Positive phase III results for F 627 in neutropenia in breast cancer.- Generon.

Generon BioMed announced positive results from a placebo-controlled trial with F 627 (benegrastim), a recombinant human Granulocyte Colony Stimulating Factor (rhG-CSF) protein, in a global study of 122 woman with stage II-IV breast cancer receiving Myelotoxic chemotherapy. Results demonstrate that subcutaneous administration of F-627 significantly reduced the duration of Grade 4 (severe) neutropenia in chemotherapy cycle 1 (P<0.0001); the mean treatment difference was 2.8 days (1.1 days vs. 3.9 days in the placebo arm). f-627 administration also resulted in lower incidence and shorter duration of grade 4, grade 3 and grade 2 neutropenia. other significant results included the finding that treatment with f-627 significantly reduced the incidence of febrile neutropenia (fn) (p><0.0016). the incidence of fn in the experimental arm was 4.8% and 28.2% in the placebo arm during cycle 1. subjects in the experimental arm also had lower rates of antibiotic medication and pain medication use.>

In this study, F-627 was shown to be safe and well tolerated with no deaths, no injection site reactions and less gastrointestinal AEs (diarrhea, vomiting, stomatitis, and gastritis) than the placebo arm. During cycle 1 in the experimental arm, the five most common TEAEs (incidence rate more than 10%) were leukopenia, anemia, thrombocytopenia, nausea, and alopecia. Across all cycles, there were 17 SAEs from 15 subjects of which 15 were FN. A single subcutaneous injection of F-627 significantly reduced the duration and incidence of severe neutropenia and febrile neutropenia while maintaining an excellent safety profile in patients with breast cancer undergoing high-dose chemotherapy. Data were presented at the annual San Antonio Breast Cancer Symposium.