Abstract 3354
Background
Treatment with recombinant human granulocyte-colony stimulating factor (G-CSF) is an accepted standard for prevention of chemotherapy-induced neutropenia. RGB-02, a pegylated G-CSF (pegfilgrastim) developed by Gedeon Richter is a proposed biosimilar to the reference product Neulasta®. Therapy switch from a reference product to its biosimilar is expected to occur in the daily practice. Here we are presenting the outcome of treatment switch in two randomized cross-over design comparative PK/PD studies (EudraCT nr: 2011-001737-17 and 2016-005051-25) and a randomized, comparative, multicenter efficacy and safety study of RGB-02 (EudraCT nr: 2013-003166-14).
Methods
Efficacy, safety and PD data of two PK/PD studies (enrolling 110 and 150 healthy volunteers, respectively) and a comparative efficacy and safety study (enrolling 239 breast cancer patients) were analyzed in order to assess whether treatment switch from Neulasta® to RGB-02 has any impact on the PD response, efficacy or safety. The PK/PD studies had a cross-over design. Patients in the reference arm of the comparative efficacy and safety study were switched to RGB-02 treatment following the first two chemotherapy cycles. Endpoints assessed were related to the change in ANC count in healthy volunteers, duration of severe neutropenia (DSN; ANC < 0.5 x109/L) in the comparative efficacy and safety study, as well as safety data including immunogenicity collected in each clinical study.
Results
None of the PD endpoints showed any difference following the cross-over in the comparative PK/PD studies. The mean DSN values after the therapy switch were similar to the values prior to the switch and the switched arm (mean DSN: 0.6) did not show decreased efficacy compared to the arm received RGB-02 from the first cycle (mean DSN: 0.9). Safety results, including immunogenicity of the 3 studies did not reveal any negative impact of the treatment switch.
Conclusions
Treatment switch from Neulasta® to RGB-02 can be considered safe while maintaining the therapeutic effect of pegfilgrastim therapy.
Clinical trial identification
EudraCT: 2011-001737-17; EudraCT: 2016-005051-25; EudraCT: 2013-003166-14.
Legal entity responsible for the study
Gedeon Richter Plc.
Funding
Gedeon Richter Plc.
Editorial Acknowledgement
Disclosure
A. Illes L. Perjesi, K. Horvat-Karajz, N. Jeszenoi, I. Aradi: Employee: Gedeon Richter Plc. N.K. Singh, S.J. Mair, Z. Kahan: Principal investigator of one of the studies (EudraCT Nr. 2016-005051-25) sponsored by Gedeon Richter Plc; Investigator grant from the sponsor.
Resources from the same session
4942 - Analytical validation of OncoMasTR, a multigene test for predicting risk of distant recurrence in hormone receptor-positive early stage breast cancer
Presenter: Tony Loughman
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
5641 - Comparing the prognosis of favourable-histology breast cancers between younger women of less than 45 years of age at diagnosis with their older counterparts.
Presenter: Guek Eng Lee
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
4448 - TNBC universe: a monocentric retrospective analyses of TILs and AR as prognostic markers
Presenter: Agnese Losurdo
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
4755 - Genomic spectrum of Asian breast cancer based on targeted next-generation sequencing in 150 consecutive primary breast cancer
Presenter: Chihwan Cha
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
2741 - The Impact of the 21 Gene Recurrence Score (RS) on Chemotherapy (CHemoRx) Prescribing in Hormone Receptor (HR) Positive, Lymph Node Positive (LN+) Early-Stage Breast Cancer (BC) in Ireland: A National, Multi-centre, Prospective Study (CTRIAL-IE 15-34)
Presenter: Anees Hassan
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
3356 - Lymphocyte-predominant breast cancer has a significant lower mean of absolute neutrophil counts compared to non-lymphocyte-predominant breast cancer: Analyses with 576 cases
Presenter: Da Young Lee
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
4020 - Genetic Alterations of Early-Stage Breast Cancers by next-generation sequencing (NGS)
Presenter: Yan Xu
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
4924 - Oncotype Dx results in patients _40 years, Does age matters?: new insights
Presenter: Fernando Namuche
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
2646 - Impact of BRCA status on outcomes and survival in high-risk early breast cancers
Presenter: Elodie Klajer
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
4516 - Early breast cancer classified as intermediate risk by the Prosigna assay: Characteristics and treatment strategy
Presenter: Nawale Hajjaji
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract