Overview
Niraparib was approved for first-line maintenance (1LM) treatment of patients with advanced epithelial ovarian cancer (EOC) based on the results from the PRIMA trial, which did not include patients with stage III EOC who had no visible residual disease (NVRD) as a part of the study population. However, patients may be eligible for 1LM treatment with niraparib, thus there was an evidence gap on the treatment outcomes for these patients that this study aimed to understand.
The researchers found real-world time to next treatment and real-world progression-free survival in patients with stage III EOC who had NVRD were substantially improved compared to the real-world patients who met eligibility criteria similar to the PRIMA trial.
Why this matters
The findings of this study signal that the clinical benefit of niraparib may have been underestimated in the PRIMA trial relative to the overall eligible population due to the exclusion of patients with stage III EOC and NVRD. Using real-world data, this research highlights the need to interpret trial results within the context of the study design and population, and opens the door for future research into this niraparibt's effectiveness in a diverse group of EOC patients.