pasritamig (JNJ-8343) / J&J, Zymeworks - LARVOL DELTA

KLK2-PASenger: A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P3 | N=800 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Jul 2029 ➔ Jun 2030

Trial completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

KLK2-comPAS: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Pasritamig plus Best Supportive Care in mCRPC (ESMO 2026) - No abstract available

Clinical • P3 data • Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • KLK2

KLK2-PASenger: A Phase 3 Randomized, Open-label Study of Pasritamig, a T-cell-engager Targeting Human Kallikrein 2, With Docetaxel Versus Docetaxel for mCRPC (ESMO 2026) - No abstract available

Clinical • P3 data • Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • KLK2

Phase 1 study results of JNJ-78278343 (pasritamig) in metastatic castration-resistant prostate cancer (mCRPC). (ASCO 2025) - P1 | "Pre-medication with dexamethasone (16 mg) was required in SU and 1st TD...Pts had a median of 4 prior therapies (range 1-13; 99.4% ARPI, 78.2% taxane chemotherapy, 17.2% lutetium Lu 177 vipivotide tetraxetan)...In the RP2D safety population (n=45; 3.5 mg [Day 1], 18 mg [Day 8], 300 mg Q3W or Q6W IV), the most common TRAEs were infusion-related reactions (22.2%; Gr 1/2), fatigue (15.6%; Gr 1/2), and CRS (8.9%; all Gr 1, no tocilizumab was administered), no TRAEs led to treatment discontinuation, no ICANS was observed, and 2 serious TRAEs (Gr 1 CRS) were reported... Pasritamig was very well tolerated (<10% of pts experienced CRS [all Gr1] at the RP2D) with promising antitumor activity, demonstrating proof of concept for KLK2 as a target amenable to T-cell redirection. These results address an unmet need for a targeted T-cell based therapy that is safe to administer in an outpatient setting with clinically meaningful benefit in mCRPC. Phase 3 trials are planned."

Metastases • P1 data • Castration-Resistant Prostate Cancer • Fatigue • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • KLK2

Clinical Trials of Potentially ‘Game-Changing’ Immunotherapy Drug for Advanced Prostate Cancer Underway at CU Anschutz Cancer Center (University of Colorado Anschutz Medical Campus) - "Two clinical trials underway at the University of Colorado Anschutz Cancer Center may offer new hope to prostate cancer patients who have disease that has spread beyond the prostate gland and is no longer responding to hormone therapies....One of the clinical trials open at the CU Anschutz Cancer Center is a phase III trial testing the efficacy of pasritamig on its own compared to best supportive care; the other is a phase I trial investigating the combination of pasritamig with a second T-cell engager that targets a cancer cell protein called PSMA and T-cell protein CD28."

Trial status • Castration-Resistant Prostate Cancer

Safety and efficacy of pasritamig (PAS) + docetaxel (DOCE) in participants with metastatic castration-resistant prostate cancer (mcrPc): Initial results of a phase 1b study. (ASCO-GU 2026) - P1 | "Pts were heavily pretreated with a median of 3 (range 1–9) prior therapies, including ARPI (100%), DOCE (43.1%), cabazitaxel (21.6%), Lutetium-177 vipivotide tetraxetan (19.6%). PAS was readily combinable with DOCE, demonstrating a safety profile consistent with DOCE alone, no CRS, and promising anti-tumor activity in heavily pretreated patients post-ARPI/taxanes. A confirmatory phase 3 trial is planned."

Clinical • First-in-human • Metastases • P1 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • KLK2

Pasritamig, a First-in-Class, Bispecific T-Cell Engager Targeting Human Kallikrein 2, in Metastatic Castration-Resistant Prostate Cancer: A Phase 1 Study. (PubMed, J Clin Oncol) - "Pasritamig demonstrated a favorable safety profile with very low rates of CRS and could be safely administered in an outpatient setting. Preliminary antitumor activity demonstrated proof of concept for KLK2 as a target in PC, warranting further development of pasritamig."

Journal • P1 data • Castration-Resistant Prostate Cancer • Fatigue • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • KLK2

Translational analyses of T cell phenotypes and their association with clinical efficacy in the first-in-human (FIH) trial of JNJ-78278343 (pasritamig) in metastatic castration-resistant prostate cancer (mCRPC) (ESMO 2025) - P1 | "Conclusions Biomarker analyses of peripheral and tumor-infiltrating T cells support the proposed mechanism of action of pasritamig and recommended RP2D. Pts with a higher percentage of reprogrammable progenitor T cells were more likely to have a PSA50 response."

