Balugrastim: Phase II/III data

Data from the Phase III portion of a Phase II/III trial in 256 breast cancer patients receiving myelosuppressive therapy showed that subcutaneous injections of 40 and 50 mg balugrastim were both non-inferior to subcutaneous injections of 6 mg Neulasta pegfilgrastim on the primary endpoint of reducing the mean duration of severe chemotherapy-induced neutropenia in cycle 1 of treatment (1 and 1.3 days, respectively, vs. 1.2 days). The type and frequency of treatment-related adverse events was similar across treatment groups.

In the dose-escalation Phase II portion of the trial, 78 patients were randomized to receive 30, 40 or 50 mg balugrastim or Neulasta given 1 day after chemotherapy. Teva said the duration of severe neutropenia and safety were similar across all treatment arms and the 40 and 50 mg doses of balugrastim were selected for further investigation. Data were presented at the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology meeting on Supportive Care in Cancer in New York. ...