Niraparib Therapy Shows Efficacy in Patients With Newly Diagnosed Advanced Ovarian Cancer

The objective of the study was to find whether niraparib improves PFS in patients with newly diagnosed advanced ovarian cancer after first-line (1L) platinum-based chemotherapy (CT).

A study presented in conjunction with the Society of Gynecologic Oncology 2020 Annual Meeting on Women’s Cancer showed that niraparib improved progression-free survival (PFS) as evidenced by a reduction in the risk of recurrence or death due to any cause in the overall population of advanced ovarian cancer.

The objective of the study was to find whether niraparib improves PFS in patients with newly diagnosed advanced ovarian cancer after first-line (1L) platinum-based chemotherapy (CT).

The phase 3, double-blind, placebo-controlled study randomized 733 patients with newly diagnosed advanced ovarian, primary peritoneal, or fallopian tube cancer with a complete or partial response to 1L platinum-based CT.

Patients received niraparib or placebo once daily. The primary endpoint of PFS assessed by blinded independent central review was analyzed using a stratified Cox proportional hazards model. A biomarker subgroup analysis of PFS was a prespecified exploratory analysis and was performed using a stratified log-rank test and summarized using Kaplan-Meier methodology.

Fifty-one percent of 733 randomized patients were homologous recombination deficient and 34% were homologous recombination proficient. Overall, 35% had stage IV disease, 67% received neoadjuvant CT, and 31% had a partial response to 1L CT.

Patients treated with niraparib in all the biomarkers groups had a statistically significant and clinically meaningful benefit in PFS. The most common adverse events included anemia, thrombocytopenia, and neutropenia.

REFERENCE

Monk B, Martin A. Efficacy of niraparib therapy in patients with newly diagnosed advanced ovarian by BRCA and homologous recombination status. SGO 2020. https://sgo.confex.com/sgo/2020/meetingapp.cgi/Paper/15986. Presented March 29, 2020. Accessed April 2, 2020.