voxalatamab (JNJ-63898081) / J&J - LARVOL DELTA

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 • Metastases • Mismatch repair • Tumor mutational burden • Genito-urinary Cancer • Immune Modulation • Microsatellite Instability • Oncology • Prostate Cancer • Solid Tumor • MSI • TMB

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."

IO biomarker • Journal • Metastases • P1 data • Genito-urinary Cancer • Inflammation • Oncology • Prostate Cancer • Solid Tumor

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 • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • FOLH1

A Study of JNJ-63898081 in Participants With Advanced Stage Solid Tumors (clinicaltrials.gov) - P1; N=40; Completed; Sponsor: Janssen Research & Development, LLC; Active, not recruiting ➔ Completed; Trial completion date: Nov 2022 ➔ Sep 2021

Clinical • Trial completion • Trial completion date • Oncology • Renal Cell Carcinoma • Solid Tumor

A Study of JNJ-63898081 in Participants With Advanced Stage Solid Tumors (clinicaltrials.gov) - P1; N=40; Active, not recruiting; Sponsor: Janssen Research & Development, LLC; Recruiting ➔ Active, not recruiting; N=90 ➔ 40

Clinical • Enrollment change • Enrollment closed • Oncology • Renal Cell Carcinoma • Solid Tumor

A Study of JNJ-63898081 in Participants With Advanced Stage Solid Tumors (clinicaltrials.gov) - P1; N=90; Recruiting; Sponsor: Janssen Research & Development, LLC; Trial completion date: Oct 2021 ➔ Nov 2022

Clinical • Trial completion date • Neuroendocrine Tumor • Oncology • Solid Tumor

[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"

IO Biomarker • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • FOLH1

A Study of JNJ-63898081 in Participants With Advanced Stage Solid Tumors (clinicaltrials.gov) - P1; N=70; Recruiting; Sponsor: Janssen Research & Development, LLC; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

A Study of JNJ-63898081 in Participants With Advanced Stage Solid Tumors (clinicaltrials.gov) - P1; N=70; Not yet recruiting; Sponsor: Janssen Research & Development, LLC

Clinical • New P1 trial