441P - The prophylactic efficacy of telpegfilgrastim, a Y-shape branched pegylated G-CSF in patient with chemotherapy-induced neutropenia: A multicenter, randomized phase III study

Background

Recombinant human granulocyte colony stimulating factor (rhG-CSF) and its long-acting pegylated form (PEG-rhG-CSF) are the important drugs for the management of chemotherapy induced neutropenia (CIN). This study was to evaluate the efficacy and safety of telpegfilgrastim, a Y-shape branched pegylated G-CSF for the prophylaxis of CIN.

Methods

This randomized, open label, positive drug controlled phase III study enrolled patients with breast cancer (BC) or with non–small cell lung cancer (NSCLC) who received 1-4 chemotherapy cycles, 21 days per cycle. According to tumor type, patients were separately randomized (1:1:1) to receive a single subcutaneous injection of 2 mg telpegfilgrastim (group 1), 33 μg/kg telpegfilgrastim (group 2), or positive drugs (control group) per cycle. Patients in control group received daily rhG-CSF（Topneuter®） 5μg/kg at first cycle, then chose to take PEG-rhG-CSF（Xinruibai®） 6 mg or the same treatment with the 1st cycle in cycle 2-4. The primary endpoint was the duration of grade 4 neutropenia in cycle 1.

Results

The full analysis set involved 397 patients (BC, n=265; NSCLC. n=132). Single dose of 2 mg or 33 μg/kg telpegfilgrastim was non-inferiority to rhG-CSF on the duration of grade 4 neutropenia in cycle 1, the least square means of the difference with control group in group 1 and group 2 were 0.097 (95% CI: -0.189, 0.383) and 0.217 (95% CI: -0.091, 0.524) days for BC, -0.143 (95% CI: -0.349, 0.064) and -0.059 (95% CI: -0.264, 0.146) for NSCLC.There was no significant difference between telpegfilgrastim treated group with control group regarding to all secondary efficacy endpoints and safety endpoint. The average exposure per cycle of telpegfilgrastim was similar to the cumulative exposure per cycle of rhG-CSF, and was 1/3 exposure dose of PEG-rhG-CSF.

Conclusions

Single dose of 2 mg or 33 μg/kg telpegfilgrastim per cycle was as tolerable and effective as multiple daily doses of the rhG-CSF and single dose of the PEG- rhG-CSF in prophylactic therapy of CIN. Telpegfilgrastim at a fixed single dose of 2 mg may be a more convenient mode of administration.

Clinical trial identification

NCT04466137.

Editorial acknowledgement

The editorial assistance was provided by Liangjie Zhong from Fosun Pharma.

Legal entity responsible for the study

Xiamen Amoytop Biotech Co., LTD.

Funding

Xiamen Amoytop Biotech Co., LTD. China National Major Project for New Drug Innovation 2008ZX09312, 2012ZX09303012-001 and 2017ZX09304015.

Disclosure

L. Sun: Other, Personal, Full or part-time Employment: Xiamen Amoytop Biotech Co., LTD. All other authors have declared no conflicts of interest.