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

• Published in: Pharmacology research & perspectives Vol. 9; no. 4; pp. e00839 - n/a
• Main Authors: Demarchi, Martin, Coliat, Pierre, Mclendon, Kristi, Chung Shii Hii, Jocelyn, Feyaerts, Peggy, Ang, Felicia, Jaison, Litha, Deforce, Filip, Derde, Marie Paule, Kim, Michael Jinwoo, Park, Lisa Soyeon, Detappe, Alexandre, Pivot, Xavier
• Format: Journal Article
• Language: English
• Published: United States John Wiley & Sons, Inc 01.08.2021; John Wiley and Sons Inc; Wiley
• Subjects: Adolescent; Adult; Antibodies; Antibodies - blood; Antineoplastic Agents, Immunological - immunology; Antineoplastic Agents, Immunological - pharmacokinetics; Area Under Curve; Bioequivalence; Biological products; biosimilar; Biosimilar Pharmaceuticals - pharmacokinetics; Breast cancer; Confidence intervals; Double-Blind Method; Double-blind studies; Drug dosages; Epidermal growth factor; FDA approval; Healthy Volunteers; Humans; Infusions, Intravenous; Male; Middle Aged; Monoclonal antibodies; Original; pharmacokinetic; Pharmacokinetics; Pharmacology; Statistical analysis; trastuzumab; Trastuzumab - immunology; Trastuzumab - pharmacokinetics; Ultrasonic imaging; Values; Variance analysis; Young Adult; United States > US; Singapore; trastuzumab; pharmacokinetic; biosimilar
• ISSN: 2052-1707; 2052-1707
• DOI: 10.1002/prp2.839

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 AUC0–inf and secondary PK endpoints, AUC0–last and Cmax 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 AUC0–inf, Cmax and AUC0–last, 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. 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.