On January 25, 2018 Generon Corporation, an innovative biotech company in China developing novel biological therapeutics, reported that the first pivotal phase III study in the U.S. for F-627 to treat chemotherapy-induced neutropenia (CIN) in breast cancer patients met the primary endpoint (Press release, Generon (Shanghai), JAN 25, 2018, View Source [SID1234523559]). F-627 (Benegrastim / BineutaTM) is a recombinant human granulocyte colony-stimulating factor (rhG-CSF) dimer with a best-in-class potential to manage CIN in in cancer patients. The primary endpoint was to shorten the duration in days of grade 4 (severe) neutropenia in the first chemotherapy cycle. Patients treated with F-627 demonstrated significantly reduced duration of severe neutropenia compared to patents in placebo group (P<0.0001).
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"We are delighted to announce the significant results seen in this study. This is an important step toward completing the F-627 regulatory package for BLA (biological licensee application) submission" said Dr. David Lacey, Generon’s Chairman of Scientific Advisor board. "We are in the process of further analysis of the data, and plan to submit the results for presentation at an upcoming major medical meeting. " said Dr. Xiaoqiang Yan, Generon’s Chairman and CEO, adding, "Meeting the primary end point of the first pivotal study is an important milestone for Generon, demonstrating our ability to be an innovative biotech company on a global level."
This Phase III trial is a randomized, multi-center, double-blind, placebo controlled Phase III study of the efficacy and safety of a once-per-cycle dose of F-627 in women with stage II-IV breast cancer who are receiving myelotoxic TA chemotherapy treatment (Taxotere (docetaxel) + Adriamycin (doxorubicin)). Subjects were randomized to F-627 or Placebo at 2:1 ratio. About 24 hours after chemotherapy, subjects received either 20 mg fixed dose F-627 or Placebo. The subjects’ absolute neutrophil count (ANC) was measured each day post chemotherapy administration until ANC levels exceeded 2.0 x 109/L, then the ANC value was determined every three days until the next chemotherapy cycle. This is one of two pivotal Phase III studies required for BLA submission in the US. The second Phase III study is under an SPA with the FDA and currently ongoing.
The management executives of Yifan Pharmaceuticals congratulated Generon’s team on this achievement and emphasized their continued confidence in Generon’s ability to pursue F-627’s clinical development toward a successful BLA submission, and to bring the best-in-class rhG-CSF to patients worldwide.
Chemotherapy-induced Neutropenia (CIN)
CIN occurs commonly during current cancer treatments involving cytotoxic chemotherapy. In the U.S. alone, it is estimated that approximately 1.7 million cancer patients receive chemotherapy treatment, which amounts to a total of 7.5 million chemotherapy cycles performed annually with approximately 5.0 million chemotherapy cycles involving CIN. The global CIN market is estimated to be at $7.0 billion with about >85% of patients still on first-generation of rhG-CSFs, and less than 15% of patients using second-generation rhG-CSFs, the pegylated rhG-CSF.
About F-627
F-627 (benegrastim) is under development for the treatment of CIN in cancer patients. F-627 is a recombinant fusion protein containing G-CSF and human IgG2-Fc and is expressed in Chinese Hamster Ovary (CHO) cells. F-627 has an immunoglobulin-like structure. It consists of two G-CSF molecules at the N-terminal of Fc fragments (a G-CSF dimer). G-CSF is a growth factor acting on the neutrophilic lineage in the hematopoietic system. G-CSF binds to specific G-CSF receptors (G-CSFR) on the cell surface and stimulates differentiation, proliferation, and activation of neutrophilic granulocytes. F-627 has showed stronger bioactivities than the monomeric rhG-CSFs in vitro and in vivo.