Predictors of Long-term Progression-Free Survival in Niraparib-Treated Patients in the PRIMA/ENGOT-OV16/GOG-3012 Study

Whitney S. Graybill, MD, MS, presents data from an analysis of the phase 3 PRIMA trial that looked to identify baseline characteristics associated with long-term progression-free survival with niraparib in patients with advanced ovarian cancer.

Background

  • Niraparib was approved as maintenance therapy for pts with advanced ovarian cancer (OC) after complete or partial response (CR/PR) to first-line (1L) platinum-based chemotherapy (CT) based on results from the PRIMA study.
  • In this post hoc analysis, we identified factors associated with long-term PFS.

Methods

  • PRIMA is a phase 3, randomized study of patients with newly diagnosed advanced high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancer at high risk for relapse with CR/PR after 1L platinum-based CT.
  • Patients were randomized 2:1 to niraparib 200 or 300 mg or placebo QD, and stratified by best response to 1L CT (CR/PR), neoadjuvant CT (yes/no), and homologous recombination deficiency (HRD) status (deficient [HRd]/proficient or not determined [HRp/nd]).
  • Investigator-assessed PFS was dichotomized in niraparib-treated patients with progressive disease (PD)/censoring <2 years vs PD/censoring ≥2 years after randomization (data cut, Nov 17, 2021).
  • Logistic regression modeling using backward elimination (significance level=0.15) was used to identify baseline covariates associated with long-term PFS.

Results

  • Of 487 niraparib-treated patients, 152 (31%) had PD/censoring ≥2 years after randomization.
  • Odds ratios (OR) for PFS ≥2 years by baseline subgroup are shown.
  • The logistic regression model showed that BRCA mutation and HRD status, International Federation of Gynecology and Obstetrics (FIGO) stage, fallopian tube as the site of the primary tumor, and absence of baseline nontarget lesions were associated with longer PFS.
  • Eastern Cooperative Oncology Group (ECOG) performance score, body mass index, age, time from CT to randomization, number of target lesions, best response after CT, number of CT cycles, type of debulking surgery, and residual disease were not associated with PFS ≥2 years.
  • Safety has been reported previously (Ann Oncol. 2022;33[suppl 7]:S789).

Conclusions

  • Results suggest that long-term PFS in patients treated with niraparib may be associated with BRCA/HRd biomarker status, FIGO stage, primary tumor site, and number of baseline non-target lesions.
  • These data are hypothesis generating.

Graybill W, Pardo B, O'Malley DM et al. Predictors of long-term progression-free survival (PFS) in niraparib-treated patients (pts) from the PRIMA/ENGOT-OV26/GOG-3012 study. Abstract presented at: 2023 ASCO Annual Meeting, June 2-6, 2023.