AiRuiYi (fluzoparib) / Jiangsu Hengrui Pharma - LARVOL DELTA

Neoadjuvant long-course chemoradiotherapy (LCCRT) followed by fuzuloparib and capecitabine in locally advanced rectal cancer: Results from a phase 2 study (ESMO 2026) - No abstract available

Clinical • Metastases • P2 data • Colorectal Cancer • Oncology • Rectal Cancer • Solid Tumor

Fuzuloparib combined with abiraterone acetate and prednisone (AA-P) as first-line (1L) treatment for metastatic castration-resistant prostate cancer (mCRPC): Interim results from the FUZUPRO trial. (ASCO 2026) - P3 | "Fuzuloparib plus AA-P as 1L treatment significantly prolonged rPFS in patients with mCRPC. The combination showed acceptable safety and tolerability with no new safety signals identified. NR, not reached."

Clinical • Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • BRCA1 • BRCA2 • DRD

Fuzuloparib with or without apatinib in HER2- metastatic breast cancer (mBC) patients (pts) with germline BRCA1/2 mutations (gBRCA1/2m): A randomized phase III trial (ESMO Plenary May 2024) - P3 | "Clinical trial identification NCT04296370"

Clinical • Metastases • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • BRCA1 • BRCA2 • HER-2

SHR-1701 combined with fuzuloparib and chemotherapy as first-line therapy for advanced lung squamous cell carcinoma: Efficacy and safety results from a phase II study. (ASCO 2026) - P2 | "SHR-1701 plus fuzuloparib and chemotherapy as first-line therapy demonstrated promising anti-tumor activity and a manageable safety profile in patients with advanced LUSC."

Clinical • IO biomarker • Metastases • P2 data • Hematological Disorders • Non Small Cell Lung Cancer • Oncology • Renal Disease • TGFB1

Fuzuloparib with or without apatinib in patients with HER2-negative metastatic breast cancer with germline BRCA1/2 mutations (FABULOUS): interim analysis of a multicentre, three-arm, open-label, randomised, phase 3 trial. (PubMed, Lancet Oncol) - P3 | "Fuzuloparib, either as monotherapy or in combination with apatinib, provided statistically significant improvements in progression-free survival compared with chemotherapy in patients with HER2-negative metastatic breast cancer with germline BRCA1/2 mutations, presenting as new treatment options."

Clinical • Journal • P3 data • P3 data: top line • Breast Cancer • Cardiovascular • Hematological Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hypertension • Oncology • Septic Shock • Solid Tumor • BRCA1 • BRCA2 • HER-2

Fuzuloparib (FZPL) monotherapy or in combination with apatinib (APA) as first-line (1L) maintenance therapy in advanced ovarian cancer (OC): Final analysis of the FZOCUS-1 trial (ESMO 2025) - P3 | "Grade >=3 TRAEs (mostly hematologic) were reported by 48.7%, 45.7%, and 7.4% of pts in the FZPL+APA, FZPL, and placebo group. Table: 1063O Efficacy summary FZPL+APA (N = 269) FZPL (N = 269) Placebo (N = 136) Overall population mPFS, mo (95% CI) 26.9 (20.3, 36.6) 29.9 (22.1, 36.1) 11.1 (8.3, 16.6) HR, vs placebo (95% CI) 0.57 (0.44, 0.75) 0.58 (0.44, 0.75) HR, vs FZPL (95% CI) 1.04 (0.83, 1.32) HRD, including BRCAm (n=486) mPFS, mo (95% CI) 34.1 (22.4, 41.2) 35.8 (27.3, NR) 16.6 (8.3, 31.1) HR, vs placebo (95% CI) 0.67 (0.48, 0.93) 0.62 (0.45, 0.87) HR, vs FZPL (95% CI) 1.09 (0.83, 1.44) HRP (n=118) mPFS, mo (95% CI) 16.6 (10.2, 22.1) 11.0 (6.5, 16.6) 5.5 (3.3, 13.8) HR, vs placebo (95% CI) 0.51 (0.30, 0.86) 0.68 (0.40, 1.15) HR, vs FZPL (95% CI) 0.73 (0.45, 1.19) Conclusions Adding antiangiogenic APA to FZPL did not enhance PFS among HRD pts in the 1L maintenance setting, while HRP pts showed PFS benefit trend with FZPL+APA compared to FZPL alone."

