In the PRIMA trial, ZEJULA was assessed in patients with HRd tumors and then in the overall population1,2
The overall population included1*:
*The PRIMA trial included adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.
PFS in the OVERALL POPULATION (N=733)
†Censored subjects are indicated by circles.
In the HRd population, ZEJULA doubled median PFS compared with placebo1,2
PFS in the HRd POPULATION (n=373, 51% of overall population)
‡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.1,2
The PRIMA trial included patients with poor prognoses1,2,5-9
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 patient subgroups with poor prognoses, a reduction in the risk of disease progression or death was observed with ZEJULA compared with placebo1,2
These prespecified subgroup analyses were exploratory in nature and were not powered to detect a statistically significant treatment effect; therefore, results should be interpreted with caution.1,2
At the time of the PFS analysis, limited overall survival data were available with 11% deaths in the overall population.1
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 events2,10
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
Side effects of ZEJULA may be managed with dose interruption and modification1,2
- Adverse events led to dose interruptions or reduction in 80% of patients, most frequently from thrombocytopenia (56%), anemia (33%), and neutropenia (20%)
- No specific drug-drug interactions have been reported with ZEJULA||
||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 select hematologic adverse reactions were observed with an individualized starting dose1
- A reduction in the rate of thrombocytopenia (21% vs 39%), anemia (23% vs 31%), and neutropenia (15% vs 21%) was observed with individualized dosing vs the overall population, respectively
In PRIMA, patients in the overall and individualized populations experienced the same rates of Grades 3-4 leukopenia.
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.
PRIMA INCLUDED DIVERSE PATIENT SUBGROUPS1,4
ZEJULA IS APPROVED FOR ALL OF THEM
1L, first-line; AR, adverse reaction; 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.