Lonquex (lipegfilgrastim biosimilar)

G-CSF type used in mobilization and mobilization capacity were found to correlate with viable CD34 cell loss during processing and storage. Most importantly, low infused viable CD34 cell count did not seem to impact on PFS or OS.

Targeted gene expression complements flow cytometry analysis to provide a comprehensive understanding of the effects of FFX-Lipeg. Flow cytometry and targeted gene expression showed increases in neutrophils and monocytes after FFX-Lipeg. The number of lymphocytes is increased after treatment; nevertheless, their cell-specific gene expression levels are downregulated. This highlights that different techniques influence clinical discoveries. Therefore, it is important to carefully select the measurement technique used to study the effect of a treatment.

For patients with breast cancer, lipegfilgrastim 6 mg and eflapegrastim 13.2 mg might be the most effective regimen among LA-G-CSFs. Higher doses of LA-G-CSF may enhance efficacy without causing additional SAEs.

Overall, 314 adverse events (AEs) were reported from 107 patients and 27 serious AEs from 21 patients. None of the SAEs was "fatal," and CTCAE grade was mostly (89.6%) assessed as "1" or "2." According to the treating physicians, 99.3% of all patients benefitted from lipegfilgrastim prophylaxis, and tolerability was mostly rated "very good" or "good." These results suggest that primary lipegfilgrastim prophylaxis is effective and safe in clinical routine and is beneficial in primary breast cancer patients undergoing dd/idd-ETC CTx.

Twenty-three patients underwent ASCT following high dose melphalan. All patients engrafted. As lipegfilgrastim is administered only once, it is conceivable that it improves both compliance and quality-of-life (NCT02488382).

The mobilization of blood grafts with LIPEG added to chemotherapy was associated with higher CD34 cell apheresis yields than with PEG. A randomized study is warranted to verify these findings.