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In women having chemotherapy for breast cancer, a single dose of the new white-cell booster lipegfilgrastim kept the dangerous dip in white cells as short as the standard booster pegfilgrastim, with no cases of infection-related fever on the new drug.
Primary publication of XM22-03 (EudraCT 2009-015999-10), a phase 3, double-blind, randomised, active-controlled, non-inferiority trial. Patients with high-risk stage II, III or IV breast cancer and an absolute neutrophil count of at least 1.5 x 10^9 cells per litre were randomised to a single 6 mg subcutaneous injection of lipegfilgrastim (n = 101) or pegfilgrastim (n = 101) on day 2 of each 21-day doxorubicin and docetaxel cycle, for up to four cycles. The primary efficacy endpoint was the duration of severe neutropenia during cycle 1.
Mean duration of severe neutropenia in cycle 1 was 0.7 days with lipegfilgrastim and 0.8 days with pegfilgrastim (lambda -0.218, 95 percent CI -0.498 to 0.062; p = 0.126); no severe neutropenia was seen in 56 percent and 49 percent of patients. Across all cycles, febrile neutropenia occurred in three pegfilgrastim-treated patients (all in cycle 1) and none on lipegfilgrastim. Drug-related adverse events were reported in 28 percent and 26 percent.
This is the breast-cancer pivotal behind the 2013 EU authorisation of Lonquex, establishing lipegfilgrastim as an alternative once-per-cycle growth factor to pegfilgrastim. The confidence interval for lambda belongs to a Poisson-model effect estimate and is not a hazard ratio.
Shares Pegfilgrastim, Breast cancer (all types).
Shares Pegfilgrastim, Breast cancer (all types).
Shares Pegfilgrastim, Breast cancer (all types).
Shares Pegfilgrastim, Breast cancer (all types).
Shares Pegfilgrastim, Breast cancer (all types).
Shares Lipegfilgrastim, Pegfilgrastim.
Shares Teva Pharmaceuticals, Pegfilgrastim.