Novel Balugrastim Well Tolerated in Pilot Study in Patients with Breast Cancer
Balugrastim was developed using an albumin-fusion platform technology by fusing r-metHuG-CSF to human serum albumin, reported David D. Shen, PhD, of Teva Biopharmaceuticals USA, Rockville, MD, USA, and colleagues.
They treated 13 patients with breast cancer with single, escalating, subcutaneous doses of balugrastim 50, 150, 300, and 450µg/kg 14 days prior to treatment with doxorubicin plus docetaxel. Serum levels of balugrastim were measured and relevant PK parameters, including AUC, Cmax, and half-life calculated. The PD parameter selected was mean change in absolute neutrophil count (ANC). The same PK and PD parameters were also determined in cycle 1 of chemotherapy.
The investigators observed a dose-dependent increase in bioavailability; ANC increased relative to historical data for pegfilgrastim, the comparator. At the balugrastim 450µg/kg dose level, PK parameters were comparable to 6mg fixed doses of subcutaneous pegfilgrastim, leading Dr. Shen to note that this “appears to be the optimal dose for further study.” Balugrastim was well tolerated in all patients treated.
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