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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:
    2d
    Development of a liquid overlay-based three-dimensional cell culture panel for drug screening applications. (PubMed, Sci Rep)
    Afterwards, the cytostatic and cytotoxic responses of these models to three targeted anti-PARP therapies, Olaparib, Rucaparib and Niraparib, were analyzed, revealing their sensitivity. These results demonstrated that our liquid overlay-based technique provides both a large cell culture panel, whatever the tissue type or pathological level, and an automated drug screening process that could lead to highly predictive efficacy results.
    Preclinical • Journal
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    PARP1 (Poly(ADP-Ribose) Polymerase 1)
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    Lynparza (olaparib) • Zejula (niraparib) • Rubraca (rucaparib)
    3d
    NIRADO: Basket Trial Exploring the Efficacy and Safety of the Combination of Niraparib and Dostarlimab (clinicaltrials.gov)
    P2, N=51, Terminated, Gustave Roussy, Cancer Campus, Grand Paris | Trial completion date: Dec 2027 --> Feb 2025 | Suspended --> Terminated; Abandon of the partner, GSK
    Trial completion date • Trial termination • Pan tumor • Platinum sensitive
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    HER-2 (Human epidermal growth factor receptor 2) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • ARID1A (AT-rich interaction domain 1A) • PBRM1 (Polybromo 1) • CDK12 (Cyclin dependent kinase 12) • 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) • RAD51D (RAD51 paralog D) • ARID2 (AT-Rich Interaction Domain 2) • BARD1 (BRCA1 Associated RING Domain 1) • NBN (Nibrin Nijmegen Breakage Syndrome 1 (Nibrin)) • RAD54L (DNA Repair And Recombination Protein RAD54) • DRD (DNA Repair Deficiency)
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    HER-2 positive • HER-2 amplification • DDR • CDK12 mutation • CHEK2 mutation • BRIP1 mutation • RAD51C mutation • RAD51D mutation • BARD1 mutation
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    Zejula (niraparib) • Jemperli (dostarlimab-gxly)
    4d
    Comprehensive genomic profiling for homologous recombination deficiency guides PARP inhibitor therapy recommendations in ovarian cancer. (PubMed, Pathol Oncol Res)
    PARPi selection differed by HRD status, with niraparib favored in HR-proficient and olaparib in HRD-positive tumors. No additional profiling was required for PARPi therapy recommendation, and no incidental findings beyond the scope of HRD testing were detected. Molecular profiling with F1CDx proved to be a technically feasible, clinically impactful, and time-efficient assay, demonstrating its value in supporting molecular-guided PARPi therapy recommendations in the routine care of HGSOC patients.
    Retrospective data • Journal • BRCA Biomarker • PARP Biomarker
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    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
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    HRD • BRCA mutation
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    FoundationOne® CDx
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    Lynparza (olaparib) • Zejula (niraparib)
    6d
    ANALLISA: Niraparib Rechallenge After Surgery in Ovarian Cancer Patients With Oligometastatic Progression (clinicaltrials.gov)
    P2, N=30, Recruiting, MedSIR | Trial completion date: Nov 2025 --> Jan 2028 | Trial primary completion date: Oct 2025 --> Jan 2028
    Trial completion date • Trial primary completion date
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    Zejula (niraparib)
    8d
    The SP1-SuperEnhancer-SPHK1 Axis Mediates Niraparib Resistance in TNBC. (PubMed, Pharmaceuticals (Basel))
    Niraparib induces resistance through the SP1-SE-SPHK1 axis, whereas Echinatin effectively reverses this mechanism by inhibiting the upstream regulator SP1, significantly potentiating the efficacy of Niraparib. This study reveals a novel molecular mechanism underlying Niraparib resistance and proposes a promising combination therapy strategy.
    Journal • BRCA Biomarker • PARP Biomarker
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    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • SPHK1 (Sphingosine Kinase 1)
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    Zejula (niraparib)
    8d
    Comparative Analysis of Maintenance Treatments in Patients with Newly Diagnosed Advanced Ovarian Cancer After First-Line Platinum-Based Regimens. (PubMed, Cancers (Basel))
    PARPi efficacy depends strongly on BRCA and HRD status. Olaparib-based regimens provide the greatest clinical benefit with acceptable safety in BRCA+ and HRD+ disease, whereas PARPi appear to be of limited value in HRD-negative ovarian cancer.
