AiRuiYi (fluzoparib)

Fluzoparib, the domestically developed PARPi in China, has demonstrated significant efficacy in BRCA-mutated ovarian cancer. In the field of supportive care, megestrol acetate (MA) is recommended as the first-line preferred therapeutic agent for cancer-related anorexia by major guidelines, though its role in first-line ovarian cancer therapy remains unexplored, and evidence for its combination with PARPi is lacking...Imaging assessments revealed significant tumor reduction without disease progression or grade ≥3 adverse events observed throughout follow-up. This case highlights the potential of combining PARPi and hormone therapy as a 'chemotherapy-free' precision treatment model for elderly and HRD-positive ovarian cancer patients, offering a promising strategy to balance efficacy and tolerability in a population traditionally underserved by conventional regimens.

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.

Although poly(adenosine diphosphate-ribose) polymerase inhibitors (PARPis) and bevacizumab were approved as first-line maintenance for advanced ovarian cancer (OC), evidence comparing this combination with PARPi monotherapy, especially in BRCA-mutated/homologous recombination-deficient (HRD) patients, is lacking. Adding apatinib to fuzuloparib did not prolong PFS among homologous recombination-deficient patients. There was a PFS benefit trend among homologous recombination-proficient patients who received combination therapy compared with those who received monotherapy.

This study aims to investigate the therapeutic potential of 131I-MIBG and the PARP inhibitor fluzoparib monotherapies and their combination on two distinct PC12-derived stable cell lines: PC12-NET cells and PC12-NET-SDHB cells...The specificity of PC12-NET cells to the 131I-MIBG was confirmed through desipramine inhibition assays...The combined of 131I-MIBG with PARP inhibitor demonstrated a synergistic antitumor effect in PC12-NET cells. While PC12-NET-SDHB cells display comparable sensitivity to 131I-MIBG as PC12-NET cells, they exhibited heightened responsiveness to PARP inhibitor treatment.

[18F]Fuzuloparib showed high tumor accumulation (peak 9.06 ± 0.31 %ID/g at 2 h) and sustained intratumoral retention (7.12 ± 0.31 %ID/g at 6 h), underscoring its potential as a promising PET imaging agent. These preclinical findings highlight the potential of [18F]Fuzuloparib as a robust non-invasive imaging agent for identifying PARP-overexpressing malignancies, with implications for optimizing PARP inhibitor therapy and forecasting therapeutic response.

P=N/A, N=30, Not yet recruiting, Harbin Medical University Affiliated Cancer Hospital; Harbin Medical University Affiliated Cancer Hospital

The patient achieved a remarkably prolonged progression-free survival (PFS) of 37 months on this combination therapy, representing the longest period of disease control in her metastatic course. Although eventual progression occurred (new axillary lymph node metastasis and suspected hepatic recurrence), this case demonstrates the exceptional efficacy and durable disease control achievable with Fluzoparib plus Exemestane in a pretreated patient with gBRCA2-mutated HR+/HER2-advanced breast cancer, highlighting a promising therapeutic approach for this molecularly defined population.

Despite showing improved efficacy and a more favorable safety profile compared to olaparib in preclinical studies, clinical evidence for its application in pancreatic adenocarcinoma harboring gBRCAm remains limited...This case underscores the important role of biomarker-directed therapy in pancreatic adenocarcinoma and fuzuloparib may represent a potential PARP inhibitor option for maintenance treatment in pancreatic adenocarcinoma with gBRCAm. However, large-scale randomized controlled trials are needed to validate these results.

Following the discovery of a BRCA2 mutation, the PARP inhibitor fluzoparib was administered, which was associated with temporary disease stabilization...This case suggests that leveraging the tissue-sparing benefits of initial PBT may enable effective salvage SRS for managing residual or recurrent high-grade pediatric astroblastoma. Furthermore, it highlights the potential role of molecular profiling to guide targeted therapies in these rare tumors.

P2, N=28, Recruiting, Xijing Hospital

P1/2, N=100, Not yet recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

P2, N=716, Recruiting, Fudan University | Trial completion date: Sep 2025 --> Sep 2028 | Trial primary completion date: Dec 2024 --> Dec 2026