Zejula (niraparib) / Medison, GSK, ZAI Lab, J&J, Takeda - LARVOL DELTA

Comparative Pharmacovigilance Analysis of Safety Signals Among Advanced Prostate Cancer Therapies Using FAERS (FDA Adverse Event Reporting System). (PubMed, Curr Oncol) - "A retrospective pharmacovigilance study of FAERS reports evaluated enzalutamide, darolutamide, apalutamide, abiraterone acetate, relugolix, niraparib/abiraterone, talazoparib, rucaparib, cabazitaxel, sipuleucel-T, and lutetium-177 vipivotide. The absence of a detected signal should not be interpreted as evidence of safety or equivalence, as reporting volume, detection bias, and statistical power varied across therapies. Overall, the therapies demonstrated distinct toxicity profiles, which may inform treatment selection, toxicity monitoring, and patient counseling."

Adverse events • Clinical • Journal • Retrospective data • Gastroenterology • Gastrointestinal Disorder • Genito-urinary Cancer • Hematological Disorders • Oncology • Prostate Cancer • Solid Tumor

Early chemo-induced TME alterations as a predictor of response to PD-1 blockade in AVPC: Single-cell data from C3NIRA. (ASCO 2026) - P2 | "The C-COLA study (NCT03263650) showed that Cabazitaxel/Carboplatin (CabCarb) elicited inflammatory signaling in responsive patients with AVPC...Sixty patients completed induction and were subsequently randomized to Niraparib maintenance with or without Cetrelimab... One cycle of CabCarb induction altered the TME in a subset of AVPC tumors, with reduction of suppressive myeloid and T cell populations and expansion of anti-tumor effector cells associated with clinical responses. These early TME changes may predict benefit from the addition of PD-1 blockade and help refine patient selection for immune checkpoint inhibition. Ongoing analyses are identifying additional therapeutic vulnerabilities in the TME that can be targeted to further improve outcomes in men with AVPC."

Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CD4 • CD8 • FOXP3 • GZMK • LAG3 • SPP1 • TIGIT

C3NIRA: Randomized phase II study of carboplatin-cabazitaxel-cetrelimab (anti-PD-1) induction followed by niraparib +/- cetrelimab maintenance in men with aggressive variant prostate cancers (AVPC). (ASCO 2025) - P2 | "Most were White/non-Hispanic (78%) and had not received prior docetaxel (58%). A subset of men with AVPC derive meaningful benefit from the addition of anti-PD-1 to PARP inhibitor maintenance following platinum-taxane-anti-PD-1 induction. Ongoing correlates aim to identify biomarkers to select patients for this treatment strategy and reveal candidate mechanisms of resistance to guide future therapeutic combinations."

Clinical • IO biomarker • P2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CD8 • FOXP3

TBCRC 056: A phase II study of neoadjuvant niraparib with dostarlimab for patients with BRCA- or PALB2-mutated breast cancer: Results from the ER+/HER2- cohort. (SABCS 2024) - "Further data from the TNBC cohort of this study are awaited. Given the reported activity of PD-1 inhibitors in the preoperative management of HR+ breast cancer, additional exploration of targeted non-chemotherapy approaches is of great interest in this pt population."

Clinical • IO biomarker • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA • BRCA1 • BRCA2 • CD8 • ER • HER-2 • PALB2

Phase 2 randomized study of high-risk metachronous oligometastatic prostate cancer with high-risk mutations treated with metastasis-directed therapy and niraparib/abiraterone acetate plus prednisone (KNIGHTS) trial. (ASCO-GU 2025) - P2 | "Secondary endpoints will include toxicity, health-related quality of life (HRQoL), time to locoregional progression, time to distant progression, time to new metastasis, radiographic progression-free survival, and duration of response. Discovery correlatives associated with clinical outcome will be assessed by collection of including, but not limited to, cell free DNA, circulating-tumor cells, immunologic biomarkers, microbiota and radiomics."

Clinical • Metastases • P2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • BRCA1 • BRCA2 • BRIP1 • CHEK2 • CTCs • FANCA • MUTYH • PALB2 • RAD51B • RAD54L • RB1 • TP53

Circulating tumor DNA surveillance in ZEST, a randomized, phase 3, double-blind study of niraparib or placebo in patients w/ triple-negative breast cancer or HER2+ BRCA-mutated breast cancer with molecular residual disease after definitive therapy. (SABCS 2024) - "The ZEST study was terminated early because of infeasibility of completing enrollment due to a low rate of ctDNA+ and a high rate of metastatic disease at the time of ctDNA+. Although ctDNA testing began any time after EODT, ctDNA+ occurred most frequently on the first test and ≤6 months from EODT. Pts, predominantly those with TNBC, had a high rate of radiographic recurrence at time of ctDNA+, consistent with early recurrence typical of TNBC."

