mg/kg cohorts, respectively, and were treatment-related in one patient (7%; grade 3 [DLT]) in the 20 mg/kg cohort. Avelumab exposure in paediatric patients receiving 20 mg/kg dosing, but not 10 mg/kg, was comparable or higher compared with approved adult dosing (10 mg/kg or 800 mg flat dose). No objective responses were observed. Four patients with CNS tumours (20 mg/kg cohort) achieved stable disease, which was ongoing in two patients with astrocytoma at cut-off (for 24.7 and 30.3 months).

CONCLUSION: In paediatric patients with refractory/relapsed solid tumours, avelumab monotherapy showed a safety profile consistent with previous adult studies, but clinical benefits were limited.

OriginalsprogEngelsk
TidsskriftCancer Immunology and Immunotherapy
Vol/bind71
Udgave nummer10
Sider (fra-til)2485-2495
Antal sider11
ISSN0340-7004
DOI
StatusUdgivet - okt. 2022

Bibliografisk note

© 2022. The Author(s).

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