Abstract 1730
Background
Granulocyte colony-stimulating factors (G-CSFs), including filgrastim and its long-acting form pegfilgrastim, are widely used to prevent chemotherapy-induced neutropenia in patients undergoing cytotoxic chemotherapy. Bone pain is the most frequently reported adverse event (AE) associated with G-CSF. In cancer patients receiving pegfilgrastim, bone pain incidence ranges from 25–38%, compared with 52–84% in healthy volunteers (HVs).1 This study compares safety data for Sandoz proposed biosimilar pegfilgrastim in Phase I and III studies.
Methods
Three studies were included: 103, a single-dose, randomized, double-blind, crossover phase I study in HVs receiving proposed biosimilar (n = 92) or reference pegfilgrastim (n = 92)2 and 2 randomized, double-blind Phase III confirmatory studies (PROTECT13 and 24) in breast cancer (BC) patients undergoing cytotoxic chemotherapy (≤6 cycles) receiving proposed biosimilar (PROTECT1: n = 159; PROTECT2: n = 155) or reference pegfilgrastim (PROTECT1: n = 157; PROTECT2: n = 153). Results were compared for a single dose of pegfilgrastim in 103, and for 1st treatment cycle in PROTECT1 and 2.
Results
Differences in baseline characteristics between 103 and PROTECT included younger age, lower BMI and inclusion of men in 103 (Table). Treatment related bone pain was reported by 58% (biosimilar) and 53% (reference) in 103; in 4.4% (biosimilar) and 5.1% (reference) in PROTECT1, and 4.5% (biosimilar) and 8.5% (reference) in PROTECT2. AEs were generally mild in 103 and mild/moderate in PROTECT.Table: 1698P
| Study 1032 | PROTECT12 | PROTECT23 | |
|---|---|---|---|
Baseline characteristics | |||
Age, mean (SD) | |||
Proposed biosimilar | 26.7 (7.35) | 49.9 (9.53) | 48.8 (10.50) |
Reference | 50.5 (10.87) | 49.1 (10.07) | |
Female gender, n (%) | |||
Proposed biosimilar | 67 (36) | 159 (100) | 155 (100) |
Reference | 157 (100) | 153 (100) | |
BMI, mean (SD) | |||
Proposed biosimilar | 23.9 (2.17) | 27.5 (5.67) | 26.6 (5.77) |
Reference | 27.4 (5.60) | 26.5 (5.13) | |
Safety | |||
Bone pain, n (%) | |||
Proposed biosimilar | 102 (58) | 7 (4.4) | 7 (4.5) |
Reference | 94 (53) | 6 (3.8) | 13 (8.5) |
RR (CI) | 1.10 (0.93 - 1.30) | 1.15 (0.40 - 3.35) | 0.53 (0.22 -1.30) |
Headache, n (%) | |||
Proposed biosimilar | 100 (57) | 2 (1.3) | 3 (1.9) |
Reference | 99 (56) | 3 (1.9) | 3 (2.0) |
RR (CI) | 1.02 (0.87 - 1.20) | 0.66 (0.11 - 3.89) | 0.99 (0.20 - 4.81) |
BMI, body mass index; CI, confidence interval; RR, relative risk; SD, standard deviation.
Conclusions
Bone pain was similar with proposed biosimilar and reference pegfilgrastim, in studies of BC patients and HVs. Pivotal Phase I and Phase III studies support the matching safety and efficacy of Sandoz proposed biosimilar and reference pegfilgrastim. References: 1. Lambertini et al Crit Rev Oncol Hematol 2014;89:112–28. 2. Nakov et al Cancer Res 2018;78:P3-14-10. 3. Harbeck et al Future Oncol 2016;12:1359–7. 4. Blackwell et al Oncologist 2016;21:789–4.
Clinical trial identification
Legal entity responsible for the study
Hexal AG, Holzkirchen, Germany.
Funding
Hexal AG, Holzkirchen, Germany.
Editorial Acknowledgement
Caroline McGown, Spirit Medical Communications.
Disclosure
N. Harbeck: Advisory and consulting services: Amgen, Hexal. AG. J. Wang: Employee: Sandoz Inc. G. Otto, A. Krendyukov: Employee: Hexal AG.
Resources from the same session
2595 - Real-Life Utilization of Genomic testing for invasive Breast Cancer patients in Italy and France reduces Chemotherapy Recommendations
Presenter: Sandro Barni
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
2343 - Benefit of adjuvant chemotherapy in hormone receptor-positive, HER2-negative, invasive lobular carcinoma of the breast
Presenter: Alexandre De Nonneville
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
2990 - Baseline lymphocyte counts predict distant recurrence in early breast cancer
Presenter: Gun Min Kim
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
4532 - A propensity score analysis exploring the impact of the addition of adjuvant chemotherapy (aCT) to hormone therapy (aHT) in a multi-center series of resected luminal early stage pure Invasive Lobular Breast Carcinoma (ILC).
Presenter: Luisa Carbognin
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
2344 - Benefit of Adjuvant Systemic Therapies in HR+ HER2- pT1ab Node-Negative Breast Carcinomas
Presenter: Alexandre De Nonneville
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
3525 - Anti-proliferative effect of oral metronomic vinorelbine in PAM50 Luminal/HER2-negative early breast cancer (SOLTI-1501 VENTANA): an open-label, randomized, three-arm, multicenter, window-of-opportunity study
Presenter: Aleix Prat
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
3908 - Clinicopathologic significance of androgen receptor expression and discordant receptor status during progression in breast cancer
Presenter: Chan Heun Park
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
4075 - The outcomes of early breast cancers utilizing the Oncotype Dx Recurrence score (RS) instead of Clinico-pathological (CP) factors for prognostic risk assessment: A Single Institution Experience
Presenter: Adhar Alsayed
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
738 - Circulating tumor cells as a prognostic marker in non metastatic breast cancer patients.
Presenter: Summar Elmorshidy
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
3151 - Molecular subtyping of breast cancer by dedicated breast PET
Presenter: Satoshi Sueoka
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