Multinational phase 3 trial of efbemalenograstim alfa for reducing the risk of febrile neutropenia after chemotherapy for breast cancer

Efebemalenograstim alfa (F-627) is approved for reducing the risk of infection in chemotherapy-induced neutropenia. A multinational phase 3 trial evaluated safety and efficacy of efbemalenogastrim alfa in stage II-IV breast cancer patients receiving four three-week cycles of myelosuppressive chemotherapy (docetaxel plus doxorubicin; TA chemotherapy). Patients were randomized 2:1 to subcutaneous efbemalenogastrim alfa or placebo on day two of cycle one. The primary end point was duration of severe neutropenia (DSN) during the first cycle. The mean DSN was 1.3 days with efbemalenogastrim alfa versus 3.9 days with placebo (95% CI 2.3-3.4). The incidence of febrile neutropenia during cycle one was 4.8% versus 25.6% (p=0.0016). Intravenous antibiotics were required by 3.6% versus 17.9% (p=0.0119). Most adverse events werd consistent with those expected for breast cancer patients receiving TA chemotherapy. The authors conclude that efbemalenogastrim alfa is effective and safe for significantly decreasing the duration of severe neutropenia and the incidence of febrile neutropenia in breast cancer patients who are receiving TA chemotherapy.