1624 - Next and Venice: Design of two Multicentre, Phase IV, Prospective, Longitudinal Studies Evaluating The Safety Profile of a Biosimilar Filgrastim in Patients Treated with Cytotoxic Chemotherapy

Abstract

ABSTRACT Introduction Nivestim™ is a European Union (EU)-licensed biosimilar filgrastim used in the treatment of chemotherapy-induced neutropenia and febrile neutropenia. Nivestim™ has similar pharmacokinetic and pharmacodynamic properties to its reference compound Neupogen®, and has demonstrated equivalent safety and efficacy in clinical trials. However, the safety of biosimilars in general is closely scrutinised. We present designs for two observational phase IV studies that will examine the safety profile of prophylactic and curative Nivestim™ in patients treated with cytotoxic chemotherapy in real-world clinical-practice. Method NEXT (Tolerance de Nivestim™ chez les patients traites par une chimiotherapie anticancereuse cytotoXique en praTique courante) and VENICE (VErtraglichkeit von NIvestim™ unter zytotoxischer Chemotherapie in der Behandlung malinger Erkrankungen) are multicentre, prospective, longitudinal, observational studies that aim to monitor 2000 adult and 700 adult and paediatric patients respectively 12 months. The primary objective of the studies is to assess the safety of Nivestim™ in patients undergoing cytotoxic chemotherapy for malignancy through the evaluation of adverse events in all organ system classes, as required by EU pharmacovigilance guidelines. Secondary objectives include obtaining data on efficacy outcomes, lab values, patterns of use of Nivestim™, dose intensity, indications for treatment, patient characteristics, physician knowledge of filgrastim prescribing, and the reasons for choosing Nivestim™. VENICE will also include data on levels of CD34+ cells to assess predictive value as a marker of response. Data will be gathered over 3 patient visits: 1) inclusion visit, 2) first follow-up after first course of Nivestim™, and 3) second follow-up after completion of chemotherapy. Results Accrual figures as of 1 May 2012 are 630 (NEXT) and 136 (VENICE). Completion dates are June 2013 and June 2014 respectively. Conclusion Data from NEXT and VENICE will provide additional information on the long-term safety and efficacy of Nivestim™ in patients receiving cytotoxic chemotherapy in clinical practice. Disclosure S. Fruehauf: Receiving support from Hospira for the conduct of the VENICE study, C. Berthou: Receives support from Hospira for the conduct of the NEXT study, S. Lepretre: Receives support from Hospira for the conduct of the NEXT study, L. Cals: Received support from Hospira for the conduct of the NEXT study, F. Maloisel: Receive support from Hospira for the conduct of the NEXT study, D. Kamioner: Receives support from Hospira for the conduct of the NEXT study.