Endpoints of Phase 2 Trial Assessing Niraparib in Treatment of Uterine Serous Carcinoma

Pharmacy Times interviewed Marina Frimer, MD, FACOG, FACS, gynecologic oncologist at the Northwell Health Cancer Institute and associate professor at Zucker School of Medicine in Hofstra/Northwell, on her presentation at the Society of Gynecologic Oncology 2022 annual meeting on the phase 2 trial of maintenance niraparib in patients with stage 3, stage 4, or platinum-sensitive recurrent uterine serous carcinoma.

During this interview, Frimer discussed the endpoints of the phase 2 trial assessing niraparib in patients with stage 3, stage 4, or platinum-sensitive recurrent uterine serous carcinoma.

Marina Frimer: The primary endpoint is to determine the progression-free survival at 1 year. There are multiple secondary endpoints. These include progression-free survival and overall survival response rate at 2 or 3 interval years from start of the treatments.

We want to describe the treatment-related adverse events and evaluate quality of life measures, and we hope to evaluate mutational burden, prevalence of somatic mutations, and loss of heterozygosity in these women with uterine serous carcinoma.