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Extended PARP maintenance to women without BRCA mutations, but the survival benefit did not materialise on longer follow-up.
PFS 13.8 vs 8.2 months overall (HR 0.62) and 21.9 vs 10.4 months in HRD-positive disease (HR 0.43; NEJM 2019), leading to an all-comers first-line maintenance approval in 2020. The final overall survival analysis (2024) showed no OS difference (HR 1.01 overall), and the HR-proficient subgroup's benefit was small, prompting label debates and a shift toward HRD-guided use.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
733 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival (HRD-positive)primary | Niraparib | - | 21.9 months | 0.43 (0.31 to 0.59) | - | link |
| Placebo | - | 10.4 months | ||||
| Progression-free survival (overall)primary | Niraparib | 487 | 13.8 months | 0.62 (0.5 to 0.76) | - | link |
| Placebo | 246 | 8.2 months |
Shares myChoice CDx, HRD genomic scar scores (GIS, LOH, HRDetect), High-grade serous ovarian cancer, Platinum-sensitive ovarian cancer.
Shares ctDNA-guided duration of PARP maintenance, High-grade serous ovarian cancer, Platinum-sensitive ovarian cancer, PARP.
Shares ctDNA-guided duration of PARP maintenance, High-grade serous ovarian cancer, Platinum-sensitive ovarian cancer, Homologous recombination deficiency (HRD).
Shares HRD genomic scar scores (GIS, LOH, HRDetect), High-grade serous ovarian cancer, Niraparib, Homologous recombination deficiency (HRD).
Shares Platinum-sensitive ovarian cancer, Homologous recombination deficiency (HRD), PARP, Ovarian cancer.
Shares Platinum-sensitive ovarian cancer, Niraparib, PARP inhibitors, Ovarian cancer.
Shares Platinum-sensitive ovarian cancer, PARP, PARP inhibitors, Ovarian cancer.
Shares High-grade serous ovarian cancer, Platinum-sensitive ovarian cancer, Niraparib, Homologous recombination deficiency (HRD).