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

IMbrella B: A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (clinicaltrials.gov) - P3 | N=1000 | Recruiting | Sponsor: Hoffmann-La Roche | Phase classification: P4 ➔ P3

Phase classification • Oncology

IMbrella B: A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (clinicaltrials.gov) - P4 | N=1000 | Recruiting | Sponsor: Hoffmann-La Roche | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology

IMbrella B: A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (clinicaltrials.gov) - P4 | N=1000 | Not yet recruiting | Sponsor: Hoffmann-La Roche

New P4 trial • Oncology

IMbrella B: A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (clinicaltrials.gov) - P4 | N=1000 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Dec 2028 ➔ Jul 2028 | Trial primary completion date: Dec 2028 ➔ Jul 2028

Trial completion date • Trial primary completion date • Oncology

IMbrella B: A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (clinicaltrials.gov) - P3 | N=1000 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Recruiting ➔ Active, not recruiting

Enrollment closed • Oncology

Niraparib in Patients With Pancreatic Cancer (clinicaltrials.gov) - P2 | N=32 | Completed | Sponsor: Dana-Farber Cancer Institute | Active, not recruiting ➔ Completed

Trial completion • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • ATM • BRCA1 • BRCA2 • CHEK2

QUEST: A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P2 | N=136 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CTCs

Phase I study of niraparib with radiotherapy for treatment of metastatic and locally advanced invasive carcinoma of the cervix (NIVIX). (PubMed, Front Oncol) - "Treatment-limiting grade 2 thrombocytopenia occurred in patients with identifiable risk factors including low baseline platelet counts, hepatic dysfunction, and low body weight. These hypothesis-generating findings support further investigation with attention to patient selection criteria in future trials combining PARP inhibitors with radiotherapy."

Journal • P1 data • Cervical Cancer • Hepatology • Human Immunodeficiency Virus • Immunology • Infectious Disease • Liver Failure • Solid Tumor • Thrombocytopenia

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

FIRST/ENGOT-OV44 trial: Does the addition of dostarlimab (dost) impact niraparib (nira) tolerability, exposure, or dose modification? (ESMO 2025) - P3 | "The FIRST/ENGOT-OV44 trial (NCT03602859) investigated the addition of dost to 1L platinum-based chemotherapy (PBCT) and nira MT ± bevacizumab (bev). a Among pts who received nira MT. b Thrombocytopenia and anemia include selected preferred terms in the same medical concept, mapped through standardized MedDRA queries."

Oncology • Ovarian Cancer • Solid Tumor

A Phase 2 Trial of Niraparib in Patients with Advanced Pancreatic Cancer Harboring Pathogenic Variants in ATM, BRCA1, BRCA2, PALB2, and CHEK2. (PubMed, Clin Cancer Res) - P2 | "Niraparib demonstrated clinically meaningful benefit in a subset of patients. The prolonged PFS observed in patients with biallelic ATM loss warrants further investigation."

Journal • P2 data • Oncology • Pancreatic Cancer • Solid Tumor • ATM • BRCA1 • BRCA2 • CHEK2 • PALB2

A Randomized Phase 3 Study of Niraparib Plus Pembrolizumab as Maintenance Therapy for Advanced/Metastatic NSCLC: ZEAL-1L (IASLC-WCLC 2025) - "Niraparib failed to improve BICR-assessed PFS in the CR/PR population; no efficacy benefit was detected in key secondary endpoints."

Clinical • Metastases • P3 data • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Ovarian Cancer • Pneumonia • Pulmonary Embolism • Respiratory Diseases • Solid Tumor

3D-response and multiomic correlates of niraparib in relapsed mesothelioma: NERO, a randomised clinical trial in patients with relapsed mesothelioma (ESMO 2025) - P2 | "WSE low , not significant , HR 1.40, 95%CI 0.55-3.6, p=0.482. Conclusions In NERO, ITH predicted PARP inhibitor efficacy and NK cell immune activation."

Clinical • Late-breaking abstract • Tumor mutational burden • Mesothelioma • Oncology • Solid Tumor • STING • TMB

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

TESTING REPURPOSED DRUGS FROM THE ILCT PROGRAMME TO SPEED UP POTENTIAL TRANSLATION TO THE CLINIC (ADPD 2026) - "For example, Incyclinide and Niraparib increase mitophagy as well as decreasing lysosomal number. For this study we use patient dopaminergic neurons (iDANs) reprogrammed from primary fibroblasts... As the compounds have effects on different aspects of PD pathology, we next will move to investigating the additive potential of these compounds in this patient derived neuronal system, with the goal to speed up new compounds in the clinical trial for PD."

CNS Disorders • Movement Disorders • Parkinson's Disease • LRRK2 • SNCA

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

Niraparib and Abiraterone Acetate plus Prednisone in Metastatic Castration-resistant Prostate Cancer: Final Overall Survival Analysis for the Phase 3 MAGNITUDE Trial. (PubMed, Eur Urol Oncol) - "The MAGNITUDE final analysis showed that patients with HRR+ mCRPC, including those with the approved indication of BRCA-altered mCRPC, generally continue to benefit from first-line treatment with niraparib + AAP in comparison to placebo + AAP."

