Evive Biotech announced that its pivotal Phase III study evaluating F-627 (efbemalenograstim alpha) to treat chemotherapy-induced neutropenia (CIN) in breast cancer patients has met its primary and secondary endpoints. This trial concludes the global development program for F-627, which also includes successfully completed placebo-controlled and Neupogen-controlled Phase 3 trials. In total, the program involved 10 trials and over 1,200 subjects. Data from the phase 3 program will be submitted as part of the Biologic License Application (BLA) filing to the U.S. FDA, and the Market Authorization Application (MAA) filing to the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
This global pivotal Phase III trial was conducted under a Special Protocol Assessment (SPA) in agreement with the U.S. FDA. The multi-center, randomized, single dose, double-blind, active-controlled study compared the efficacy and safety of F-627 (dimeric recombinant human granulocyte colony stimulating factor-fc fusion protein) and Neulasta (pegylated recombinant methionyl human granulocyte colony stimulating factor) in the prophylactic treatment of chemotherapy-induced neutropenia in women with breast cancer receiving myelotoxic TC chemotherapy treatment (docetaxel + cyclophosphamide). The primary endpoint was the duration of grade 4 (severe) neutropenia (ANC < 0.5 x 109/L) defined as the number of days in which the subject has had an ANC < 0.5 × 109/L during cycle 1 of their chemotherapy treatment.
About F-627 (efbemalenograstim alpha)
F-627 (efbemalenograstim alpha) increases the production of white blood cells (neutrophils) which are a key part of the immune system’s ability to fight infection. A low concentration of these cells is a common side-effect of chemotherapy, and boosting their levels strengthens the immune system, meaning that patients are less likely to succumb to infections during treatment with chemotherapy.
About Chemotherapy-Induced Neutropenia (CIN)
CIN occurs commonly during current cancer treatments involving cytotoxic chemotherapy. CIN affects more than eight million people every year with around one million people affected in the United States alone.