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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Bibliographic Details
Published in:Immunotherapy 2021-02, Vol.13 (2), p.125-141
Main Authors: Hummel, Horst-Dieter, Kufer, Peter, Grüllich, Carsten, Seggewiss-Bernhardt, Ruth, Deschler-Baier, Barbara, Chatterjee, Manik, Goebeler, Maria-Elisabeth, Miller, Kurt, de Santis, Maria, Loidl, Wolfgang, Dittrich, Christian, Buck, Andreas, Lapa, Constantin, Thurner, Annette, Wittemer-Rump, Sabine, Koca, Gökben, Boix, Oliver, Döcke, Wolf-Dietrich, Finnern, Ricarda, Kusi, Helena, Ajavon-Hartmann, Antoinette, Stienen, Sabine, Sayehli, Cyrus Michael, Polat, Bülent, Bargou, Ralf C
Format: Article
Language:English
Subjects:
Androgens
Antibodies
Antigens
Biomarkers
Bisphosphonates
Castration
Cytokines
Dosage
Intravenous administration
Lymphocytes
Lymphocytes T
Medical prognosis
Metastasis
Patients
Pharmacokinetics
Prostate cancer
Solid tumors
Tumor cells
Tumors
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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)
ISSN:1750-743X
1750-7448
DOI:10.2217/imt-2020-0256