Maintenance Senaparib Improved PFS Among Patients With Newly Diagnosed, Advanced Ovarian Cancer
According to results from the phase 3 FLAMES study, maintenance senaparib in the first-line setting significantly reduced the risk of progression or death among patients with newly diagnosed, stage 3 to 4 high-grade serous or endometrioid ovarian cancer who had previously achieved complete or partial response with first-line platinum-based chemotherapy, irrespective of BRCA status.
These results were presented at the European Society for Medical Oncology Congress in Madrid, Spain, by lead author Xiaohua Wu, MD, PhD, Fudan University Cancer Institute, Shanghai, China.
“PARP inhibitors are recommended as maintenance therapy to prolong the benefit of platinum,” stated Dr Wu and coauthors. “Senaparib is a novel, highly potent PARP inhibitor.”
In this double-blinded, placebo-controlled study, 404 patients with newly diagnosed, stage 3 to 4 high-grade serous or endometrioid ovarian cancer were randomized on a 2-to-1 basis to receive either 100 mg senaparib once daily (n = 270) or placebo (n = 133). Treatment arms were stratified by response (complete or partial) and BRCA status. The primary end point was progression-free survival (PFS) evaluated by blinded independent central review (BICR).
At a median follow-up of 22.4 months in the senaparib arm and 22.2 months in the placebo arm, primary analysis indicated senaparib significantly improved PFS compared to placebo. The median PFS in the senaparib arm was not reached and in the placebo arm was 13.6 months (hazard ratio [HR], 0.43; 95% confidence interval [CI] 0.32 to 0.58; P < .0001) irrespective of BRCA status (HR, 0.43; P < .01). Grade ≥3 adverse events occurred in 66.3% of patients in the senaparib arm and 20.3% of patients in the placebo arm. Adverse events that led to dose reductions occurred in 63.3% and 6.0% of patients, respectively. Discontinuation occurred in 4.4% of patients in the senaparib arm. No adverse events resulted in death.
“[First-line] maintenance senaparib led to an unprecedented reduction in the risk of progression or death versus placebo in [ovarian cancer], regardless of biomarker status,” concluded Dr Wu and coauthors.
Source:
Wu X, Liu J, Wang X, et al. Efficacy and safety of senaparib as maintenance treatment in patients with newly diagnosed advanced ovarian cancer (FLAMES study): A randomized, double-blind, placebo-controlled, phase III trial. Presented at the 2023 ESMO Congress; October 20- 24, 2023; Madrid, Spain. Abstract LBA36