Circulating tumor DNA • Clinical • P3 data • Residual disease • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA • HER-2

Niraparib plus abiraterone acetate with prednisone in patients with metastatic castration-resistant prostate cancer and homologous recombination repair gene alterations: second interim analysis of the randomized phase III MAGNITUDE trial. (PubMed, Ann Oncol) - "MAGNITUDE, enrolling the largest BRCA1/2 cohort in first-line mCRPC to date, demonstrated improved rPFS and other clinically relevant outcomes with niraparib plus AAP in patients with BRCA1/2-altered mCRPC, emphasizing the importance of identifying this molecular subset of patients."

Journal • Metastases • P3 data • P3 data: top line • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • BRCA • BRCA1 • BRCA2 • HRD

Exposure-response relationship of niraparib in maintenance therapy for recurrent ovarian cancer: ancillary analysis of the French GINECO-NiQoLe study. (PubMed, ESMO Open) - "Increased plasma exposure at D8 (Cmin,ss ≥686 ng/ml) was associated with a higher risk of early DLT onset and patient-reported outcomes adverse events, without gain of efficacy in regard to PFS. Early plasma drug monitoring may be useful to prevent niraparib toxicity in patients with ROC treated in the maintenance phase."

Journal • Fatigue • Oncology • Ovarian Cancer • Solid Tumor

Sustainable and efficient platform trial of new therapeutic development for early breast cancer (JCOG2205: S-FACT trial) (ESMO 2025) - P2 | "One TN cohort has already been initiated: Carboplatin plus paclitaxel plus pembrolizumab followed by niraparib plus pembrolizumab. Postoperative follow-up will be conducted as an accompanying observational study to evaluate prognosis, including invasive disease-free survival and overall survival."

Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

Heterocyclic Scaffolds in PARP-1 Inhibition: An Emerging Strategy for Targeted Anticancer Therapy. (PubMed, Mini Rev Med Chem) - "Heterocyclic scaffolds offer a promising route toward next-generation PARP-1 inhibitors with enhanced efficacy, reduced resistance, and optimized safety, supporting personalized anticancer therapy."

Journal • Hematological Disorders • Oncology • BRCA • HRD • PARP2

Addition of Niraparib to Best Supportive Care as Maintenance Treatment in Patients with Advanced Urothelial Carcinoma Whose Disease Did Not Progress After First-line Platinum-based Chemotherapy: The Meet-URO12 Randomized Phase 2 Trial. (PubMed, Eur Urol) - "Addition of maintenance niraparib to BSC after first-line PBCT did not demonstrate a significant improvement in PFS in patients with UC. These results do not support the conduction of a phase 3 trial with single agent niraparib in this population."

Journal • P2 data • Constipation • Fatigue • Gastroenterology • Gastrointestinal Disorder • Genito-urinary Cancer • Hematological Disorders • Mucositis • Neutropenia • Oncology • Solid Tumor • Thrombocytopenia • Urothelial Cancer

Patient (pt) reported outcomes (PROs) from AMPLITUDE, a randomized placebo-controlled phase III trial of niraparib (NIRA) and abiraterone acetate (AA) plus prednisone (P) in metastatic hormone-sensitive prostate cancer (mHSPC) with homologous recombination repair mutations (HRRm) (ESMO 2025) - P3 | "Methods Pts with HRRm mHSPC (≤6 mo androgen deprivation therapy, ± ≤6 cycles docetaxel, ± ≤45 d AA + P allowed as prior treatments [tmt]) were randomized 1:1 to receive dual-action tablet (NIRA 200 mg + AA 1000 mg) plus P 5 mg PO QD or placebo + AA + P QD in 28 d cycles. Time to progression in BPI-SF worse pain intensity score was not different between arms (HR 0.95; 95% CI 0.72-1.26; p=0.7) and the medians were not reached. Conclusions In HRRm mHSPC, NIRA + AA + P maintained BL HRQoL with no clinically meaningful changes while significantly improving rPFS vs AA + P."

