^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG:

    Zejula (niraparib)

    i
    Other names: MK-4827, JNJ-64091742, ZL-2306, GSK-3985771, GSK3985771, GSK 3985771, JNJ64091742, MK4827, ZL2306, GTPL-8275, GTPL8275, JNJ 64091742, MK 4827, ZL 2306, GTPL 8275
    Company:
    GSK, J&J, Medison, Takeda, ZAI Lab
    Drug class:
    PARP inhibitor
    Related drugs:
    3d
    A randomized, open-label phase II non-inferiority study of niraparib maintenance after 3 versus 6 cycles of platinum-based chemotherapy in patients with completely debulked advanced HRD-positive high-grade ovarian cancer in first-line therapy (N-PLUS/NOGGO-ov53/ENGOT-ov62). (PubMed, Int J Gynecol Cancer)
    This trial aims to provide high-quality evidence on whether a reduced number of chemotherapy cycles in the era of niraparib maintenance for 3 years can safely maintain efficacy while minimizing treatment-related toxicity and improving patients' quality of life.
    P2 data • Journal • Head-to-Head • BRCA Biomarker • PARP Biomarker
    |
    HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
    |
    HRD • BRCA mutation
    |
    Avastin (bevacizumab) • Zejula (niraparib)
    6d
    Niraparib Before Surgery in Treating Patients With High Risk Localized Prostate Cancer and DNA Damage Response Defects (clinicaltrials.gov)
    P2, N=11, Terminated, University of California, Davis | Active, not recruiting --> Terminated; PI choice; poor accrual
    Trial termination
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • CHEK2 (Checkpoint kinase 2) • RAD51 (RAD51 Homolog A) • FANCA (FA Complementation Group A) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1) • RAD51C (RAD51 paralog C) • CHEK1 (Checkpoint kinase 1) • NBN (Nibrin Nijmegen Breakage Syndrome 1 (Nibrin)) • FANCL (FA Complementation Group L) • FANCD2 (FA Complementation Group D2) • GEN1 (GEN1 Holliday junction 5' flap endonuclease)
    |
    Zejula (niraparib)
    7d
    MONITOR-UK: Multi-Centre Observational Study of Maintenance Niraparib in Treatment of Ovarian CanceR (clinicaltrials.gov)
    P=N/A, N=388, Completed, Royal Marsden NHS Foundation Trust | Recruiting --> Completed | Trial completion date: Feb 2024 --> Apr 2026 | Trial primary completion date: Feb 2024 --> Apr 2026
    Trial completion • Trial completion date • Trial primary completion date
    |
    Zejula (niraparib)
    7d
    Case Report: Niraparib-abiraterone in HRR-mutated metastatic castration-resistant prostate cancer: clinical insights from five cases. (PubMed, Front Oncol)
    Combination therapy with the PARP inhibitor niraparib and the androgen-receptor inhibitor abiraterone acetate plus prednisone (AAP) has recently shown improvement in radiographic progression-free survival (rPFS) in patients with metastatic castration-resistant prostate cancer (mCRPC) harboring homologous recombination repair (HRR) gene alterations, particularly BRCA1/2, in the phase III MAGNITUDE trial. However, the very small sample size, retrospective design, and absence of standardized rPFS assessment limit generalizability. These findings are primarily hypothesis-generating but align with prospective trial results and underscore the heterogeneity of HRR-mutated mCRPC, highlighting the need for individualized therapeutic strategies.
    Journal • BRCA Biomarker • PARP Biomarker
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • PALB2 (Partner and localizer of BRCA2)
    |
    Zejula (niraparib) • abiraterone acetate • prednisone
    9d
    iNNOVATE: Niraparib and Neratinib in Advanced Solid Tumors With Expansion Cohort in Advanced Ovarian Cancer (clinicaltrials.gov)
    P1, N=18, Active, not recruiting, Virginia Commonwealth University | Trial completion date: May 2029 --> Oct 2027
    Trial completion date • Platinum resistant
    |
    Nerlynx (neratinib) • Zejula (niraparib)
    13d
    DDRiver Solid Tumours 301: Tuvusertib (M1774) in Participants With Metastatic or Locally Advanced Unresectable Solid Tumors (DDRiver Solid Tumors 301) (clinicaltrials.gov)
    P1, N=161, Active, not recruiting, EMD Serono Research & Development Institute, Inc. | Trial completion date: Jan 2027 --> Jul 2026 | Trial primary completion date: Jan 2027 --> Jul 2026
    Trial completion date • Trial primary completion date • First-in-human
    |
    ARID1A (AT-rich interaction domain 1A) • ATRX (ATRX Chromatin Remodeler)
    |
    ATM mutation • ARID1A mutation
    |
    Zejula (niraparib) • tuvusertib (M1774)
    14d
    KNIGHTS: High-Risk Metachronous Oligometastatic Prostate Cancer Trial (clinicaltrials.gov)
    P2, N=88, Active, not recruiting, University of Maryland, Baltimore | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    TP53 (Tumor protein P53) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • ATM (ATM serine/threonine kinase) • CHEK2 (Checkpoint kinase 2) • FANCA (FA Complementation Group A) • RAD51B (RAD51 Paralog B) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1) • CD4 (CD4 Molecule) • RAD54L (DNA Repair And Recombination Protein RAD54)
    |
    TP53 mutation • BRCA2 mutation • BRCA1 mutation • ATM mutation • PALB2 mutation • CHEK2 mutation • BRIP1 mutation • RAD51B mutation • RAD54L mutation
    |
    Zejula (niraparib) • abiraterone acetate • prednisone
    16d
    DYRK1B Inhibition by AZ191 Sensitizes High-Grade Serous Ovarian Cancer to Niraparib Through Promoting Apoptosis and Ferroptosis. (PubMed, Biomedicines)
    In addition, the combination therapy induces ferroptosis by inhibiting the Nrf2/SLC7A11/GPX4 axis, thereby exerting cytotoxic effects. Our results uncover a novel mechanism by which inhibiting DYRK1B enhances the anti-HGSOC efficacy of Niraparib and may offer a promising treatment strategy to improve the maintenance therapy in both HRD and HRP ovarian cancer patients.
    Journal • PARP Biomarker
    |
    HRD (Homologous Recombination Deficiency) • GPX4 (Glutathione Peroxidase 4) • SLC7A11 (Solute Carrier Family 7 Member 11) • DYRK1B (Dual Specificity Tyrosine Phosphorylation Regulated Kinase 1B)
    |
    HRD
    |
    Zejula (niraparib) • AZ191
    19d
    ZEAL-1L: Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=666, Completed, GlaxoSmithKline | Active, not recruiting --> Completed
    Trial completion
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • Zejula (niraparib)
    19d
    ASCLEPIuS: A Multi-Center Trial of Androgen Suppression With Abiraterone Acetate, Leuprolide, PARP Inhibition and Stereotactic Body Radiotherapy in Prostate Cancer (clinicaltrials.gov)
    P1/2, N=102, Active, not recruiting, University of Michigan Rogel Cancer Center | Trial completion date: May 2027 --> May 2029 | Trial primary completion date: Nov 2026 --> May 2027
    Trial completion date • Trial primary completion date
    |
    DRD (DNA Repair Deficiency)
    |
    DDR
    |
    Zejula (niraparib) • abiraterone acetate • leuprolide acetate for depot suspension