Clinical • Combination therapy • Metastases • Monotherapy • Oncology • Ovarian Cancer • Solid Tumor • BRCA • BRCA1 • BRCA2 • HRD

Fuzuloparib with or without apatinib in patients with HER2-negative metastatic breast cancer with germline BRCA1/2 mutations: a cost-utility analysis. (PubMed, Front Pharmacol) - "From the perspective of the Chinese healthcare system, both fuzuloparib plus apatinib and fuzuloparib monotherapy is cost-effective compared with standard chemotherapy at current WTP threshold. However, FA was not cost-effective relative to FM at the current Chinese WTP threshold."

HEOR • Journal • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • BRCA • BRCA1 • BRCA2 • HER-2

Retlirafusp Alfa Combined With Chemotherapy or Fuzuloparib for Triple-Negative Breast Cancer (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Harbin Medical University

New P2 trial • Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA1 • BRCA2 • ER • HER-2 • PGR

Fzp-MA-TNBC: A Single-Arm Phase ? Study of Fluzoparib Maintenance in Platinum-sensitive Advanced Triple-Negative Breast Cance (clinicaltrials.gov) - P2 | N=72 | Recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Platinum sensitive • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA • HER-2

FASCINATE-N: Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (clinicaltrials.gov) - P2 | N=716 | Recruiting | Sponsor: Fudan University | Trial completion date: Sep 2028 ➔ Sep 2029 | Trial primary completion date: Dec 2026 ➔ Dec 2027

Trial completion date • Trial primary completion date • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD8 • FOXC1 • HER-2 • PGR

Clinical Study on the Efficacy and Safety of Fluzoparib Combined with Famitinib as Maintenance Therapy after First-Line Platinum-Based Chemotherapy in HRD-Negative Advanced Ovarian Cancer (ChiCTR) - P2 | N=30 | Not yet recruiting | Sponsor: Yantai Yuhuangding Hospital; Yantai Yuhuangding Hospital

New P2 trial • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Solid Tumor • BRCA1 • BRCA2 • MUC16

Fluzoparib Combined With Camrelizumab for Neoadjuvant Treatment of Embryogenic BRCA Mutation HER2 Negative Breast Cancer: an Open, Single Arm, Multicenter Study (clinicaltrials.gov) - P2 | N=64 | Recruiting | Sponsor: Peking University People's Hospital | Enrolling by invitation ➔ Recruiting | N=94 ➔ 64 | Trial completion date: Dec 2026 ➔ Dec 2028 | Trial primary completion date: Apr 2024 ➔ Apr 2027

Enrollment change • Enrollment status • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Inflammatory Breast Cancer • Oncology • Solid Tumor • BRCA • BRCA1 • BRCA2 • HER-2

Cost-effectiveness of fuzuloparib, with or without apatinib, for BRCA mutation HER2-negative metastatic breast cancer in China. (PubMed, Front Pharmacol) - "Although fuzuloparib, with or without apatinib, has shown substantial clinical benefits, it has not proven to be cost-effective when compared to standard chemotherapy. Further global multicenter or population-specific clinical trials involving breast cancer patients are necessary to enhance the understanding of the application scope and cost-effectiveness of fuzuloparib."

