Safety and effectiveness of fuzuloparib in patients with ovarian cancer: A nationwide, multicenter, prospective real-world study.

5572 Background: Fuzuloparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, is approved in China for the treatment of platinum-sensitive recurrent (PSR) ovarian cancer (OC) and for maintenance therapy in newly diagnosed advanced and PSR OC. This study aims to evaluate the safety and effectiveness of fuzuloparib in OC patients under real-world settings. Methods: This multicenter, prospective real-world study included patients from 27 centers across China between January 2022 and August 2024. Eligible patients were aged ≥18 years and suitable for fuzuloparib treatment (monotherapy or combination therapy). Patients also had histologically or cytologically confirmed epithelial OC, primary peritoneal or fallopian tube cancer. The outcomes observed in this study included the incidence of treatment-related adverse events (TRAEs), progression-free survival (PFS), and overall survival (OS). Results: A total of 260 patients who received fuzuloparib (171 on monotherapy, 66 on combination therapy, and 23 with unknown treatment type) were analyzed. Of these, 97 (37.3%) received first-line maintenance therapy, 112 (43.1%) received maintenance therapy for PSR disease, 23 (8.8%) received treatment for PSR disease, 20 (7.7%) received treatment for platinum-resistant recurrent disease, and 8 (3.1%) received other treatments. The median age was 57 years (interquartile range [IQR]: 51.0, 65.0). Among the patients, 215 (82.7%) had epithelial OC, 169 (65.0%) were diagnosed at stage III/IV. Of the 239 patients with available safety data, 149 (62.3%) reported at least one TRAE. The most common TRAEs were anemia (23.4%), thrombocytopenia (23.4%), leukopenia (18.8%), and lymphopenia (12.6%). Fifty-four patients (22.6%) reported grade 3 or higher TRAEs. The median follow-up time for the first-line maintenance therapy group was 11.4 months (IQR: 6.0, 17.4), with median PFS and OS not yet reached; the 1-year PFS rate was 90.7%, and the 1-year OS rate was 97.1%. In the PSR maintenance therapy group, the median follow-up time was 9.1 months (IQR: 4.2, 15.9), with median PFS of 17.3 months (95% confidence interval [CI]: 12.1-26.3) and median OS not yet reached; the 1-year PFS rate was 66.2%, and the 1-year OS rate was 92.0%. In the PSR treatment group, the median follow-up time was 12.7 months (IQR: 5.6, 19.9), with median PFS and OS not yet reached; the 1-year PFS rate was 77.8%, and the 1-year OS rate was 90.2%. In the platinum-resistant relapse treatment group, the median follow-up time was 8.9 months (IQR: 5.1, 13.2), with median PFS and OS not yet reached; the 1-year PFS rate was 59.1%, and the 1-year OS rate was 80.0%. Conclusions: This is the first large-scale real-world study assessing the safety and effectiveness of fuzuloparib. In the real-world setting, fuzuloparib shows favorable safety, with no new safety signals. The effectiveness outcomes align with trends observed in key clinical trials. Clinical trial information: NCT05206890 .