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    DRUG:

    Zejula (niraparib)

    i
    Other names: GSK3985771, GSK 3985771, JNJ64091742, MK4827, ZL2306, JNJ 64091742, MK 4827, ZL 2306, GTPL 8275, GTPL-8275, MK-4827, JNJ-64091742, ZL-2306, GSK-3985771, GTPL8275
    Company:
    GSK, J&J, Medison, Takeda, ZAI Lab
    Drug class:
    PARP inhibitor
    Related drugs:
    16h
    Phase II Trial of the PARP Inhibitor Niraparib and PD-1 Inhibitor Dostarlimab in Patients With Advanced Cancers With Active Progressing Brain Metastases (STARLET) (clinicaltrials.gov)
    P2, N=120, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Feb 2026 --> Dec 2029 | Trial primary completion date: Feb 2026 --> Dec 2029
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1) • HRD (Homologous Recombination Deficiency) • CDK12 (Cyclin dependent kinase 12) • CHEK2 (Checkpoint kinase 2) • RAD51 (RAD51 Homolog A) • RAD51B (RAD51 Paralog B) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1) • RAD51C (RAD51 paralog C) • RAD51D (RAD51 paralog D) • CHEK1 (Checkpoint kinase 1) • RAD54L (DNA Repair And Recombination Protein RAD54) • FANCL (FA Complementation Group L) • RAD52 (RAD52 Homolog DNA Repair Protein)
    |
    PD-L1 expression
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    Zejula (niraparib) • Jemperli (dostarlimab-gxly)
    2d
    Comparison of Different Maintenance Treatment Options for Newly Diagnosed BRCAwt Advanced Ovarian Cancer: A Retrospective Cohort Analysis. (PubMed, Technol Cancer Res Treat)
    In the PSM sensitivity analysis, the median PFS was not reached (95% CI, 19.55-NR) in the niraparib group and was 18.33 months (95% CI, 8.90-25.26) in the bevacizumab group (HR = 0.360, 95% CI, 0.176-0.736; P = .005).ConclusionThis analysis suggests that niraparib may provide a progression-free survival advantage compared with bevacizumab in BRCAwt AOC patients, with both regimens appearing to be generally well tolerated in the real-world setting. These findings offer preliminary reference value for maintenance treatment selection in patients with newly diagnosed BRCAwt AOC.
    Clinical • Retrospective data • Journal
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    HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
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    HRD • BRCA wild-type
    |
    Avastin (bevacizumab) • Zejula (niraparib)
    4d
    A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Anticancer Activity of GSK4524101 Alone or With Niraparib in Participants With Solid Tumors (clinicaltrials.gov)
    P1/2, N=42, Active, not recruiting, GlaxoSmithKline | Recruiting --> Active, not recruiting | N=135 --> 42 | Trial completion date: Jun 2027 --> Jun 2026 | Trial primary completion date: Jun 2027 --> Jun 2026
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Zejula (niraparib)
    5d
    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 2026 --> Jan 2027 | Trial primary completion date: Jan 2026 --> Jan 2027
    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)
    8d
    Abemaciclib and Niraparib Before Surgery for the Treatment of Hormone Receptor Positive HER2 Negative Breast Cancer (clinicaltrials.gov)
    P1, N=8, Completed, OHSU Knight Cancer Institute | Active, not recruiting --> Completed | Trial completion date: Dec 2025 --> Jun 2025
    Trial completion • Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    Verzenio (abemaciclib) • Zejula (niraparib)
    10d
    A Study of ART4215 for the Treatment of Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=93, Completed, Artios Pharma Ltd | N=390 --> 93 | Active, not recruiting --> Completed
    Trial completion • Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
    |
    HER-2 negative
    |
    Talzenna (talazoparib) • Zejula (niraparib) • ART4215
    11d
    Stage IVB ovarian carcinosarcoma in BRCA wild-type patients: two case reports of unexpected long-term remission. (PubMed, Front Oncol)
    Post-recurrence, she received off-label maintenance with tamoxifen 20 mg daily for five years and remains disease-free at 70 months...Postoperative chemotherapy with carboplatin-paclitaxel was followed by maintenance niraparib 100 mg twice daily for three years...Complete cytoreductive surgery combined with tailored systemic and maintenance therapies can achieve sustained remission even in advanced-stage BRCA-wild-type patients. Broader molecular profiling and international collaboration are essential to refine management strategies for this rare and aggressive malignancy.
