^
    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
    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)
    4d
    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
    6d
    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
    9d
    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)
    9d
    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
    16d
    BRCA1-Mutant Ovarian Cancer with an Unusual Presentation of Leptomeningeal Disease Early in the Course of Treatment: A Case Report. (PubMed, Case Rep Oncol)
    A trial of the PARP inhibitor niraparib was initiated, but the patient deteriorated rapidly and died 6 weeks after presenting with headache...This case posed challenges both in diagnosis and in management, with limited evidence available to guide choice of therapy. Unfortunately, the response to PARP inhibitor in this patient could not be assessed due to her rapid deterioration.
    Journal • BRCA Biomarker • PARP Biomarker
    |
    BRCA1 (Breast cancer 1, early onset) • MUC16 (Mucin 16, Cell Surface Associated)
    |
    BRCA1 mutation
    |
    Zejula (niraparib)
    16d
    Survival Outcomes and Sensitivity of PARP Inhibitors in Platinum-Sensitive Ovarian Cancer: A Retrospective Study. (PubMed, Cancer Med)
    PARPi maintenance therapy demonstrates substantial clinical benefit in real-world Chinese patients with ovarian cancer. However, over 20% exhibit primary resistance. TFRC and PRNP represent promising biomarkers for predicting PARPi sensitivity and warrant further validation.
    Retrospective data • Journal • PARP Biomarker • Platinum sensitive
    |
    HIF1A (Hypoxia inducible factor 1, alpha subunit) • PRNP (Prion Protein)
    |
    Lynparza (olaparib) • Zejula (niraparib)
    18d
    Niraparib and Dostarlimab for the Treatment of Small Cell Lung Cancer and Other High-Grade Neuroendocrine Carcinomas (clinicaltrials.gov)
    P2, N=48, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Apr 2026 --> Apr 2027 | Trial primary completion date: Apr 2026 --> Apr 2027
    Trial completion date • Trial primary completion date
    |
    Zejula (niraparib) • Jemperli (dostarlimab-gxly)
    18d
    Niraparib With Abiraterone Acetate Plus Prednisone as First-Line Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer With Homologous Recombination Repair Gene Alterations: Final Analysis of the Asian Subgroup From the MAGNITUDE Study. (PubMed, Int J Urol)
    In this final exploratory analysis of the Asian subgroup, participants with BRCA + mCRPC continued to benefit from first-line treatment with niraparib + AAP in comparison to placebo + AAP, with efficacy and toxicity profiles consistent with the global study population.
    Clinical • Journal • BRCA Biomarker • PARP Biomarker
    |
    BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
    |
    Zejula (niraparib) • abiraterone acetate • prednisone
    22d
    Identification of novel drug-specific PARP inhibitor resistance mechanisms in ovarian cancer-implications for clinical practice. (PubMed, Br J Cancer)
    Treatment-induced BCRP/ABCG2 induction is a novel clinically relevant niraparib resistance biomarker. Routine inclusion of paclitaxel in first-line chemotherapy regimens may promote efflux transporter-mediated resistance, compromising response to PARPi maintenance treatment.
    Journal • PARP Biomarker
    |
    ABCB1 (ATP Binding Cassette Subfamily B Member 1) • ABCG2 (ATP Binding Cassette Subfamily G Member 2)
    |
    Lynparza (olaparib) • carboplatin • paclitaxel • Zejula (niraparib)