Study to Compare the Efficacy and Safety of F-627 and GRAN®

Summary

A Phase III, Multi-Center, Randomized, Open-Label, Active-Controlled Trial to Compare the Efficacy and Safety of Recombinant Human Granulocyte Colony Stimulating Factor-Fc Fusion Protein (F-627) and Recombinant Human Granulocyte Colony Stimulating Factor (GRAN®) in the Prophylactic Treatment for Chemotherapy-Induced Neutropenia

Timeline

Start

2018-04-12

Primary completion

2019-01-24

Completion

2019-06-19

Outcome

Met primary endpoint

paper upper limit of the one-sided 97.5% CI was 0 day, which was within the prespecified non-inferiority margin of 1-day. PMID 39272058 ↗

release “F-627 met its non-inferiority primary clinical endpoint versus Recombinant Human Granulocyte Colony Stimulating Factor (GRAN® / NEUPOGEN®)” evivebiotech.com ↗

Publications

• Zhang Q, Wang Z, Yao W, Wang S, Zhang G, Chen J, Hou Q, Li S, Li H, Ye C, Sun T, Yang H, Chen Z, Wang Z, Liu X, Geng C, Li X, Zhang J, Zheng H, Shao Z. A randomized, multicenter phase III Study of once-per-cycle administration of efbemalenograstim alfa (F-627), a novel long-acting rhG-CSF, for prophylaxis of chemotherapy-induced neutropenia in patients with breast cancer. BMC Cancer. 2024 Sep 13;24(1):1143. doi: 10.1186/s12885-024-12892-5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	F-627	Protein / enzyme biologic	20 mg	Subcutaneous
Comparator	GRAN®	Protein / enzyme biologic	5 ug/kg	Subcutaneous

Indications