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pasritamig (JNJ-8343)
i
Other names: JNJ-8343, JNJ-78278343, JNJ78278343, JNJ8343, JNJ 78278343, JNJ 8343
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Company:
J&J, Zymeworks
Drug class:
CD3 agonist, KLK2 inhibitor
Related drugs:
3d
Redefining standards: a comprehensive systematic review of practice changing advances in GU oncology from ASCO and ESMO 2025. (PubMed, Front Endocrinol (Lausanne))
Key advances include: (1) In bladder cancer, perioperative durvalumab (NIAGARA) and enfortumab vedotin plus pembrolizumab (KEYNOTE-905/EV-303) set new standards, while HER2-targeted disitamab vedotin plus toripalimab (RC48-C016) improved metastatic survival...(3) In prostate cancer, enzalutamide plus leuprolide improved survival in high-risk biochemical recurrence (EMBARK). Capivasertib plus abiraterone benefited PTEN-deficient metastatic hormone-sensitive disease (CAPItello-281). The PSMAddition trial demonstrated that adding [177Lu]Lu-PSMA-617 to standard therapy significantly improved radiographic PFS in PSMA-positive mHSPC. Docetaxel scheduling was optimized (ARASAFE), and an AI model (STAMPEDE) identified patients for AR inhibitor benefit. Novel agents like saruparib and pasritamig showed promise...The 2025 evidence establishes multiple new standards of care across GU cancers, emphasizing biomarker-driven strategies, immunotherapy integration, novel resistance mechanisms, and treatment optimization. This synthesis provides an evidence-based framework for updating guidelines and highlights the move toward more personalized management, while noting persistent challenges and future research needs.
Review • Journal • PD(L)-1 Biomarker • IO biomarker
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HER-2 (Human epidermal growth factor receptor 2) • PTEN (Phosphatase and tensin homolog)
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FOLH1 positive
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Keytruda (pembrolizumab) • Imfinzi (durvalumab) • docetaxel • Loqtorzi (toripalimab-tpzi) • Xtandi (enzalutamide) • abiraterone acetate • Truqap (capivasertib) • Aidixi (disitamab vedotin) • Padcev (enfortumab vedotin-ejfv) • saruparib (AZD5305) • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • leuprolide acetate for depot suspension • pasritamig (JNJ-8343)
6d
KLK2-PASenger: A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
P3, N=800, Recruiting, Janssen Research & Development, LLC | N=171 --> 800
Enrollment change • Trial initiation date
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docetaxel • prednisone • pasritamig (JNJ-8343)
7d
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, Janssen Research & Development, LLC | Trial primary completion date: Feb 2026 --> Feb 2027
Trial primary completion date
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pasritamig (JNJ-8343)
13d
KLK2-comPAS: A Study of Pasritamig Versus Placebo in Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC) (clinicaltrials.gov)
P3, N=663, Recruiting, Janssen Research & Development, LLC
Trial initiation date
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BRCA (Breast cancer early onset)
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BRCA mutation
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pasritamig (JNJ-8343)
19d
A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer (clinicaltrials.gov)
P1, N=300, Recruiting, Janssen Research & Development, LLC | Trial completion date: Sep 2027 --> May 2028 | Trial primary completion date: Jun 2026 --> Aug 2027
Trial completion date • Trial primary completion date
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docetaxel • Xtandi (enzalutamide) • abiraterone acetate • prednisone • Nubeqa (darolutamide) • cabazitaxel • apalutamide • cetrelimab (JNJ-63723283) • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • pasritamig (JNJ-8343)
26d
KLK2-PASenger: A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
P3, N=171, Recruiting, Janssen Research & Development, LLC | Not yet recruiting --> Recruiting
Enrollment open
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IL6 (Interleukin 6)
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docetaxel • prednisone • pasritamig (JNJ-8343)
1m
KLK2-PASenger: A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
P3, N=138, Recruiting, Janssen Research & Development, LLC | N=63 --> 138
Enrollment change
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IL6 (Interleukin 6)
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docetaxel • prednisone • pasritamig (JNJ-8343)
1m
78278343PCR3003: Pasritamig With Docetaxel vs Docetaxel in Metastatic Castration-resistant Prostate Cancer (mCRPC) (2025-522713-29-00)
P2/3, N=63, Not yet recruiting, Janssen Cilag International
New P2/3 trial
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docetaxel • prednisone • pasritamig (JNJ-8343)
2ms
A Study of JNJ-87189401 Plus JNJ-78278343 for Advanced Prostate Cancer (clinicaltrials.gov)
P1, N=250, Recruiting, Janssen Research & Development, LLC | Trial completion date: Oct 2027 --> Jun 2028
Trial completion date
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pasritamig (JNJ-8343)
2ms
78278343PCR3001: Pasritamig vs Placebo in late line Metastatic Castration-resistant Prostate Cancer (mCRPC) (2025-520927-26-00)
P2/3, N=247, Recruiting, Janssen Cilag International
New P2/3 trial
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BRCA (Breast cancer early onset)
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BRCA mutation
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pasritamig (JNJ-8343)
2ms
CR108817: A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer (clinicaltrials.gov)
P1, N=144, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Oct 2027 --> Jan 2027 | Trial primary completion date: Oct 2027 --> Jan 2027
Trial completion date • Trial primary completion date
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JNJ-6420 • pasritamig (JNJ-8343)
2ms
A Study of JNJ-78278343 in Combination With JNJ-95298177 for Treatment of Prostate Cancer (clinicaltrials.gov)
P1, N=140, Recruiting, Janssen Research & Development, LLC | Trial completion date: Sep 2027 --> Mar 2027 | Trial primary completion date: Sep 2027 --> Jan 2027
Trial completion date • Trial primary completion date
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AR (Androgen receptor)
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JNJ-8177 • pasritamig (JNJ-8343)
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