A Study of ZL-2306 (Niraparib) as Maintenance Treatment Following First-line Chemotherapy in Patients With Advanced Ovarian Cancer

Summary

Niraparib is a PARP inhibitor. This is a 2:1 randomized, double-blind, placebo-controlled study conducted in patients with advanced (FIGO Stage III or IV) ovarian cancer to evaluate Efficacy and Safety of ZL-2306 (Niraparib) for Maintenance Treatment

Timeline

Start

2018-06-30

Primary completion

2022-01-29

Completion

2023-12-30

Outcome

Met primary endpoint

paper Median PFS with niraparib vs placebo was 24.8 vs 8.3 months (hazard ratio [HR], 0.45; 95% CI, 0.34-0.60; P < .001) in the intention-to-treat population; PMID 37440217 ↗

release “the Phase 3 PRIME study of ZEJULA as maintenance therapy met its primary endpoint” zailaboratory.com ↗

release “The primary endpoint of the trial was met, with median progression-free survival of 24.8 months for niraparib patients versus 8.3 months for patients taking placebo” zailaboratory.com ↗

release “The Phase 3 PRIME study demonstrates that treatment with ZEJULA significantly extends progression-free survival versus placebo” zailaboratory.com ↗

Publications

• Li N, Zhu J, Yin R, Wang J, Pan L, Kong B, Zheng H, Liu J, Wu X, Wang L, Huang Y, Wang K, Zou D, Zhao H, Wang C, Lu W, Lin A, Lou G, Li G, Qu P, Yang H, Zhang Y, Cai H, Pan Y, Hao M, Liu Z, Cui H, Yang Y, Yao S, Zhen X, Hang W, Hou J, Wang J, Wu L. Treatment With Niraparib Maintenance Therapy in Patients With Newly Diagnosed Advanced Ovarian Cancer: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2023 Sep 1;9(9):1230-1237. doi: 10.1001/jamaoncol.2023.2283.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Niraparib	Small molecule	200 mg	—
Subject	Niraparib	Small molecule	300 mg	—

Indications