Clinical • First-in-human • Metastases • P1 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CASP3 • CD8 • KLK2

A phase 3 randomized, open-label study of pasritamig (JNJ-78278343), a T-cell engager targeting human kallikrein-2, with docetaxel versus docetaxel for metastatic castration-resistant prostate cancer. (ASCO 2026) - P1, P3 | "Participants in the DOCE alone arm will also receive continuous prednisone per label. Safety, pharmacokinetics, biomarkers, and quality of life assessments will also be evaluated. The study is currently enrolling patients in the North and Latin Americas, European Union and Asia Pacific regions."

Clinical • Metastases • P3 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • KLK2

KLK2-comPAS: A Study of Pasritamig With or Without JNJ-87189401 Versus Placebo for Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - P3 | N=1203 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: Dec 2027 ➔ Aug 2028

Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • BRCA

A Study of JNJ-78278343 in Combination With JNJ-95298177 for Treatment of Prostate Cancer (clinicaltrials.gov) - P1 | N=140 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Mar 2027 ➔ Dec 2027 | Trial primary completion date: Jan 2027 ➔ Nov 2027

Trial completion date • Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • AR

Business Highlights:…Pasritamig (GlobeNewswire) - "Johnson and Johnson Innovative Medicine (J&J) expect to present Phase 1b clinical data for pasritamig, a first-in-class bispecific antibody against KLK2, in combination with JNJ-9401 in patients with advanced prostate cancer who have progressed after multiple lines of therapy, during the second half of 2026."

P1 data • Prostate Cancer

J&J increased the planned enrollment for its Phase 3 trial of pasritamig (JNJ-78278343) in combination with best supportive care in patients with late-line metastatic castration-resistant prostate cancer (mCRPC), from approximately 663 to 1,203 participants (GlobeNewswire) - "The study is actively recruiting across 172 sites globally and is evaluating overall survival versus placebo, with median overall survival as the primary endpoint. The anticipated primary completion date is now estimated as December 2027, compared with the previously estimated May 2028 date (NCT07164443)."

Enrollment change • Trial completion date • Castration-Resistant Prostate Cancer

A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate Cancer (clinicaltrials.gov) - P1 | N=355 | Recruiting | Sponsor: Janssen Research & Development, LLC | N=250 ➔ 355

Enrollment change • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

KLK2-comPAS: A Study of Pasritamig Versus Placebo in Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - P3 | N=1203 | Recruiting | Sponsor: Janssen Research & Development, LLC | N=663 ➔ 1203

Enrollment change • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • BRCA

KLK2-PASenger: A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P3 | N=800 | Recruiting | Sponsor: Janssen Research & Development, LLC | Initiation date: Apr 2026 ➔ Dec 2025

Trial initiation date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Pasritamig: Data from P1/2 trial (NCT06095089) in combinatioon with JNJ-9401 for advanced prostate cancer in 2026 (J&J) - 2026 Key Events

P1/2 data • Genito-urinary Cancer • Oncology • Prostate Cancer

CR108958: A Study of JNJ-78278343, a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Advanced Prostate Cancer (clinicaltrials.gov) - P1 | N=216 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: Feb 2026 ➔ Feb 2027

Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

A Study of JNJ-87189401 Plus JNJ-78278343 for Advanced Prostate Cancer (clinicaltrials.gov) - P1 | N=110 | Not yet recruiting | Sponsor: Janssen Research & Development, LLC

Metastases • New P1 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study of JNJ-78278343, a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Advanced Prostate Cancer (clinicaltrials.gov) - P1 | N=110 | Recruiting | Sponsor: Janssen Research & Development, LLC | N=70 ➔ 110

Enrollment change • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study of JNJ-78278343, a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Advanced Prostate Cancer (clinicaltrials.gov) - P1 | N=160 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: May 2023 ➔ Nov 2024

Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

KLK2-comPAS: A Study of Pasritamig Versus Placebo in Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - P3 | N=663 | Recruiting | Sponsor: Janssen Research & Development, LLC

Trial initiation date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • BRCA

KLK2-comPAS: A Study of Pasritamig Versus Placebo in Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - P3 | N=663 | Not yet recruiting | Sponsor: Janssen Research & Development, LLC

New P3 trial • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study of JNJ-78278343, a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Advanced Prostate Cancer (clinicaltrials.gov) - P1 | N=260 | Recruiting | Sponsor: Janssen Research & Development, LLC | N=165 ➔ 260

Enrollment change • Metastases • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study of JNJ-78278343, a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Advanced Prostate Cancer (clinicaltrials.gov) - P1 | N=216 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor