NOVA Trial Dosing
For Recurrent Ovarian Cancer1
The approved starting dose of ZEJULA for recurrent ovarian cancer is 300 mg/day
ZEJULA Recommended Dose Modifications for Adverse Reactions1
Side Effects of ZEJULA May Be Managed With Dose Interruption and Modification1,2
In the NOVA trial, adverse reactions led to dose reduction or interruption in 69% of patients, most frequently from thrombocytopenia (41%) and anemia (20%). Discontinuation due to hematologic adverse reactions was uncommon for thrombocytopenia (3%), neutropenia (2%), and anemia (1%).
Incidence of ARs, grade 3/4, by dose at onset, ≥5%2
aThrombocytopenia includes reports of thrombocytopenia and decreased platelet count.
bAnemia includes reports of anemia and decreased hemoglobin counts.
cNeutropenia includes reports of neutropenia, decreased neutrophil count, and febrile neutropenia.
- The incidence of grade 3/4 thrombocytopenia by dose at onset was 2.3%, 5.9%, and 33.2% for patients receiving ZEJULA doses of 100 mg, 200 mg, and 300 mg, respectively2
An Exploratory Subgroup Analysis in NOVA Suggested Efficacy Was Not Compromised by Dose Reduction3
The analysis is exploratory in nature; it does not control for type 1 error and is not powered to determine treatment effect in any subgroup.
- Interrupt and reduce dose at the first sign of unacceptable toxicity1
∗In a post hoc analysis, the estimated PFS probability by dose level was measured after cycle 3 for patients regardless of BRCA status (ie, time 0 = month 3 of treatment). Patients who began ZEJULA at 300 mg and were titrated to their individual maximum tolerated dose achieved a similar PFS benefit regardless of the final dose level.4
†Censored subjects are indicated by circles.
The Side Effect Profile of ZEJULA Is Well Characterized1
- No on-treatment deaths were reported during the trial5
ALT, alanine aminotransferase; AST, aspartate aminotransferase; BRCA, breast cancer susceptibility gene; BRCA−, not BRCA-mutated; PFS, progression-free survival.