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). This pegylated form of the human granulocyte colony stimulating factor (G-CSF) analogue filgrastim. This granulocyte colony-stimulating factor (G-CSF) receptor agonist is used to stimulate bone marrow to produce more neutrophils to decrease the incidence of infections in patients undergoing chemotherapy. It 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 single-dose, randomized, double-blind, cross-over study enrolled 172 healthy volunteers in Germany. It primarily investigated PK and PD of B12019 compared to Neulasta®.
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 December 2, 2016, Cinfa Biotech announced that an abstract has been published at the 58th Annual Meeting of the American Society of Hematology (“Demonstration of Pharmacokinetic and Pharmacodynamic Equivalence in Healthy Volunteers for B12019, a New Proposed Pegfilgrastim Biosimilar” -Abstract 5079 ). This abstract reports further data from a clinical trial evaluating pharmacokinetic (PK) and pharmacodynamics (PD) equivalence of its lead development candidate B12019, a biosimilar version of Neulasta® (pegfilgrastim) to treat chemotherapy-induced neutropenia.
- The study met all of its primary endpoints for pharmacokinetics: Area Under the Curve for concentration (AUC0-last) and Cmax; plus pharmacodynamics (PD): Absolute Neutrophil Count (ANC) and Area Under the Effect Curve (AUEC). For all endpoints, the Confidence Intervals (CI) for the Geometric Mean Ratio (GMR) were well contained within the pre-specified margins of 80 to 125%.
- The safety profile of B12019 did not show any clinically meaningful difference as compared to Neulasta®. Neither anti-G-CSF nor neutralising antibodies were detected for both, B12019 and Neulasta®.
- • On July 4, 2016, Cinfa Biotech announced positive top-line data from a clinical trial with B12019. The primary endpoints of the trial, to demonstrate the pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of B12019 with the originator product, were met. The single-dose, randomized, double-blind, cross-over study enrolled 172 healthy volunteers in Germany. Safety, tolerability and immunogenicity of the biosimilar candidate and Neulasta® were comparable. Further data from the trial will be presented at upcoming scientific conferences. Cinfa's development strategy includes a second clinical study to investigate the immunogenicity of B12019.
- • On November 16, 2015, Cinfa Biotech announced that the first subjects have been dosed in a clinical trial of B12019, a biosimilar version of Neulasta® (pegfilgrastim) to treat chemotherapy induced neutropenia. This trial is the first part of a clinical development program investigating the clinical comparability of B12019. The single dose, cross-over study will enrol up to 170 healthy volunteers in Germany. It primarily investigates the pharmacokinetics (PK) and the pharmacodynamics (PD) of B12019 as compared to Neulasta®. The study design is based on scientific advice from the European Medicines Agency (EMA) and is tailored to the specific properties of pegfilgrastim.
Is
general: Yes
