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.

Fiche publication

Date publication

août 2021

Journal

Pharmacology research & perspectives

Auteurs

Membres identifiés du Cancéropôle Est :
Pr PIVOT Xavier , Dr DETAPPE Alexandre , Dr DEMARCHI Martin , Dr COLIAT Pierre

Tous les auteurs :
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

Lien Pubmed

https://www.ncbi.nlm.nih.gov/pubmed/34309241

Résumé

Prestige Biopharma Ltd (Singapore) has developed HD201, a proposed biosimilar to reference product trastuzumab. As a part of the stepwise approach to ensure comparability between the biosimilar candidate and the reference medicinal product, a phase I study in healthy subjects was conducted to demonstrate the pharmacokinetic (PK) equivalence (NCT03776240). The primary objective of the study was to demonstrate (PK) equivalence of HD201, EU-Herceptin , and US-Herceptin given at 6 mg/kg as a 90-min i.v. infusion to healthy male subjects. A pairwise comparisons based on the primary endpoint AUC and secondary PK endpoints, AUC and C were undertaken. PK equivalence was to be concluded if the 90% confidence interval (CI) for the ratio of geometric means for each criterion were within the equivalence margin of 80% to 125%. Secondary objectives included assessment of other PK parameters, safety, tolerability, and immunogenicity in the three arms. A total of 105 healthy male subjects (35/treatment) were randomized in this study. The 90% CI for the ratios of AUC , C and AUC , were within 80%-125% for the comparisons of HD201 to EU-Herceptin or US-Herceptin and EU-Herceptin to US-Herceptin . The frequency of subjects with TEAEs of special interest was slightly lower in the HD201 group (20.0%) compared to the other treatment groups (EU-Herceptin : 34.3%; US-Herceptin : 31.4%). Only 1 subject (EU-Herceptin group) developed anti-drug antibodies prior to dosing. Overall, HD201 demonstrates PK similarity to both EU-Herceptin and US-Herceptin . The three study drugs also demonstrated similar safety profiles.