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

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

Johnson & Johnson unveils first-in-human results for pasritamig, showing early anti-tumor activity in prostate cancer (J&J Press Release) - P1 | N=260 | NCT04898634 | Sponsor: Janssen Research & Development, LLC | "Johnson & Johnson announced today new data from a Phase 1 study evaluating pasritamig (JNJ-78278343), a first-in-class bispecific antibody that activates T-cells to harness the body’s immune system against prostate cancer cells, showing promise in patients with advanced disease who have progressed after multiple lines of therapy....Of the patients in the RP2D efficacy group (n=33), treated once every six weeks, 42.4 percent achieved a 50 percent or greater reduction in their prostate-specific antigen (PSA) levels with a median rPFS of 7.9 months (95 percent confidence interval [CI] 2.9, not estimable [NE]) and 21.2 percent of patients continuing therapy. Treatment with pasritamig showed durable disease control and rPFS that compares favorably to historical data in heavily pretreated patients with mCRPC."

P1 data • Castration-Resistant Prostate Cancer

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

A Study of JNJ-78278343 in Combination With Either JNJ-63723283 (Cetrelimab), Taxane Chemotherapy, or Androgen Receptor Pathway Inhibitors for Metastatic Prostate Cancer (clinicaltrials.gov) - P1 | N=213 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: Jun 2025 ➔ Jun 2026

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

JNJ-8343: Data from P1 trial (NCT04898634) for advanced prostate cancer in 2025 (J&J) - 2025 Key Events

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

CR108817: A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer (clinicaltrials.gov) - P1 | N=257 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Sep 2027 ➔ May 2028 | Trial primary completion date: Sep 2027 ➔ May 2028

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

CR108817: A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer (clinicaltrials.gov) - P1 | N=232 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Aug 2028 ➔ Sep 2027

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

A Study of JNJ-87189401 Plus JNJ-78278343 for Advanced Prostate Cancer (clinicaltrials.gov) - P1 | N=130 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Jun 2027 ➔ Oct 2027

Trial completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • 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 | Trial primary completion date: Nov 2024 ➔ Feb 2026

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

A Study of JNJ-78278343 in Combination With Either JNJ-63723283 (Cetrelimab), Taxane Chemotherapy, or Androgen Receptor Pathway Inhibitors for Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=200 | Recruiting | Sponsor: Janssen Research & Development, LLC | N=345 ➔ 200

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

A phase I, first-in-human, open-label, multicenter, trial-in-progress of the safety, tolerability, and preliminary efficacy of JNJ-87189401 (PSMA-CD28 bispecific antibody) combined with JNJ-78278343 (KLK2-CD3 bispecific antibody) for advanced prostate cancer (ESMO 2024) - P1 | "Secondary objectives: preliminary efficacy (objective response rate, duration of response, PSA response rate), pharmacokinetics, and immunogenicity. Enrollment (N≈110) is ongoing."

Clinical • Metastases • P1 data • Carcinoid Tumor • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • KLK2

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 | Trial completion date: Nov 2025 ➔ Feb 2026

Metastases • Trial completion date • 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 in Combination With Either JNJ-63723283 (Cetrelimab), Taxane Chemotherapy, or Androgen Receptor Pathway Inhibitors for Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=345 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Mar 2026 ➔ Sep 2027

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

A Study of JNJ-78278343 in Combination With Either JNJ-63723283 (Cetrelimab), Taxane Chemotherapy, or Androgen Receptor Pathway Inhibitors for Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=345 | Recruiting | Sponsor: Janssen Research & Development, LLC | N=20 ➔ 345

Combination therapy • Enrollment change • Metastases • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study of JNJ-78278343 in Combination With JNJ-63723283 (Cetrelimab) for Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Janssen Research & Development, LLC | Phase classification: P1b ➔ P1

Combination therapy • Metastases • Phase classification • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate 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=165 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Nov 2024 ➔ Nov 2025

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

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

Enrollment open • Metastases • Genito-urinary Cancer • Oncology • 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 in Combination With JNJ-63723283 (Cetrelimab) for Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P1b | N=20 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Jun 2026 ➔ Dec 2025

Combination therapy • Metastases • Trial completion date • 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

A Study of JNJ-78278343 in Combination With JNJ-63723283 (Cetrelimab) for Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P1b | N=20 | Recruiting | Sponsor: Janssen Research & Development, LLC | Not yet recruiting ➔ Recruiting | N=40 ➔ 20

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

A Study of JNJ-78278343 in Combination With JNJ-63723283 (Cetrelimab) for Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P1b | N=40 | Not yet recruiting | Sponsor: Janssen Research & Development, LLC

Combination therapy • 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=160 | Recruiting | Sponsor: Janssen Research & Development, LLC | N=110 ➔ 160 | Trial completion date: Dec 2023 ➔ Nov 2024

Enrollment change • Metastases • Trial completion date • 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