    Journal • BRCA Biomarker • PARP Biomarker
    |
    ER (Estrogen receptor) • BRCA (Breast cancer early onset)
    |
    BRCA wild-type • BRCA mutation
    |
    carboplatin • paclitaxel • tamoxifen • Zejula (niraparib)
    12d
    Patient-reported outcomes after long-term period of niraparib maintenance in platinum-sensitive recurrent ovarian cancer: a prospective, multicenter cohort study. (PubMed, J Ovarian Res)
    PRO-based surveillance showed satisfactory QOL and stable symptom control in PSROC after long-term period of niraparib maintenance, regardless of BRCA status. This real-world research highlights the significance of long-term usage of niraparib and PROs in PSROC management.
    Journal • BRCA Biomarker • PARP Biomarker • Platinum sensitive
    |
    BRCA (Breast cancer early onset)
    |
    BRCA wild-type • BRCA mutation
    |
    Zejula (niraparib)
    12d
    Targeting ZDHHC12-mediated PARP1 palmitoylation potentiates PARP inhibitor cytotoxicity. (PubMed, Cell Rep)
    ZDHHC12 knockdown restores PARP1 trapping and resensitizes resistant cells and xenografts to Niraparib. These findings establish ZDHHC12-mediated PARP1 palmitoylation as a targetable vulnerability to overcome PARPi resistance.
    Journal • PARP Biomarker
    |
    FAS (Fas cell surface death receptor) • ZDHHC12 (Zinc Finger DHHC-Type Palmitoyltransferase 12)
    |
    Zejula (niraparib)
    13d
    Niraparib in Tumors Metastatic to the CNS (clinicaltrials.gov)
    P2, N=20, Active, not recruiting, Massachusetts General Hospital | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial primary completion date
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • BAP1 (BRCA1 Associated Protein 1) • RAD51B (RAD51 Paralog B) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1) • RAD51C (RAD51 paralog C) • RAD50 (RAD50 Double Strand Break Repair Protein) • PARP1 (Poly(ADP-Ribose) Polymerase 1) • BARD1 (BRCA1 Associated RING Domain 1) • NBN (Nibrin Nijmegen Breakage Syndrome 1 (Nibrin)) • RAD54L (DNA Repair And Recombination Protein RAD54) • XRCC2 (X-Ray Repair Cross Complementing 2) • RAD54B (RAD54 Homolog B) • XRCC3 (X-Ray Repair Cross Complementing 3)
    |
    HRD • ATM mutation • PALB2 mutation • BRIP1 mutation • RAD51C mutation • RAD51D mutation • RAD51B mutation • BARD1 mutation • RAD54L mutation
    |
    Zejula (niraparib)
    13d
    TBCRC 050: Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer (clinicaltrials.gov)
    P1/2, N=46, Active, not recruiting, University of Alabama at Birmingham | Trial completion date: Dec 2026 --> Dec 2027 | Trial primary completion date: Nov 2026 --> Nov 2027
    Trial completion date • Trial primary completion date
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    PGR (Progesterone receptor)
    |
    PGR positive • EGFR positive
    |
    Herceptin (trastuzumab) • Zejula (niraparib)
    14d
    Combined targeting poly (ADP-ribose) polymerase and receptor tyrosine kinase inhibits ovarian clear cell carcinoma progression through disrupted ribosome biogenesis. (PubMed, J Mol Med (Berl))
    Here we show that combination of niraparib and lenvatinib exhibits significant synergistic inhibitory effects against platinum-resistant OCCC cell lines, xenografts, patient-derived tumoroid (PDT) models, and prolonged survival in the platinum-refractory patient-derived xenograft (PDX) model. RNA sequencing revealed that the most differentially expressed genes in PDX models treated with this combination were associated with structural ribosomal components. This combination suppresses Src phosphorylation, NPM1 expression, and ribosomal protein levels in OCCC.
    Journal • PARP Biomarker
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    NPM1 (Nucleophosmin 1) • ARID1A (AT-rich interaction domain 1A)
    |
    ARID1A mutation
    |
    Lenvima (lenvatinib) • Zejula (niraparib)