2075P - MW05, a novel, long-acting recombinant human serum albumin/human granulocyte-colony stimulating factor(I) fusion protein for the management of chemotherapy-induced neutropenia: Results of a phase III trial

Background

MW05 is a novel, long-acting recombinant human granulocyte-colony stimulating factor, which is produced by fusion of N terminal of highly active modified G-CSF with C terminal of human serum albumin(HSA). We report results from a randomized, double-blind, phase III study comparing the efficacy and safety of MW05 to approved PEG-rhG-CSF(Jinyouli®) for preventing chemotherapy-induced neutropenia.

Methods

Patients with breast cancer were randomized 2:1 to receive MW05 or PEG-rhG-CSF after standard docetaxel plus cyclophosphamide with/without doxorubicin chemotherapy for 4 cycles. The primary objective was to evaluate the non-inferiority of MW05 to standard PEG-rhG-CSF in duration of severe neutropenia (DSN; Grade 4) in cycle 1.

Results

Eligible patients were randomized to the groups(MW05, n=328; PEG-rhG-CSF, n=164). In cycle 1, the mean DSN was 0.24 days for MW05 and 0.25 days for PEG-rhG-CSF, and the mean difference of DSN[−0.02(95%CI: -0.12, 0.08)days] met the primary endpoint of non-inferiority. In cycle 2-4, the results of DSN were consistent with cycle 1. The incidence of Grade 4 neutropenia in MW05 group was lower than that in PEG-rhG-CSF group, representing 16.5%, 3.0%, 2.7%, 3.4% for MW05 and 19.5%, 9.8%, 6.7%, 6.1% for PEG-rhG-CSF in chemotherapy cycle 1-4 respectively. The incidence of febrile neutropenia(FN) across all cycles was numerically low and not significantly different between two groups, with 7 patients (2.1%) in MW05 group and 6 patients (3.7%) in PEG-rhG-CSF group. Other efficacy endpoints and adverse events results were comparable between two groups. There was 1 death during the study, which was not related to study drug treatment.

Conclusions

These results demonstrate non-inferiority and comparable safety for MW05 versus PEG-rhG-CSF. As a novel, long-acting rhG-CSF modified with HSA, MW05 can effectively shorten DSN induced by chemotherapy and may reduce the incidence of FN and severe neutropenia.

Clinical trial identification

NCT04554056.

Editorial acknowledgement

Legal entity responsible for the study

Mabwell (Shanghai) Bioscience Co., Ltd.

Funding

Mabwell (Shanghai) Bioscience Co., Ltd.

Disclosure

P. Wang: Financial Interests, Personal, Full or part-time Employment: Mabwell (Shanghai) Bioscience Co., Ltd. All other authors have declared no conflicts of interest.