HEOR • Journal • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • BRCA • HER-2

Synchronous primary breast invasive carcinoma and breast metastasis from high-grade serous ovarian carcinoma: a case report and literature review. (PubMed, Front Oncol) - "She received neoadjuvant paclitaxel plus carboplatin and achieved a partial response, followed by interval cytoreductive surgery, additional chemotherapy combined with bevacizumab, breast tumor excision, and maintenance therapy with fluzoparib plus bevacizumab. Morphology combined with an appropriate immunohistochemical panel is essential for distinguishing primary breast carcinoma from metastatic ovarian carcinoma. Multidisciplinary evaluation and genetic assessment should be considered in similar cases."

Journal • Breast Cancer • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Respiratory Diseases • Solid Tumor • Women's Health

Fluzoparib + Bevacizumab vs Olaparib + Bevacizumab for Maintenance Therapy in HRD-Positive Advanced Ovarian Cancer (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Shandong University

New P2 trial • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Solid Tumor • HRD

Pharmacokinetics, safety, and efficacy of fuzuloparib in combination with abiraterone acetate and prednisone in patients with metastatic castration-resistant prostate cancer: a phase 1 dose escalation and expansion study. (PubMed, BMC Cancer) - P1 | "Fuzuloparib plus AA-P had an acceptable safety profile and showed promising efficacy among mCRPC patients."

Journal • P1 data • PK/PD data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • BRCA • HRD

Liquid biopsy with peripheral blood mononuclear cells: Deciphering systemic immunity to predict PARPi-immunotherapy efficacy in early HER2-negative breast cancer. (ASCO 2026) - "We investigated whether PBMC-based immune profiling could predict pathological complete response (pCR) in patients with HER2-negative early breast cancer treated with the combination regimen of Nab-Paclitaxel, Camrelizumab (PD-1 inhibitor) and Fuzuloparib (PARP inhibitor). PBMC-based transcriptional profiling at baseline and during NAT is associated with response to neoadjuvant PARP inhibitor–immunotherapy and may provide a noninvasive approach to predict pCR in early HER2-negative breast cancer."

Biopsy • Clinical • IO biomarker • Liquid biopsy • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA1 • BRCA2 • CD4 • HER-2

PARP inhibitors in the treatment of ovarian cancer: a narrative review. (PubMed, Transl Cancer Res) - "It details the efficacy of major PARPis (olaparib, niraparib, rucaparib, and fuzuloparib) in pivotal trials. Overcoming resistance requires a multipronged approach integrating deep molecular profiling, mechanism-informed combination therapies, and biomarker-driven clinical trial designs. Future progress hinges on translating biological insights into personalized treatment strategies to extend durable remission for a greater portion of patients, while also addressing the economic and ethical implications of long-term maintenance therapy."

IO biomarker • Journal • Review • Oncology • Ovarian Cancer • Solid Tumor • HRD

Fuzuloparib enhances radiosensitivity of gain-of-function mutant p53 R273H NSCLC by promoting SLC7A11/GSH/GPX4 axis mediated ferroptosis. (PubMed, NPJ Precis Oncol) - "Whether mutant p53 R273H-mediated radioresistance is related to the interaction between mutant p53 R273H and PARP1, and if PARP1 inhibitors (PARPi) can increase the radiosensitivity of mutant p53 R273H-expressing tumors have not been explored. Through in vitro and in vivo experiments, we determined that mutant p53 R273H promotes radioresistance in NSCLC by partially inhibiting ferroptosis through the SLC7A11/GSH/GPX4 axis, independently of PARP1, whereas FZ counteracts this effect by partially blocking the same axis to promote ferroptosis, presenting a potential novel strategy for treating NSCLC patients with gain-of-function mutant p53 R273H."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • GPX4 • SLC7A11 • TP53

Expert Consensus on the Clinical Application of Poly ADP Ribose Polymerase Inhibitors in Breast Cancer (2025 Edition). (PubMed, Cancer Innov) - "Currently, PARP inhibitors such as Olaparib and Fluzoparib have been approved for clinical use. This consensus, based on the latest evidence-based medical data, provides guidance on the standardized application and safety management of PARP inhibitors in breast cancer treatment, aiming to serve as a reference for clinical practice."

