Phase 2, Single-arm, Open-label Study to Evaluate the Safety and Efficacy of Niraparib Combined With Bevacizumab as Maintenance Treatment in Patients With Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Following Front-line Platinum-based Chemotherapy With Bevacizumab

Trial ID # NCT03326193; OVARIO
Phase II
Drug Class Angiogenesis Inhibitors: VEGF
Drug Name Bevacizumab
Alternate Drug Names immunoglobulin G1 (human-mouse monoclonal rhuMab-VEGF gamma-chain, anti-VEGF monoclonal antibody, Avastin
Drugs in Trial Carboplatin, Paclitaxel, Bevacizumab, Niraparib
Eligible Participant

Newly diagnosed high grade serous or endometrioid stage IIIb/IV ovarian cancer with CR or PR after first-line therapy

Patients Enrolled

105; 79% stage III, 63% w/ neoadjuvant chemotherapy

Therapy Setting

Maintenance

Study Design

Open-Label, Non-randomized

Endpoints

PFS, evaluated per RECIST

Efficacy

PFS: 19.6 months
PFS (BRCA MUT): NR
PFS (HRD): 28.3 months
PFS (HRP): 14.2 months

PFS (6 months): 90%
PFS (12 months): 75%
PFS (18 months): 62%
PFS (24 months): 53%

Conclusion

Bevacizumab+niraparib maintenance treatment does not appear to cause cumulative toxicities and shows promising PFS

Reference

Hardesty MM et al. OVARIO phase II trial of combination niraparib plus bevacizumab maintenance therapy in advanced ovarian cancer following first-line platinum-based chemotherapy with bevacizumab. Gynecol Oncol (2022) 166(2):219-229
https://pubmed.ncbi.nlm.nih.gov/35690498/

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