Abstract
Ch14.18 manufactured in Chinese hamster ovary (CHO) cells is currently being evaluated in clinical trials. Short-term infusion (STI) (8-20 h/day; 4-5 days) of 100 mg/m2 ch14.18/CHO (dinutiximab β) per cycle in combination with cytokines is standard treatment of neuroblastoma (NB) patients. As pain is a limiting factor, we investigated a novel delivery method by continuous long-term infusion (LTI) of 100 mg/m2 over 10 days. 53 NB patients were treated with 5-6 cycles of 6 × 106 IU/m2 subcutaneous interleukin-2 (d 1-5, 8-12), LTI of 100 mg/m2 ch14.18/CHO (d 8-18) and 160 mg/m2 oral 13-cis-retinoic acid (d 22-35). Human anti-chimeric antibody (HACA), antibody-dependent cell-mediated cytotoxicity and complement-dependent cytotoxicity were determined. With LTI, we observed a maximum concentration of ch14.18/CHO (Cmax) of 12.56 ± 0.68 µg/ml and a terminal half-life time (t1/2 β) of 32.7 ± 16.2 d. The clearance values for LTI and STI of 0.54 ± 0.13 and 0.41 ± 0.29 L/d m2 and area under the serum concentration-time curve (AUC) values of 189.6 ± 41.4 and 284.8 ± 156.8 µg×d/ml, respectively, were not significantly different. Importantly, we detected ch14.18/CHO trough concentration of ≥ 1 µg/ml at time points preceding subsequent antibod...Continue Reading
References
Dec 1, 1995·Cancer Immunology, Immunotherapy : CII·M M Uttenreuther-FischerA L Yu
Jan 1, 1997·Pain·W H XiaoL S Sorkin
Apr 18, 2003·Cancer Immunology, Immunotherapy : CII·Gerald L DeNardoSally J DeNardo
Dec 10, 2003·Pharmaceutical Research·Binodh DeSilvaAbbie Celniker
Jun 14, 2005·Molecular Immunology·Yan ZengHolger N Lode
Mar 17, 2007·Cancer Investigation·Shakeel Modak, Nai-Kong V Cheung
Sep 3, 2009·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Martin A CheeverLynn M Matrisian
Apr 24, 2010·Nature Reviews. Immunology·Louis M WeinerShangzi Wang
Oct 1, 2010·The New England Journal of Medicine·Alice L YuUNKNOWN Children's Oncology Group
Nov 3, 2010·Drugs of the Future·Richard K Yang, Paul M Sondel
Apr 18, 2013·Cancer Immunology, Immunotherapy : CII·Holger N LodeNikolai Siebert
Aug 9, 2013·MAbs·Ruth LadensteinHolger N Lode
Sep 24, 2013·Journal of Immunological Methods·Nikolai SiebertHolger N Lode
Apr 15, 2014·Journal of Immunological Methods·Nikolai SiebertHolger N Lode
Sep 13, 2014·Cancer Chemotherapy and Pharmacology·Ami V DesaiFrank M Balis
Sep 17, 2014·PloS One·Nikolai SiebertHolger N Lode
Citations
Oct 30, 2016·MAbs·Beate HintersteinerAlois Jungbauer
Nov 11, 2016·Nature Reviews. Disease Primers·Katherine K MatthayWilliam A Weiss
Jan 20, 2018·Pediatric Blood & Cancer·Kiraz CeylanHolger N Lode
Oct 17, 2018·JAMA Oncology·Brian H KushnerNai-Kong Cheung
Mar 22, 2019·Journal of Pediatric Hematology/oncology·Julie Voeller, Paul M Sondel
Nov 10, 2017·MAbs·Ina MuellerHolger N Lode
Feb 9, 2017·Oncotarget·Amanda TivnanJochen H M Prehn
Mar 25, 2018·Cell and Tissue Research·Vanessa P Tolbert, Katherine K Matthay
Oct 20, 2018·Cancers·Nikolai SiebertHolger N Lode
Dec 22, 2016·Oncoimmunology·Nikolai SiebertHolger N Lode
Apr 30, 2019·Frontiers in Immunology·Heinz KohlerThomas Kieber-Emmons
Feb 28, 2020·Cancers·Celina L SzantoStefan Nierkens
Nov 11, 2017·Oncoimmunology·Nikolai SiebertHolger N Lode
Aug 15, 2017·European Journal of Pediatrics·Francesco CeppiRaffaele Renella
Nov 18, 2017·Oncoimmunology·Irene Y CheungNai-Kong V Cheung
Oct 25, 2017·Expert Opinion on Orphan Drugs·Mark A ApplebaumSusan L Cohn
Aug 7, 2017·Expert Review of Anticancer Therapy·Sameer Sait, Shakeel Modak
Feb 6, 2017·Journal of Immunology Research·Julien FleurenceStéphane Birklé
Oct 4, 2017·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Amy K ErbePaul M Sondel
Dec 1, 2020·Molecular Oncology·Esther CoronadoJaime Font de Mora
Apr 4, 2021·Journal of Personalized Medicine·Nadiya BayevaOlga Piskareva
Jan 29, 2021·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Alice L YuPaul M Sondel
Aug 10, 2021·Frontiers in Immunology·Christian Martin SeitzPatrick Schlegel