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DRUG:

voxalatamab (JNJ-63898081)

i
Other names: JNJ-63898081, JNJ 63898081, JNJ-081, JNJ-8081
Company:
J&J
Drug class:
CD3 agonist, PSMA inhibitor
Related drugs:
over1year
Phase 1 Study of Safety and Preliminary Clinical Activity of JNJ-63898081, a PSMA and CD3 Bispecific Antibody, for Metastatic Castration-Resistant Prostate Cancer. (PubMed, Clin Genitourin Cancer)
JNJ-081 dosing led to transient declines in PSA in patients with mCRPC. CRS and IRR could be partially mitigated by SC dosing, step-up priming, and a combination of both strategies. T cell redirection for prostate cancer is feasible and PSMA is a potential therapeutic target for T cell redirection in prostate cancer.
P1 data • Clinical Trial,Phase I • Journal • IO biomarker • Metastases
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FOLH1 expression
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voxalatamab (JNJ-63898081)
over1year
Re-sensitization to pembrolizumab following PSMA-CD3 T-cell redirection therapy with JNJ-081 in a patient with mismatch repair-deficient metastatic castration-resistant prostate cancer: a case report. (PubMed, J Immunother Cancer)
On progression, he was reinitiated on pembrolizumab and experienced an exceptional second response, with his prostate-specific antigen falling from a high of 20.01 to undetectable after 6 weeks and remaining undetectable for >11 months. To our knowledge, this represents the first reported case of bispecific T-cell engager-mediated re-sensitization to checkpoint inhibitor therapy in any cancer.
Journal • Mismatch repair • Tumor mutational burden • MSi-H Biomarker • PD(L)-1 Biomarker • Metastases
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TMB (Tumor Mutational Burden) • MSI (Microsatellite instability)
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MSI-H/dMMR
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Keytruda (pembrolizumab) • voxalatamab (JNJ-63898081)
almost3years
Safety and preliminary clinical activity of JNJ-63898081 (JNJ-081), a PSMA and CD3 bispecific antibody, for the treatment of metastatic castrate-resistant prostate cancer (mCRPC). (ASCO-GU 2022)
P1 | " This Phase 1 Dose Escalation Study evaluated JNJ-081 in mCRPC participants (pts) who progressed after novel androgen targeting therapy (eg, abiraterone, enzalutamide or apalutamide). JNJ-081 demonstrated transient decreases in PSA in mCRPC patients. Grade 2 CRS was observed at higher doses and was partially mitigated by SC and step-up dosing. ADA resulting in decreased exposure occurred in the majority of pts treated SC."
Clinical
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FOLH1 (Folate hydrolase 1)
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FOLH1 expression
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Xtandi (enzalutamide) • abiraterone acetate • Erleada (apalutamide) • voxalatamab (JNJ-63898081)
4years
[VIRTUAL] Functional Characterization of a Novel PSMA/CD3 Redirection Molecule for the Treatment of Prostate Cancer (PCF 2020)
In addition, JNJ-63898081 was able to effectively cause T cell dependent cytotoxicity of an enzalutamide-resistant LNCaP-AR cell line. Collectively, these data provided the impetus to initiate clinical testing of JNJ-63898081 for the treatment of prostate cancer. Funding Acknowledgments: Janssen R&D
PD(L)-1 Biomarker • IO biomarker
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FOLH1 (Folate hydrolase 1)
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PD-L1 expression
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Xtandi (enzalutamide) • voxalatamab (JNJ-63898081)