    Review • Journal • BRCA Biomarker • PARP Biomarker
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    BRCA (Breast cancer early onset)
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    HRD • BRCA mutation
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    Avastin (bevacizumab) • Lynparza (olaparib) • Zejula (niraparib) • Rubraca (rucaparib)
    9d
    Radiosensitization Effect of PARP Inhibitor Talazoparib Involves Decreasing Mitochondrial Membrane Potential and Induction of Cellular Senescence. (PubMed, Curr Issues Mol Biol)
    ER10 values for talazoparib, olaparib rucaparib, ABT888 and niraparib were 1.5, 1.8, 2.8, 1.4, and 1.4, respectively. When the p21 gene was knocked down, both the decrease in mitochondrial membrane potential and senescence level were attenuated, suggesting that p21 is involved in senescence induction after γ-irradiation combined with talazoparib treatment. Taken together, we showed that PARP inhibitor talazoparib treatment in combination with γ-irradiation causes cellular senescence in lung cancer cells, involving p21 function.
    Journal
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    CDKN1A (Cyclin-dependent kinase inhibitor 1A)
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    Lynparza (olaparib) • Talzenna (talazoparib) • Zejula (niraparib) • Rubraca (rucaparib) • veliparib (ABT-888)
    15d
    PARPi and myeloid neoplasms; the Italian MITO-MaNGO experience based on a multicentric survey. (PubMed, ESMO Open)
    While this survey is meant as hypotheses-generating, PrMN represent a rare but clinically relevant complication, particularly uncommon when PARPi are administered as first-line therapy. Their occurrence does not appear to be associated with the specific PARPi used or with BRCA mutation status. Early detection, monitoring, and identification of predictive factors are crucial as ovarian cancer outcomes improve and treatment exposure increases.
    Clinical • Journal • BRCA Biomarker • PARP Biomarker
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    BRCA (Breast cancer early onset)
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    BRCA mutation
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    Lynparza (olaparib) • Zejula (niraparib) • Rubraca (rucaparib)
    20d
    Claudin-4 as a dual regulator of genome stability and immune evasion in high grade serous ovarian cancer. (PubMed, Sci Rep)
    Dual targeting of claudin-4-expressing tumors with CMP and niraparib reshaped the tumor immune microenvironment, restoring TCR-zeta expression and promoting CD8 + T-cell infiltration, leading to improved anti-tumor efficacy of the PARP inhibitor niraparib. Our data show that claudin-4 orchestrates tumor immune evasion and survival, positioning it as a dual regulator of genome stability and immune escape, and highlighting it as a promising therapeutic target in ovarian cancer.
    Journal • PARP Biomarker
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    CD8 (cluster of differentiation 8)
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    Zejula (niraparib)
    20d
    TRIO-US L-06t: Niraparib, Temozolomide and Atezolizumab in Treating Patients With Advanced Solid Tumors and Extensive-Stage Small Cell Lung Cancer With a Complete or Partial Response to Platinum-Based First-Line Chemotherapy (clinicaltrials.gov)
    P1/2, N=59, Active, not recruiting, Jonsson Comprehensive Cancer Center | Suspended --> Active, not recruiting
    Enrollment closed
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    Tecentriq (atezolizumab) • temozolomide • Zejula (niraparib)
    22d
    The Real-World Impact of PARP Inhibitor Maintenance Therapy in High Grade Serous Tubo-Ovarian and Peritoneal Cancers. (PubMed, Cancers (Basel))
    BRCA2 germline-mutated patients obtained significantly greater benefit from olaparib compared to BRCA1-mutated patients. PFS benefit from niraparib (primary or recurrent setting) is comparable to clinical trials. There was no difference in benefit between niraparib and rucaparib in the recurrent setting.
    Journal • Real-world evidence • BRCA Biomarker • PARP Biomarker
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    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
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    HRD • BRCA wild-type • BRCA mutation
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    Lynparza (olaparib) • Zejula (niraparib) • Rubraca (rucaparib)