Treatment of Advanced Ovarian Cancer after Three or More Chemotherapies

QUADRA

Study Design

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 three or more prior lines of chemotherapy.1,2

Patient characteristics in the QUADRA trial (N=463) are representative of a real-world, late-line population2:

  • 27% of patients were 6th line or later
  • 68% of patients were platinum resistant or refractory

 

The FDA indication is for HRD+ patients (in QUADRA, n=98) with either1,3:

  • BRCA+ tumors regardless of platinum status
  • BRCA- tumors with genomic instability (GIS+) and had progressed more than 6 months after the last platinum-based chemotherapy

*19% of patients were 6th line or later.

BRCA+, breast cancer susceptibility gene mutated; BRCA-, not BRCA mutated; GIS, genomic instability score; HRD+, homologous recombination deficiency positive; ORR, overall response rate.

4th-Line+ Efficacy

Indicated for the treatment of 4th-line+ homologous recombination deficiency positive (HRD+) ovarian cancer defined by either1:

 

BRCA+ OR BRCA-, genomic instability positive (GIS+) platinum-sensititive disease1,4,5

 

Clinically meaningful, durable benefit was observed1,3

Median duration of response in the indicated population

 

AR, adverse reaction; BRCA+, breast cancer susceptibility gene mutated; BRCA-, not BRCA mutated; CI, confidence interval; GIS, genomic instability score; HRD+, homologous recombination deficiency positive; ORR, overall response rate.

Safety data

SAFETY DATA

Learn about the safety and tolerability of ZEJULA

See Safety
Dosing information

DOSE MODIFICATIONS

See recommendations for dose adjustments

Review Dosing

References: 1. ZEJULA (niraparib) [package insert]. Waltham, MA: GSK, Inc; October 2019. 2. Moore KN, Secord AA, Geller M, et al. Niraparib monotherapy for late-line treatment of ovarian cancer (QUADRA): a multicentre, open-label, single-arm, phase 2 trial. Lancet Oncol. 2019;20(5):636-648. 3. Moore KN, Secord AA, Geller M, et al. QUADRA: a phase 2, open-label, single-arm study to evaluate niraparib in patients (pts) with relapsed ovarian cancer in 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. 4. Rubraca (rucaparib) [package insert]. Boulder, CO: Clovis Oncology, Inc; April 2018. 5. Lynparza (olaparib) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; July 2019. 6. Berek JS, Matulonis U, Peen U, et al. Safety and dose modification for patients receiving niraparib. Ann Oncol. 2018;29(8):1784-1792. doi: 10.1093/annonc/mdy181. 7. Matulonis UA, Monk BJ, Secord AA, 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.