No OS benefit of niraparib maintenance in high-risk ovarian cancer

Previous results of the phase 3 PRIMA/ENGOT-OV26/GOG-3012 study (NCT02655016) showed a significant progression-free survival (PFS) benefit of niraparib maintenance therapy versus placebo in patients with newly diagnosed advanced ovarian cancer at high risk for disease recurrence [1]. After a median follow-up of 6.2 years, Dr Antonio González-Martin (Clínica Universidad de Navarra, Spain) presented the final overall survival (OS) results of the PRIMA study [2].

Among participants alive at 5 years in the homologous recombination-deficient (HRD) population, participants who received niraparib were twice as likely to be progression-free than those who received placebo: 35% versus 16%, respectively (HR 0.51; 95% CI 0.40–0.66). However, no difference was observed in OS rate at 5 years between the niraparib and placebo arms (62.5% maturity): 55% versus 56%. This could be due to a 3-fold higher subsequent PARP inhibitor use in the placebo arm than in the niraparib arm across populations. Long-term PFS remained statistically significant. Long-term safety remained consistent with the established safety profile of niraparib.

1. González-Martin A, et al. N Engl J Med 2019;381:2391-2402.
2. Gonzáléz-Martin A, et al. Final overall survival in patients with newly diagnosed advanced ovarian cancer treated with niraparib first-line maintenance: results from PRIMA/ENGOT-OV26/GOG-3012. Abstract LBA29, ESMO Congress 2024, 13–17 September, Barcelona, Spain.

 

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Posted on 4 November 20245 November 2024