A Randomized Multicenter Phase III Study of Single Administration of Mecapegfilgrastim (HHPG-19K), A Pegfilgrastim Biosimilar, for Prophylaxis of Chemotherapy-Induced Neutropenia in Patients With Advanced Non-Small-Cell Lung Cancer (NSCLC).

Mecapegfilgrastim (code name HHPG-19K) is a biosimilar to pegylated recombinant human granulocyte-colony stimulating factor (PEG-rhG-CSF). The efficacy and safety of mecapegfilgrastim using a regimen of once-per-cycle injection of 100-μg/kg or fixed 6-mg dose was evaluated for the prophylactic therapy of neutropenia in advanced non-small-cell lung cancer (NSCLC) patients treated with myelosuppressive chemotherapy.Patients were randomized (1:1:1) blindly to 3 treatment arms to receive a single injection of mecapegfilgrastim 100 μg/kg, mecapegfilgrastim 6-mg fixed dose, or saline (control) in cycle 1. In cycles 2 to 4 following unblinding at the end of cycle 1, patients in the control arm received daily injection of short-acting rhG-CSF at a dose of 5 μg/kg, whereas patients in the 2 mecapegfilgrastim arms continued the same treatment as in cycle 1. All patients received 4 chemotherapy cycles of docetaxel combed with cisplatin or carboplatin every 21 days. The primary endpoint was the incidence of grade ≥ 3 neutropenia in cycle 1.A single dose of 100 μg/kg or a fixed 6-mg dose mecapegfilgrastim per cycle effectively reduced chemotherapy-induced neutropenia and was comparable to daily rhG-CSF with regard to all efficacy endpoints, including incidence of grade ≥ 3 neutropenia, incidence of febrile neutropenia, the duration of grade ≥ 3 neutropenia, and time to neutrophil recovery. No difference in efficacy parameters was observed between the 2 dose regimens of mecapegfilgrastim across all cycles. Mecapegfilgrastim was well-tolerated and as safe as daily rhG-CSF.Once-per-cycle injection of mecapegfilgrastim is as effective and safe as daily rhG-CSF for prophylaxis of chemotherapy-induced neutropenia in NSCLC patients. Mecapegfilgrastim (fixed 6-mg dose) is recommended in clinical practice for its convenient dose management.