Journal • P3 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hematological Disorders • Oncology • Prostate Cancer • Solid Tumor • BRCA • BRCA1 • BRCA2 • HRD

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

Overcoming acquired doxorubicin resistance of ovarian carcinoma cells by verapamil‑mediated promotion of DNA damage‑driven cytotoxicity. (PubMed, Int J Oncol) - "A2780ADR cells revealed cross‑resistance to multiple compounds, including anticancer drugs [cisplatin (CisPt) and etoposide (Eto)] and DNA repair/DNA damage response (DDR) inhibitors (olaparib, niraparib, entinostat, prexasertib and rabusertib). However, combination treatment with Doxo and Ver also increased the cytotoxic response of non‑malignant murine cardiomyocytes, murine embryonic stem cells and human induced pluripotent stem cells. Taken together, the present study suggested inhibition of MDR1‑mediated Doxo efflux by Ver a useful approach to overcome acquired drug resistance of A2780ADR cells by stimulating DDR‑related cytotoxicity, yet at the price of a potentially increased risk of normal tissue toxicity."

Journal • Oncology • Ovarian Cancer • Solid Tumor • ABCB1 • RAC1

Pembrolizumab lenvatinib in metastatic uterine carcinosarcoma cohort : safety and efficacy from the french multicenter early access program subgroup (LARENA study) (ESGO 2026) - P2/3 | "Introduction/Background Uterine carcinosarcoma (UCS) is a rare and aggressive histological subtype of endometrial cancer, characterized by poor prognosis and limited response to chemotherapy. No specific safety signal was observed. Alternative studies with PARP inhibitor and immunotherapy are ongoing, including a phase II/III ROCSAN comparing dostarlimab–niraparib, niraparib alone, and chemotherapy in mUCS (NCT 03651206)."

Clinical • IO biomarker • Metastases • Carcinosarcoma • Endometrial Cancer • Microsatellite Instability • Oncology • Sarcoma • Solid Tumor • Uterine Cancer • MSI • TP53

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

Real-world effectiveness of systemic therapies after 177Lu]Lu-PSMA-617 (177Lu-PSMA-617) treatment in patients with metastatic castration-resistant prostate cancer (mCRPC): A prostate cancer disease observation (PRECISION) data platform analysis. (ASCO-GU 2026) - "Systemic therapies included ARPIs (abiraterone, enzalutamide, darolutamide, apalutamide); chemotherapy (cabazitaxel, docetaxel, carboplatin, cisplatin, etoposide, mitoxantrone); immunotherapy (pembrolizumab, sipuleucel-T); poly (ADP-ribose) polymerase (PARP) inhibitors (niraparib, olaparib, talazoparib, rucaparib); and radium-223. In this real-world analysis, meaningful clinical responses were observed in a subset of patients who received subsequent systemic therapies after 177Lu-PSMA-617."

Clinical • Metastases • Real-world • Real-world effectiveness • Real-world evidence • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

MAMMOTH: A Study of Azenosertib (ZN-c3) and Niraparib in Subjects With Platinum-Resistant Ovarian Cancer (clinicaltrials.gov) - P1/2 | N=117 | Completed | Sponsor: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc | Active, not recruiting ➔ Completed | Trial completion date: May 2025 ➔ Jan 2026 | Trial primary completion date: May 2025 ➔ Oct 2025

Monotherapy • Platinum resistant • Trial completion • Trial completion date • Trial primary completion date • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Niraparib (NIRA) and abiraterone acetate plus prednisone (AAP) in Chinese patients with breast cancer susceptibility gene (BRCA) altered metastatic castration-sensitive prostate cancer (mCSPC): Subgroup analysis of the phase III AMPLITUDE trial (ESMO Asia 2025) - P3 | "The Chinese BRCA-positive subgroup are consistent with those reported in the overall population of the AMPLITUDE trial, supporting the utility of early genomic testing and the incorporation of NIRA+AAP as a targeted therapeutic approach for Chinese patients with BRCA gene-altered mCSPC."

Clinical • Metastases • P3 data • Breast Cancer • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • BRCA • BRCA1 • BRCA2 • HRD

Discovery of dihydrospiro[cyclopropane-1,7'-pyrrolo[3,4-d]pyrimidine] derivatives as novel ATR inhibitors. (PubMed, RSC Med Chem) - "Pairwise drug combinational antiproliferative assays revealed that 10h and niraparib synergistically enhanced antiproliferative effects against Granta-519. These results suggested that 10h holds promise for further development as a lead compound for the design of ATR kinase-targeted therapies."

Journal • Ataxia • Immunology • Movement Disorders • Oncology • Primary Immunodeficiency • CHEK1