Clinical • Late-breaking abstract • Metastases • P3 data • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • HRD

Phase 3 AMPLITUDE trial: Niraparib (NIRA) and abiraterone acetate plus prednisone (AAP) for metastatic castration-sensitive prostate cancer (mCSPC) patients (pts) with alterations in homologous recombination repair (HRR) genes. (ASCO 2025) - P3 | "Eligible pts had received ≤6 mo of androgen deprivation therapy (ADT) ± ≤6 cycles of docetaxel (DOC) ± ≤45 d of AAP with metastatic disease extended beyond lymph nodes. NIRA + AAP significantly improved rPFS and TSP vs AAP in pts receiving ADT +/- prior DOC and had a favorable effect on OS. There were no new safety signals. AMPLITUDE supports NIRA + AAP as a potential new standard of care for pts with HRR gene–altered mCSPC."

Clinical • Late-breaking abstract • Metastases • P3 data • Anemia • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Hypertension • Oncology • Prostate Cancer • Solid Tumor • BRCA1 • BRCA2 • BRIP1 • CDK12 • CHEK2 • FANCA • HRD • PALB2 • RAD51B • RAD54L

Dostarlimab plus chemotherapy followed by dostarlimab plus niraparib maintenance therapy among patients with primary advanced or recurrent endometrial cancer in the ENGOT-EN6-NSGO/GOG-3031/RUBY trial (SGO 2024) - P3 | "Objectives: In Part 1 of the phase 3 RUBY trial (NCT03981796) of patients (pts) with primary advanced or recurrent endometrial cancer (pA/rEC), pts receiving dostarlimab (an immune-checkpoint inhibitor) + carboplatin-paclitaxel (CP) exhibited significant benefits in progression-free survival (PFS) and overall survival versus CP alone. Data analysis will be presented at the annual meeting.."

Clinical • Late-breaking abstract • Metastases • Endometrial Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI

Niraparib plus nivolumab or niraparib plus ipilimumab in patients with platinum-sensitive advanced pancreatic cancer: a randomised, phase 1b/2 trial. (PubMed, Lancet Oncol) - P1b/2 | "The primary endpoint of 6-month progression-free survival was met in the niraparib plus ipilimumab maintenance group, whereas niraparib plus nivolumab yielded inferior progression-free survival. These findings highlight the potential for non-cytotoxic maintenance therapies in patients with advanced pancreatic cancer."

Journal • P1/2 data • Cardiovascular • Fatigue • Gastrointestinal Cancer • Hematological Disorders • Hepatology • Hypertension • Immune Modulation • Inflammation • Oncology • Pancreatic Cancer • Solid Tumor • Thrombocytopenia

TBCRC 050: A phase 1b/2 trial of niraparib and trastuzumab in HER2-positive metastatic breast cancer (MBC): Efficacy and correlative analyses. (ASCO 2026) - P1/2 | "Pts were heavily pretreated (median 3 prior regimens), including trastuzumab deruxtecan in 22 pts; 33% had brain metastases. Niraparib plus trastuzumab demonstrated a favorable safety profile and durable clinical benefit in heavily pretreated HER2+ MBC. Integrated tumor and blood-based analyses identify immune-organized tumor microenvironments and systemic immune normalization as key correlates of prolonged response, supporting further investigation of PARP inhibition strategies."

Clinical • Metastases • P1/2 data • Breast Cancer • CNS Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • BRCA • BRCA1 • BRCA2 • HER-2

Niraparib in patients with BRCA-mutated unresectable or recurrent biliary tract, pancreatic and other gastrointestinal cancers: An investigator-initiated phase 2 trial (NIR-B trial). (ASCO-GI 2025) - P2 | "Although niraparib had signs of clinical activity in pts with BRCA-mutated BTC and PC, the primary endpoint was not achieved statistically. No new safety signal was observed. Alternative approaches, such as evaluation in biomarker-selected patients or in combination with other agents, may demonstrate greater clinical activity of niraparib in this setting."

Clinical • P2 data • Biliary Cancer • Biliary Tract Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • BRCA • BRCA1 • BRCA2 • HRD

Feasibility and outcome of genomics-guided treatment selection in advanced cancer - the MEGALiT explorative clinical trial. (PubMed, Acta Oncol) - "Genomics-guided treatment selection in advanced cancer is feasible and safe. However, evidence of patient benefit warrants further investigation."

