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Pasotuxizumab, a BiTE® immune therapy for castration-resistant prostate cancer: phase I, dose-escalation study findings

Aim: We report results of a first-in-human study of pasotuxizumab, a PSMA bispecific T-cell engager (BiTE®) immune therapy mediating T-cell killing of tumor cells in patients with advanced castration-resistant prostate cancer. Patients & methods: We assessed once-daily subcutaneous (SC) pasotuxi...

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Main Authors: Hummel, Horst-Dieter (Author) , Kufer, Peter (Author) , Grüllich, Carsten (Author) , Seggewiss-Bernhardt, Ruth (Author) , Deschler-Baier, Barbara (Author) , Chatterjee, Manik (Author) , Goebeler, Maria-Elisabeth (Author) , Miller, Kurt (Author) , de Santis, Maria (Author) , Loidl, Wolfgang (Author) , Dittrich, Christian (Author) , Buck, Andreas (Author) , Lapa, Constantin Frederik Victor (Author) , Thurner, Annette (Author) , Wittemer-Rump, Sabine (Author) , Koca, Gökben (Author) , Boix, Oliver (Author) , Döcke, Wolf-Dietrich (Author) , Finnern, Ricarda (Author) , Kusi, Helena (Author) , Ajavon-Hartmann, Antoinette (Author) , Stienen, Sabine (Author) , Sayehli, Cyrus Michael (Author) , Polat, Bülent (Author) , Bargou, Ralf C. (Author)
Format: Article (Journal)
Language:English
Published: February 2021
In: Immunotherapy
Year: 2021, Volume: 13, Issue: 2, Pages: 125-141
ISSN:1750-7448
DOI:10.2217/imt-2020-0256
Online Access:Verlag, kostenfrei, Volltext: https://doi.org/10.2217/imt-2020-0256
Verlag, kostenfrei, Volltext: https://www.futuremedicine.com/doi/10.2217/imt-2020-0256
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Author Notes:Horst-Dieter Hummel, Peter Kufer, Carsten Grüllich, Ruth Seggewiss-Bernhardt, Barbara Deschler-Baier, Manik Chatterjee, Maria-Elisabeth Goebeler, Kurt Miller, Maria de Santis, Wolfgang Loidl, Christian Dittrich, Andreas Buck, Constantin Lapa, Annette Thurner, Sabine Wittemer-Rump, Gökben Koca, Oliver Boix, Wolf-Dietrich Döcke, Ricarda Finnern, Helena Kusi, Antoinette Ajavon-Hartmann, Sabine Stienen, Cyrus Michael Sayehli, Bülent Polat & Ralf C Bargou
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Summary:Aim: We report results of a first-in-human study of pasotuxizumab, a PSMA bispecific T-cell engager (BiTE®) immune therapy mediating T-cell killing of tumor cells in patients with advanced castration-resistant prostate cancer. Patients & methods: We assessed once-daily subcutaneous (SC) pasotuxizumab. All SC patients developed antidrug antibodies; therefore, continuous intravenous (cIV) infusion was assessed. Results: A total of 47 patients received pasotuxizumab (SC: n = 31, 0.5-172 μg/d; cIV: n = 16, 5-80 μg/d). The SC maximum tolerated dose was 172.0 μg/d. A sponsor change stopped the cIV cohort early; maximum tolerated dose was not determined. PSA responders occurred (>50% PSA decline: SC, n = 9; cIV, n = 3), including two long-term responders. Conclusion: Data support pasotuxizumab safety in advanced castration-resistant prostate cancer and represent evidence of BiTE monotherapy efficacy in solid tumors. - - Clinical trial registration: NCT01723475 (ClinicalTrials.gov)
Item Description:Online veröffentlicht: 11. November 2020
Gesehen am 02.05.2024
Physical Description:Online Resource
ISSN:1750-7448
DOI:10.2217/imt-2020-0256

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