A randomized, double-blind, parallel control study to evaluate the biosimilarity of QL1209 with Perjeta® in healthy male subjects

Yuanyuan Sun; Heng Yang; Xiaoyan Yang; Shuang Yang; Can Guo; Honghui Chen; Chang Cui; Yuxia Xiang; Guoping Yang; Jie Huang

doi:10.3389/fphar.2022.953641

A randomized, double-blind, parallel control study to evaluate the biosimilarity of QL1209 with Perjeta^® in healthy male subjects

Front Pharmacol. 2022 Aug 23:13:953641. doi: 10.3389/fphar.2022.953641. eCollection 2022.

Authors

Yuanyuan Sun¹, Heng Yang², Xiaoyan Yang¹, Shuang Yang¹, Can Guo¹, Honghui Chen¹, Chang Cui¹, Yuxia Xiang¹, Guoping Yang^{1

3

4

5

6}, Jie Huang¹

Affiliations

¹ Center of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, China.
² Department of Neurology, The Third Xiangya Hospital of Central South University, Changsha, China.
³ Research Center of Drug Clinical Evaluation of Central South University, Changsha, China.
⁴ Department of Pharmacy, The Third Xiangya Hospital, Central South University, Changsha, China.
⁵ Xiangya School of Pharmaceutical Sciences, Central South University, Changsha, China.
⁶ National-Local Joint Engineering Laboratory of Drug Clinical Evaluation Technology, Changsha, China.

Abstract

Purpose: This is the first study to compare the pharmacokinetics, safety and, immunogenicity of QL1209, a biosimilar of Perjeta^®. Methods: This study was a randomized, double-blind, parallel-controlled clinical trial evaluating the biosimilarity between QL1209 (specification: 420 mg:14 ml, single use via, manufacturer: Qilu Pharmaceutical Co., Ltd., batch number: 201808001KJL) and Perjeta^® (specification: 420 mg: 14 ml, single use via, manufacturer: Roche Pharma AG, batch number: H0309H02). The trial period was 99 days (blood samples for PK were collected 99 days after infusion). Serum concentrations were determined using a validated assay. PK parameters were calculated using a non-compartmental model and analyzed statistically. Anti-drug antibody (ADA)-positive samples were further tested for the presence of neutralization antibody detection (NAb). Results: A total of 137 healthy subjects were administrated. The subjects were randomized 1:1 to receive QL1209 or Perjeta^® 420 mg intravenously. The geometric mean ratio (GMRs) for QL1209 versus Perjeta^® are 104.14%, 104.09%, and 110.59% for C_max, AUC_0-t, and AUC_0-∞, respectively, and their 90% confidence interval (CIs) all fell within the predefined bioequivalence margin 80.00-125%. The incidence of drug-related adverse events was 95.6% and 95.5% in the QL1209 and Perjeta^® groups, respectively, also comparable between the two groups. Conclusion: The results of this comparative clinical pharmacology study demonstrated the PK similarity of QL1209 (420 mg: 14 ml) and Perjeta^® (420 mg: 14 ml) and there was no significant difference in safety and immunogenicity between QL1209 and Perjeta^® manufactured by Roche Pharma AG.

Keywords: QL1209; biosimilar; immunogenicity; pertuzumab; pharmacokinetics; safety.