FDA-approved indications for ZEJULA1
*In QUADRA, HRD-positive status (HRD+) was determined using the Myriad my Choice CDx as either BRCA+ and/or GIS+ (genomic instability score [GIS] ≥42).
Median duration of response in the indicated population
Safety signals observed in QUADRA were consistent with those found in NOVA1
However, rates of most common ARs observed were different from NOVA and fatal adverse reactions occurred in 2% of patients, including cardiac arrest. Serious adverse reactions occurred in 43% of patients receiving ZEJULA. Serious adverse reactions in >3% of patients were small intestinal obstruction (7%), vomiting (6%), nausea (5%), and abdominal pain (4%).
ARs in QUADRA led to:
Dose reduction or interruption, 73%
Most frequently from:
- Thrombocytopenia, 40%
- Anemia, 11%
- Neutropenia, 11%
- Nausea, 13%
- Vomiting, 11%
- Fatigue, 9%
- Abdominal pain, 5%
The approved starting dose for ZEJULA is 300 mg (3x100 mg capsules)1
Retrospective, post hoc analyses from QUADRA and NOVA consistently demonstrate that baseline body weight <170 lb (77 kg) or baseline platelet count <150,000/μL are predictors of early dose modification.5,6
QUADRA evaluated ZEJULA as treatment in 4th-line+ patients, including those with BRCA− or platinum-resistant disease1
QUADRA: a single-arm, phase 2 trial of patients (N=463) with advanced ovarian cancer who have been treated with 3 or more prior lines of chemotherapy1,7
Patient characteristics in the QUADRA trial (N=463) are representative of a real-world, late-line population7
- 27% of patients were 6th line or later
- 68% of patients were platinum resistant or refractory
Most BRCA+ patients were platinum resistant or refractory (59%)
*19% of patients were 6th line or later.
BRCA+, breast cancer susceptibility gene mutated; BRCA−, not BRCA mutated; CI, confidence interval; CR, complete response; DOR, duration of response; GIS, genomic instability status; HRD+, homologous recombination deficiency positive; NE, not evaluable; ORR, overall response rate; PARP, poly (ADP-ribose) polymerase; PR, partial response.
References: 1. ZEJULA [package insert]. Waltham, MA: TESARO, Inc.; October 2019. 2. Rubraca (rucaparib) [package insert]. Boulder, CO: Clovis Oncology, Inc; April 2018. 3. Lynparza (olaparib) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; July 2019. 4. Moore KN et al. QUADRA: a phase 2, open-label, single-arm study to evaluate niraparib in patients with relapsed ovarian cancer in the 4th or later line of therapy: results from the BRCAmut subset. Poster presented at: European Society for Medical Oncology Annual Meeting; October 19-23, 2018; Munich, Germany. 5. Berek JS et al. Safety and dose modification for patients receiving niraparib. Ann Oncol. 2018;29(8):1784-1792. 6. Matulonis U et al. Baseline platelet count and body weight as predictors of early dose modification in the QUADRA trial of niraparib monotherapy for the treatment of heavily pretreated (≥4th line), advanced, recurrent high-grade serous ovarian cancer. Slide deck presented at: 50th Annual Meeting of the Society of Gynecologic Oncology; March 16-19, 2019; Honolulu, HI. 7. Moore KN et al. Lancet Oncol. 2019;20(5):636-648.