Study Design: PRIMA, a randomized double-blind, placebo-controlled phase 3 trial, evaluated the safety and efficacy of ZEJULA in women (N=733) with newly diagnosed advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer following CR or PR to first-line platinum-based chemotherapy. Patients were randomized 2:1 to receive ZEJULA or placebo once daily. The primary endpoint was progression-free survival (PFS) in patients who had tumors that were HRd and in those in the overall population, as determined on hierarchical testing. PFS was measured from time of randomization to time of disease progression or death. At the time of the PFS analysis, limited overall survival data were available with 11% deaths in the overall population.1,2
ZEJULA (niraparib) Significantly Improved PFS in Newly Diagnosed Patients Who Responded to Platinum-Based Chemotherapy, Regardless of Biomarker Status1,2
Median PFS in PRIMA clinical trial1,2:
The overall population included1:
The safety and tolerability profile is well characterized and consistent with previous clinical trial experience1,2
12% of patients discontinued treatment with ZEJULA due to adverse events2,5
ARs resulting in discontinuation of ZEJULA in >1% of patients included thrombocytopenia (3.7%), anemia (1.9%), and nausea and neutropenia (1.2% each)
Adverse Reactions Reported in ≥10% of All Patients Receiving ZEJULA in PRIMA1
ASCO and NCCN Guidelines include ZEJULA as a recommended option6,7
NCCN CLINICAL PRACTICE GUIDELINES IN ONCOLOGY (NCCN GUIDELINES®)
Recommended Therapy Option for Certain Patients With Advanced Ovarian Cancer6
NCCN Guidelines® recommend niraparib (ZEJULA), an oral, once-daily PARP inhibitor, as an option for:
- Single-agent maintenance therapy in patients with advanced ovarian cancer who are in complete or partial response after surgery and 1L platinum-based chemotherapy
- Single-agent maintenance therapy for patients with platinum-sensitive recurrent epithelial ovarian cancer who are in a complete or partial response after ≥2 lines of platinum-based chemotherapy, including the most recent line
- Single-agent recurrence therapy for patients with ovarian cancer who have been treated with ≥3 prior chemotherapy regimens and whose cancer is associated with HRD defined by either 1) a deleterious or suspected deleterious BRCA mutation or 2) genomic instability and progression >6 months after response to the last platinum-based chemotherapy
NCCN makes no warranties of any kind whatsoever regarding their content, use, or application, and disclaims any responsibility for their application or use in any way. To view the most recent and complete version of the guidelines, go online to NCCN.org.
ASCO GUIDELINE ON PARP INHIBITORS IN THE MANAGEMENT OF OVARIAN CANCER
ZEJULA Is a Recommended Therapy Option for Certain Patients With Advanced Ovarian Cancer7
The ASCO Guideline recommends ZEJULA, an oral, once-daily PARP inhibitor, as an option across multiple settings7:
- 1L maintenance: women with newly diagnosed stage III-IV EOC that is in CR/PR to 1L platinum-based chemotherapy should be offered PARPi maintenance therapy with niraparib (all women) for treatment of high-grade serous or endometrioid ovarian cancer*†
- 2L+ maintenance: niraparib maintenance is an option for patients with EOC who are PARPi-naïve and who have responded to platinum-based therapy regardless of BRCA mutation status†
*Recommendation applies to patients who are PARPi-naïve.
†Excerpt of ASCO recommendation is shown; please consult the ASCO Guidelines for complete recommendations on the use of PARP inhibitors for the management of EOC, including other PARP inhibitors and other treatment lines. Please note that the ASCO Guidelines include information about niraparib that has not been approved by the FDA and/or is inconsistent with its prescribing information.
1L, first-line; 2L+, second-line or more; ALT, alanine transaminase; AR, adverse reaction; ASCO, American Society of Clinical Oncology; AST, aspartate transaminase; BRCA, breast cancer susceptibility gene; BRCA+, BRCA-mutated; BRCA–, not BRCA-mutated; CI, confidence interval; CR, complete response; EOC, epithelial ovarian, tubal, or primary peritoneal cancer; HR, hazard ratio; HRD, homologous recombination deficiency; HRd, homologous recombination deficient; HRp, homologous recombination proficient; NCCN, National Comprehensive Cancer Network; PARP, poly (ADP-ribose) polymerase; PARPi, poly (ADP-ribose) polymerase inhibitor; PFS, progression-free survival; PR, partial response.