Phase 2 trial of maintenance PARP inhibitor rechallenge plus bevacizumab for PARP-inhibitor-pretreated, platinum-sensitive, recurrent ovarian cancer

The multicenter phase 2 NIRVANA-R trial in South Korea evaluated PARP inibitor (PARPi) rechallenge combined with bevacizumab as maintenance therapy in patients with platinum-sensitive recurrent ovarian cancer previously treated with a PARPi. The trial enrolled 44 patients who had received two or more prior lines of platinum-based chemotherapy and prior PARPi maintenance. Eligible patients achieving a response to the most recent platinum therapy received daily niraparib and triweekly bevacizumab until disease progression or unacceptable toxicity. The primary endpoint was the 6-months progression-free survival (PFS) rate. The primary endpoint was met, with 26 of 44 patients (59.1%) remaining progression-free at 6 months. The median PFS was 11.5 months (95% CI 7.9-NR). Subgroup analyses suggested greater benefit in patients with a longer treatment-free interval after the penultimate chemotherapy and in those who achieved a complete response tot the most recent chemotherapy. Grade 3 or 4 treatment-related adverse events occurred in 27.3% of patients, with no treatment-related deaths of new safety signals. The authors conclude that the combination of niraparib and bevacizumab demonstrated promising activity in this setting.