Biomarker • Journal • Oncology • Ovarian Cancer • Solid Tumor

Patient-reported Outcomes for Patients with Metastatic Castration-resistant Prostate Cancer and BRCA1/2 Gene Alterations: Final Analysis from the Randomized Phase 3 MAGNITUDE Trial. (PubMed, Eur Urol) - P3 | "Treatment with niraparib + AAP maintained HRQoL with minimal side-effect bother reported by most patients with BRCA+ mCRPC. Differences between treatment groups in time to pain deterioration did not meet conventional levels of statistical significance. The MAGNITUDE trial is registered on ClinicalTrials.gov as NCT03748641."

Journal • Metastases • P3 data • Patient reported outcomes • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Pain • Prostate Cancer • Solid Tumor • BRCA • BRCA1 • BRCA2 • HRD

REAL-WORLD SAFETY AND EFFICACY OF NIRAPARIB MAINTENANCE THERAPY IN JAPANESE PATIENTS WITH PLATINUM -SENSITIVE RECURRENT OVARIAN CANCER: JGOG3031 COHORT 1 (IGCS 2026) - "Median observation period was 32.9 months. Median age was 65.0 years, 79.7% had high-grade serous carcinoma. Treatment lines were 2nd-line (54.1%), 3rd-line (31.4%), ≥4th-line (14.5%)."

Clinical • Platinum sensitive • Real-world • Real-world evidence • Fallopian Tube Cancer • Hematological Malignancies • Myelodysplastic Syndrome • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • BRCA

Atezolizumab Combined With Platinum and Maintenance Niraparib for Recurrent Ovarian Cancer With a Platinum-Free Interval >6 Months: ENGOT-OV41/GEICO 69-O/ANITA Phase III Trial. (PubMed, J Clin Oncol) - P3 | "Combining atezolizumab with CT and maintenance niraparib for late-relapsing recurrent ovarian cancer did not significantly improve PFS or the ORR."

IO biomarker • Journal • P3 data • Oncology • Ovarian Cancer • Solid Tumor • BRCA • PD-L1

Phase 3 MAGNITUDE study: First results of niraparib (NIRA) with abiraterone acetate and prednisone (AAP) as first-line therapy in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) with and without homologous recombination repair (HRR) gene alterations. (ASCO-GU 2022) - P3 | "NIRA + AAP improves rPFS and other clinically relevant outcomes in pts with mCRPC and alterations in HRR associated genes."

Clinical • P3 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • AR • BRCA1 • BRCA2 • BRIP1 • CDK12 • CHEK2 • FANCA • HDAC2 • HRD • PALB2

Gliofocus: a global randomized phase 3 trial evaluating niraparib versus temozolomide with radiotherapy in newly diagnosed MGMT-unmethylated glioblastoma (EANO 2026) - P3 | "The trial is sponsored by the Ivy Brain Tumor Center with funding/product support from GSK. GSK was provided the opportunity to provide a courtesy review of the abstract; however, the authors are solely responsible for final content."

Clinical • P3 data • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • MGMT

Maintenance of PARP Inhibitor Rechallenge Plus Bevacizumab in Patients with Platinum-Sensitive, Recurrent Ovarian Cancer Previously Treated with a PARP Inhibitor. (PubMed, Clin Cancer Res) - "This is the first report of PARPi rechallenge with bevacizumab as maintenance therapy in this setting. The combination demonstrated promising efficacy, particularly in patients with favorable platinum responsiveness, and warrants further investigation in biomarker-driven studies."

Journal • Platinum sensitive • Oncology • Ovarian Cancer • Solid Tumor

FIRST/ENGOT-OV44: A phase 3 clinical trial of dostarlimab (dost) and niraparib (nira) in first-line (1L) advanced ovarian cancer (aOC). (ASCO 2025) - P3 | "Clinical Trial Registration Number: NCT03602859 Background: The FIRST/ENGOT-OV44 trial evaluated adding dost, a programmed cell death protein-1 inhibitor, to 1L platinum-based chemotherapy (PBCT) and nira maintenance (MT) ± bevacizumab (bev) in patients (pts) with aOC. Adding dost to 1L PBCT and nira MT ± bev improved PFS in pts with aOC. No OS difference was observed."

Clinical • IO biomarker • Late-breaking abstract • Metastases • P3 data • Oncology • Ovarian Cancer • Solid Tumor • BRCA • HRD • PD-L1