Generon's benegrastim meets in Phase III for CIN

Generon (Shanghai) Corp. Ltd. (Shanghai, China) reported data from a Phase III trial in about 122 women with stage II-IV breast cancer patients receiving myelotoxic chemotherapy with docetaxel and doxorubicin showing that a 20 mg dose of subcutaneous benegrastim (F-627) given 24 hours after chemotherapy met the primary endpoint of reducing the duration of severe chemotherapy-induced neutropenia (CIN) in the first chemotherapy cycle vs. placebo (p<0.0001).

Secondary endpoints in the double-blind, U.S. trial include duration and rate of mild, moderate and severe neutropenia, rate of febrile neutropenia, time to absolute neutrophil count (ANC) recovery post nadir, depth of the ANC nadir, rate of infections, use of antibiotic and pain medications and electrocardiogram endpoints...