An open-label, multi-center, single-arm, phase 2 study of fluzoparib in patients with germline BRCA1/2 mutation and platinum-sensitive recurrent ovarian cancer
Mené sur 113 patientes présentant une mutation constitutionnelle BRCA et atteintes d'un cancer de l'ovaire sensible aux sels de platine et récidivant, cet essai de phase II évalue l'efficacité, du point de vue du taux de réponse objective, du fluzoparib (durée médiane de suivi : 15,9 mois)
Purpose: Fluzoparib (PARP inhibitor) showed promising anti-tumor activity for advanced ovarian cancer in a phase 1 study. This study aimed to assess the efficacy and safety of fluzoparib in patients with germline BRCA1/2-mutated recurrent ovarian cancer. Methods: This open-label, multi-center, single-arm, phase 2 study enrolled patients with platinum-sensitive recurrent ovarian cancer and germline BRCA1/2 mutation who had previously received 2−4 lines of platinum-based chemotherapy. Fluzoparib 150 mg was administered orally twice daily. The primary endpoint was independent review committee (IRC)-assessed objective response rate per RECIST v1.1. Results: 113 patients were enrolled and received at least one dose of fluzoparib. As of data cutoff on March 21, 2020, the median follow-up period was 15.9 months (IQR 13.5-18.5). The IRC- and investigator-assessed objective response rates were 69.9% (95% CI 60.6-78.2) and 70.8% (95% CI 61.5-79.0), respectively. The objective response rates were similar across all pre-specified subgroups. The median IRC- and investigator-assessed progression-free survival was 12.0 months (95% CI 9.3-13.9) and 10.3 months (95% CI 9.2-12.0), respectively. The 12-month survival rate was 93.7% (95% CI 87.2-96.9). Grade {greater than or equal to}3 adverse events occurred in 63.7% (72/113) of the patients, with the most common one being anaemia/decreased haemoglobin. Adverse events that led to treatment interruption, dose reduction, and discontinuation occurred in 39.8%, 34.5%, and 0.9% of patients, respectively. One treatment-related death occurred. Conclusions: Fluzoparib demonstrated promising anti-tumor activity and acceptable safety profile in germline BRCA1/2-mutated, platinum-sensitive relapsed ovarian cancer. Thus, fluzoparib might be a novel treatment option for this population. Clinical Trial number: NCT03509636