Tony Hagen is senior managing editor for The Center for Biosimilars®.
Singapore-based PrestigePharma presents fresh equivalency data supporting its case for regulatory approval of HD201.
Positive pharmacokinetic (PK) equivalency data were presented for PrestigePharma’s trastuzumab biosimilar candidate (HD201, Tuznue), at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.
PrestigePharma is a Singapore-based biopharmaceutical company that has an application for HD201 under review with the European Medicines Agency. The company previously reported positive biosimilarity findings for HD201 at ASCO20 Virtual, the annual meeting of the American Society of Clinical Oncology.
In the ESMO data, PrestigePharma reported PK equivalence between HD201 and 2 versions of the reference product sold in the United States (US-Herceptin) and Europe (EU Herceptin), based on findings from a randomized, phase 1 trial (TROIKA-I, NCT03776240). Investigators said 105 healthy male subjects randomized to 3 arms received the biosimilar candidate and reference versions at an intravenous dose of 6 mg/kg for 90 minutes.
Study End Points
The HD201 and Herceptin trastuzumab versions were compared based on primary end points including peak concentration and total drug exposure. PK equivalence for HD201 was considered met if the confidence intervals were within conventional equivalence margins of 80% and 125%. Secondary end points included other PK parameters, safety, tolerability, and immunogenicity.
Investigators said HD201 demonstrated PK equivalence for all criteria. They said the incidence of adverse events was lower in the HD201 cohort (20%) compared with the EU Herceptin (34.3%) and US-Herceptin (31.4%) groups. The most common adverse events were infusion-related reactions and administration site reactions.
At ASCO, findings were presented from TROIKA-I and TROIKA, which involved patients with HER2-positive early stage breast cancer. These earlier results indicated that the biosimilar was safe and well tolerated with PK comparable to Herceptin. In TROIKA, patients received HD201 or EU-Herceptin with chemotherapy in the neoadjuvant setting followed by trastuzumab monotherapy in the adjuvant phase.
The total pathological complete response rate was 46.6% for patients in the HD201 arm versus 46.2% in the Herceptin arm. The overall response rate was 90.8% vs 89.4%, respectively. TROIKA had 574 patents evaluable for response for the ASCO report, and the study remains ongoing (NCT03013504).
HD201 is the lead biosimilar candidate under development at PrestigePharma. The company also has bevacizumab and adalimumab biosimilars in development.
Demarchi M, Coliat P, Chung Shii Hii J, et al. A double-blind, randomized, parallel group study to demonstrate the equivalent pharmacokinetic properties of a single intravenous dose HD201, a trastuzumab biosimilar candidate, versus EU trastuzumab and US trastuzumab. Poster presented at ESMO Virtual Congress 2020; September 17, 2020. Abstract 590P.