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TROIKA-1: A double-blind, randomized, parallel group, study aimed to demonstrate the equivalent pharmacokinetic profile of HD201, a potential biosimilar candidate to trastuzumab, versus EU-Herceptin® and US-Herceptin® in healthy male subjects.
Demarchi M, Coliat P, Mclendon K, Chung Shii Hii J, Feyaerts P, Ang F, Jaison L, Deforce F, Derde MP, Kim MJ, Park LS, Detappe A, Pivot X. Demarchi M, et al. Among authors: feyaerts p. Pharmacol Res Perspect. 2021 Aug;9(4):e00839. doi: 10.1002/prp2.839. Pharmacol Res Perspect. 2021. PMID: 34309241 Free PMC article. Clinical Trial.
A randomized phase I study comparing the pharmacokinetics of a bevacizumab (HD204) biosimilar to European Union- and United States of America-sourced bevacizumab.
Demarchi M, Coliat P, Barthelemy P, Schott R, BenAbdelghani M, Kim M, Hii JCS, Feyaerts P, Ang FRX, Derde MP, Deforce F, Petit T, Schwabe C, Wynne C, Park LS, Pivot X. Demarchi M, et al. Among authors: feyaerts p. PLoS One. 2021 Sep 23;16(9):e0248222. doi: 10.1371/journal.pone.0248222. eCollection 2021. PLoS One. 2021. PMID: 34555031 Free PMC article. Clinical Trial.
Efficacy of HD201 vs Referent Trastuzumab in Patients With ERBB2-Positive Breast Cancer Treated in the Neoadjuvant Setting: A Multicenter Phase 3 Randomized Clinical Trial.
Pivot X, Georgievich MA, Shamrai V, Dzagnidze G, Soo Hoo HF, Kaewkangsadan V, Petrelli F, Villanueva C, Nikolaevich LO, Hii J, Kim J, Pradhan S, Jaison L, Feyaerts P, Kaufman L, Derde MP, Bonamy GMC, Deforce F, Cox DG. Pivot X, et al. Among authors: feyaerts p. JAMA Oncol. 2022 May 1;8(5):698-705. doi: 10.1001/jamaoncol.2021.8171. JAMA Oncol. 2022. PMID: 35238873 Free PMC article. Clinical Trial.
Final analysis of the phase 3 randomized clinical trial comparing HD201 vs. referent trastuzumab in patients with ERBB2-positive breast cancer treated in the neoadjuvant setting.
Pivot X, Manikhas AG, Shamrai V, Dzagnidze G, Soo Hoo HF, Kaewkangsadan V, Petrelli F, Villanueva C, Kim J, Pradhan S, Jaison L, Feyaerts P, Kaufman L, Derde MP, Deforce F, Cox DG. Pivot X, et al. Among authors: feyaerts p. BMC Cancer. 2023 Jan 31;23(1):112. doi: 10.1186/s12885-023-10574-2. BMC Cancer. 2023. PMID: 36721174 Free PMC article. Clinical Trial.