Journal • Breast Cancer • Oncology • Solid Tumor • Women's Health • BRCA1 • BRCA2

Advancements in the manufacturing routes for the synthesis of marketed PARP inhibitors. (PubMed, RSC Adv) - "To date, seven PARP inhibitors have received marketing approval, namely, olaparib, rucaparib, niraparib, talazoparib, fuzuloparib, pamiparib and senaparib, in various countries. These modern approaches integrate key transformations, such as amide bond formation, C-H activation, carbopalladation, heterocycle construction, and stereocontrolled cyclisation, enabling improved efficiency and scalability. In parallel, the incorporation of green chemistry principles, particularly in one of the manufacturing routes of olaparib, has led to more sustainable process development."

Journal • Review • Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor

Expert consensus on the clinical application of PARP inhibitors in breast cancer (2025 edition) (PubMed, Zhonghua Zhong Liu Za Zhi) - "Currently, PARP inhibitors such as olaparib and fluzoparib have been approved for clinical use. Based on the latest evidence-based medical data, the Professional Committee on Clinical Research of Oncology Drugs, China Anti-Cancer Association, Expert Committee for Monitoring the Clinical Application of Antitumor Drugs and Breast Cancer Expert Committee of National Cancer Quality Control Center, Cancer Chemotherapy Quality Control Expert Committee of Beijing Cancer Treatment Quality Control and Improvement Center have jointly organized and invited domestic oncology experts with rich diagnosis and treatment experience as well as relevant interdisciplinary experts to compile the "Expert consensus on the clinical application of PARP inhibitors in breast cancer (2025 edition)". This consensus aims to provide guidance on the standardized application and safety management of PARP inhibitors in breast cancer treatment, with the goal of supporting clinical practice."

Journal • Breast Cancer • Oncology • Solid Tumor • Women's Health • BRCA1 • BRCA2

PARP Inhibitors and the Risk of Serum Creatinine Elevation in Ovarian Cancer: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. (PubMed, Cancers (Basel)) - "PARP inhibitors significantly increase the likelihood of SCr elevation in EOC; however, severe nephrotoxicity appears uncommon in RCTs. Observed SCr increases may partly reflect inhibition of renal tubular creatinine transport rather than true reductions in glomerular filtration. Careful renal monitoring and prospective studies incorporating direct GFR assessment are warranted."

Journal • Retrospective data • Review • Epithelial Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor

A Study on the Use of Fluzoparib Combined With Chemotherapy for Neoadjuvant Treatment of HRD-positive, HR+/HER2- Breast Cancer (clinicaltrials.gov) - P2 | N=28 | Completed | Sponsor: Xijing Hospital | Recruiting ➔ Completed | Trial completion date: Dec 2026 ➔ Mar 2026 | Trial primary completion date: Nov 2026 ➔ Feb 2026

Trial completion • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • BRCA • BRCA1 • BRCA2 • ER • HER-2 • HRD • PGR

A Study of Apatinib Combined With Letrozole With or Without Fluzoparib in Estrogen Receptor-Positive, Platinum-Sensitive Recurrent Ovarian Cancer Previously Treated With First-Line PARP Inhibitor (clinicaltrials.gov) - P=N/A | N=5 | Terminated | Sponsor: Peking Union Medical College Hospital | N=70 ➔ 5 | Trial completion date: Oct 2028 ➔ Mar 2026 | Not yet recruiting ➔ Terminated | Trial primary completion date: Oct 2027 ➔ Mar 2026; Results failed to achieve the anticipated effect.

Enrollment change • Platinum sensitive • Trial completion date • Trial primary completion date • Trial termination • Oncology • Ovarian Cancer • Solid Tumor • BRCA1 • BRCA2 • ER