NOW APPROVED AS FIRST-LINE MAINTENANCE MONOTHERAPY
FOR advanced ovarian cancer following a response to platinum chemotherapy1
NOW APPROVED FOR 1L MAINTENANCE1
The first and only once-daily oral PARP inhibitor for platinum-responsive advanced ovarian cancer1-3
PROVEN EFFICACY IN 1L MAINTENANCE REGARDLESS OF BIOMARKER STATUS1,4
PFS in the OVERALL POPULATION (N=733)
*Censored subjects are indicated by circles.
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 PFS in patients who had tumors that were HRd and then in the overall population, as determined on hierarchical testing. PFS was measured from time of randomization to time of disease progression or death.1,4
The PRIMA trial included patients with poor prognoses1,4,5
85% of patients had residual disease following primary debulking surgery‡
‡Stage III and IV disease with visible residual tumor (>0 cm) after primary debulking surgery.5
In the HRd population, ZEJULA doubled median PFS compared with placebo1,4
PFS in the HRd population (n=373, 51% of overall study population)
*Censored subjects are indicated by circles.
The safety and tolerability profile is well characterized and consistent with previous clinical trial experience1,4
12% of patients discontinued treatment with ZEJULA due to adverse events4,6
AEs 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 in PRIMA
Side effects of ZEJULA may be managed with dose interruption and modification1,4
- Adverse events led to dose interruptions and reduction in 80% of patients, most frequently from thrombocytopenia (56%), anemia (33%), and neutropenia (20%)
- No specific drug-drug interactions have been reported with ZEJULA1,||
||No clinical drug interaction studies have been performed with ZEJULA.
Starting dose for 1L maintenance is based on baseline weight and platelet count1
PRIMA prospectively evaluated the safety and efficacy of an individualized starting dose of either 200 mg or 300 mg, selected based on baseline weight and platelet count, as well as a fixed starting dose of 300 mg1
Lower rates of hematologic adverse reactions were observed with an individualized starting dose1
- A reduction in the rate of thrombocytopenia was observed with individualized dosing (21%) vs the overall population (39%)
- A reduction in the rate of anemia was observed with individualized dosing (23%) vs the overall population (31%)
- A reduction in the rate of neutropenia was observed with individualized dosing (15%) vs the overall population (21%)
Monitoring complete blood counts, blood pressure, and heart rate helps identify the need to dose modify.1
1X a week: 1st month | 1X a month: Rest of year | 1X every 2-3 months: After year 1¶
BLOOD PRESSURE AND HEART RATE
1X a week: 1st and 2nd month | 1X a month: Rest of year | 1X every 2-3 months: After year 1¶
¶Monitor periodically. Schedule provided as an example.
1L, first-line; BRCA+, breast cancer susceptibility gene mutated; BRCA−, not BRCA-mutated; CI, confidence interval; CR, complete response; HR, hazard ratio; HRd, homologous recombination deficient; HRp, homologous recombination proficient; PARP, poly (ADP-ribose) polymerase; PFS, progression-free survival; PR, partial response.
References: 1. ZEJULA (niraparib) [package insert]. Research Triangle Park, NC: GlaxoSmithKline; April 2020. 2. Lynparza (olaparib) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; December 2019. 3. Rubraca (rucaparib) [package insert]. Boulder, CO: Clovis Oncology, Inc; April 2018. 4. González‑Martín A, Pothuri B, Vergote I, et al; for the PRIMA/ENGOT-OV26/GOG-3012 Investigators. Niraparib in patients with newly diagnosed advanced ovarian cancer. N Engl J Med. 2019;381(25):2391-2402. 5. Data on file. 2020N435433_00. GlaxoSmithKline. 6. González‑Martín A, Pothuri B, Vergote I, et al; for the PRIMA/ENGOT-OV26/GOG-3012 Investigators. Niraparib in patients with newly diagnosed advanced ovarian cancer [supplementary appendix]. N Engl J Med. 2019;381(25):2391-2402.
THE ONLY ONCE-DAILY ORAL PARP INHIBITOR WITH PROVEN EFFICACY REGARDLESS OF BRCA STATUS1-4
ZEJULA is the first and only once-daily PARP inhibitor for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.1-3
The primary endpoint of the pivotal trial (NOVA), was progression-free survival (PFS) 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 17% of survival events occurring in the study.1,4,5
Median PFS in the NOVA clinical trial:
BRCA, breast cancer susceptibility gene; CI, confidence interval; gBRCAmut, germline BRCA mutated; HR, hazard ratio; non-gBRCAmut, not germline BRCA mutated; PARP, poly(ADP-ribose) polymerase; PFS, progression-free survival.