Date: 2017-09-05
Type of
information: Presentation of results at a congress
phase: 1
Announcement: presentation of results at the European Society for Medical Oncology (ESMO) Congress 2017
Company: Cinfa Biotech (Spain)
Product: B12019 - pegfilgrastim - biosimilar version of Neulasta®
Action
mechanism:
- protein/biosimilar. B12019, a biosimilar version of Neulasta® (pegfilgrastim), a pegylated form of the human granulocyte colony stimulating factor (G-CSF) analogue filgrastim. This granulocyte colony-stimulating factor (G-CSF) receptor agonist has been developed by Cinfa Biotech. The company was established by the spanish group Infarco in 2013 to build a pipeline of biosimilars for several indications in oncology and inflammatory diseases to address the growing need for affordable biologics therapies based on proven science, quality, safety and efficacy.
Disease: chemotherapy induced neutropenia.
Therapeutic
area: Cancer - Oncology
Country: Germany
Trial
details:
- The multiple-dose, randomised, double-blind, cross-over study will enrol 96 healthy volunteers in Germany. Secondary endpoints of the trial include pharmacokinetic (PK) and safety parameters. The study design is based on scientific advice from the European Medicines Agency (EMA) and is tailored to the specific properties of pegfilgrastim.
Latest
news:
- • On September 5, 2017, Cinfa Biotech reported further data of the clinical development program for its lead development candidate B12019, a biosimilar version of Neulasta® (pegfilgrastim) to treat chemotherapy-induced neutropenia, during a poster presentation at the European Society for Medical Oncology (ESMO) Congress 2017. (poster 1573P -“Pharmacokinetic and Pharmacodynamic Comparability of B12019, a Proposed Pegfilgrastim Biosimilar”). The pivotal study examined pharmacokinetic (PK) and pharmacodynamic (PD) comparability of 6 mg B12019 to 6 mg Neulasta®. The single-dose, randomised, double-blind, two-way cross-over study enrolled 172 healthy volunteers. The primary endpoints were the area under the plasma concentration-time curve (AUC) and the maximum concentration (Cmax) for PK and the area under the effect curve (AUEC) for absolute neutrophil count (ANC) for PD.
- The supportive study examined immunogenicity and PD comparability of 3 mg B12019 and 3 mg Neulasta® in a multiple-dose, randomised, double-blind, three-period, two-sequence cross-over study in 96 healthy volunteers. Primary endpoints were AUEC for PD and anti-drug antibody rate (ADA) for immunogenicity.
- All clinical endpoints were met in both studies.
- PK comparability was demonstrated in the pivotal study, and PD comparability was demonstrated in both studies. No imbalance of ADA-positive samples was observed and neither anti-G-CSF nor neutralising antibodies were detected for B12019 or Neulasta® in both studies. The clinical program confirmed the biosimilarity of B12019 and Neulasta® in highly sensitive clinical study settings, thereby verifying the high level of similarity as shown on bioanalytical level.
- • On May 17, 2017, Cinfa Biotech announced top-line data from the second clinical trial with its lead development candidate B12019. The trial demonstrated comparability of B12019 and its reference product Neulasta with regards to pharmacodynamics (PD) and immunogenicity. All primary and secondary study endpoints were met. Area under the effect curve (AUEC0-last) for PD and anti-drug antibody rate (ADA) for immunogenicity, confirming comparability to Neulasta. Likewise, all secondary endpoints were achieved. The safety of B12019 was also comparable to Neulasta. Further data from the trial will be presented at upcoming scientific conferences.
- • On September 26, 2016, Cinfa Biotech announced the start of the second clinical study with B12019. The objective of the trial is to investigate the pharmacodynamics (PD) and immunogenicity of B12019 compared to Neulasta®.
Is
general: Yes
