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Pasotuxizumab, a BiTE ® immune therapy for castration-resistant prostate cancer: Phase I, dose-escalation study findings.
- Source :
-
Immunotherapy [Immunotherapy] 2021 Feb; Vol. 13 (2), pp. 125-141. Date of Electronic Publication: 2020 Nov 10. - Publication Year :
- 2021
-
Abstract
- Aim:  We report results of a first-in-human study of pasotuxizumab, a PSMA bispecific T-cell engager (BiTE <superscript>®</superscript> ) 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).
- Subjects :
- Aged
Aged, 80 and over
Humans
Male
Middle Aged
Antigens, Surface immunology
Biomarkers, Tumor blood
CD3 Complex immunology
Glutamate Carboxypeptidase II immunology
Immunotherapy
Infusions, Intravenous
Injections, Subcutaneous
Maximum Tolerated Dose
Treatment Outcome
Antibodies, Bispecific immunology
Antibodies, Bispecific pharmacokinetics
Antibodies, Bispecific therapeutic use
Antineoplastic Agents, Immunological immunology
Antineoplastic Agents, Immunological pharmacokinetics
Antineoplastic Agents, Immunological therapeutic use
Prostatic Neoplasms, Castration-Resistant blood
Prostatic Neoplasms, Castration-Resistant immunology
Prostatic Neoplasms, Castration-Resistant pathology
Prostatic Neoplasms, Castration-Resistant therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1750-7448
- Volume :
- 13
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- Immunotherapy
- Publication Type :
- Academic Journal
- Accession number :
- 33172323
- Full Text :
- https://doi.org/10.2217/imt-2020-0256