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A retrospective study found that first-line niraparib maintenance dramatically outperformed in HRD-positive vs. HRD-negative advanced ovarian cancer patients who had no residual disease after surgery. Median progression-free survival was 54 months vs. 14 months, and overall survival was not yet reached vs. 37 months, respectively. The findings help fill a gap left by the pivotal PRIMA trial, which excluded this patient group.
A retrospective study presented at the 2026 ESMO Congress sheds new light on how niraparib (Zejula) performs as first-line maintenance therapy in a patient group largely left out of landmark trials. Among advanced ovarian cancer patients who achieved complete tumor removal (no residual disease) after primary cytoreductive surgery, those with HRD-positive tumors fared significantly better than their HRD-negative counterparts.
The study analyzed 40 molecularly evaluable patients treated with niraparib through an expanded access program in Rome between 2020 and 2021. HRD-positive and HRD-negative tumors each made up half the cohort, and 97% had high-grade serous histology. Notably, the phase 3 PRIMA trial — which established niraparib's first-line role — had excluded stage III patients with no residual disease, making this real-world data especially valuable.
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Why it matters: These findings reinforce the importance of HRD testing in guiding PARP inhibitor use — even in patients considered "optimally treated" by surgical standards. With the FDA having narrowed niraparib's first-line indication to HRD-positive patients in June 2025, this data supports that regulatory shift and could help oncologists better personalize maintenance therapy decisions.
