Introduction FLAMES is a randomized, double-blind, placebo-controlled, phase 3 trial to evaluate efficacy and safety of senaparib as first line (1L) maintenance therapy in patients with newly diagnosed advanced ovarian cancer (OC).
Methods Chinese patients with newly diagnosed, FIGO stage III-IV, high-grade serous or endometrioid OC who had achieved complete response (CR) or partial response (PR) to 1L platinum-based chemotherapy were randomized (2:1) to receive senaparib or placebo. Primary endpoint was progression-free survival (PFS ) evaluated by BICR according to RECIST v1.1. A prespecified subgroup analysis was performed based on FIGO stage (III vs IV), BRCA mutation (positive vs negative), 1L treatment response (CR vs PR), neoadjuvant chemotherapy (yes vs no) and presence of residual disease after debulking surgery (yes vs no).
Results 404 patients were randomized to receive senaparib vs placebo with a median follow up of 22.4 and 22.2 months, respectively. PFS was significantly increased in senaparib arm (HR 0.43, 95% CI 0.32–0.58, P < 0.0001) over placebo. All subgroup analysis demonstrated consistent treatment benefit ( HR <0.50, P<0.0001, figure 1). Incidence rates of grade ≥3 adverse events (AEs) were 66.3% vs 20.3%, respectively. The most common grade ≥3 AEs were anemia (29.3%) , thrombocytopenia (26.7%), and neutropenia (24.8%) after received senaparib. No new safety signals were identified among all subgroups.
Conclusion/Implications Maintenance senaparib significantly improved PFS regardless of FIGO stage, 1L treatment response, surgical timing and residual disease status versus placebo in patients with newly diagnosed advanced OC.
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