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Efficacy, Safety, and Immunogenicity of HLX02 Compared with Reference Trastuzumab in Patients with Recurrent or Metastatic HER2-Positive Breast Cancer: A Randomized Phase III Equivalence Trial.
Xu, Binghe; Zhang, Qingyuan; Sun, Tao; Li, Wei; Teng, Yue'e; Hu, Xichun; Bondarenko, Igor; Adamchuk, Hryhoriy; Zhang, Liangming; Trukhin, Dmytro; Wang, Shusen; Zheng, Hong; Tong, Zhongsheng; Shparyk, Yaroslav; Wang, Qingyu.
Afiliação
  • Xu B; Department of Medical Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 17, Panjiayuan Nanli, Beijing, 100021, China. xubinghe@medmail.com.cn.
  • Zhang Q; Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China.
  • Sun T; Internal Medicine Oncology, Liaoning Cancer Hospital, Liaoning, China.
  • Li W; Internal Medicine Oncology, The First Hospital of Jilin University, Jilin, China.
  • Teng Y; Internal Medicine Oncology, The First Hospital of China Medical University, Shenyang, China.
  • Hu X; Internal Medicine Oncology, Shanghai Cancer Hospital, Fudan University, Shanghai, China.
  • Bondarenko I; Chemotherapy Department, Communal Institution Dnipropetrovsk City Multifield Clinical Hospital, Dnipro, Ukraine.
  • Adamchuk H; Chemotherapy Department, Communal Institution Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council, Kryvyi Rih, Ukraine.
  • Zhang L; Internal Medicine Oncology, Yantai Yuhuangding Hospital, Yantai, Shandong, China.
  • Trukhin D; Daystay Care of Dispensary and Policlinic Department, Communal Institution Odesa Regional Oncological Dispensary, Odesa, Ukraine.
  • Wang S; Internal Medicine Oncology, Cancer Center, Sun Yat-Sen University, Guangzhou, China.
  • Zheng H; Internal Medicine Oncology, West China Hospital, Sichuan University, Sichuan, China.
  • Tong Z; Internal Medicine Oncology, Tianjin Cancer Hospital, Tianjin, China.
  • Shparyk Y; CI of LRC Lviv Oncological Regional Treatment and Diagnostic Center, Lviv, Ukraine.
  • Wang Q; Shanghai Henlius Biotech, Inc., Shanghai, China.
BioDrugs ; 35(3): 337-350, 2021 May.
Article em En | MEDLINE | ID: mdl-33826080
Trastuzumab is a biologic drug used to treat patients with certain types of breast cancer and stomach cancer. Biosimilars are medications that are almost identical to and indistinguishable from original biologic drugs but usually less expensive and more accessible. The main purpose of this study was to evaluate the efficacy (treatment effects) of HLX02 (trastuzumab biosimilar) compared with reference trastuzumab in patients with human epidermal growth factor receptor 2 (HER2)-positive recurrent or metastatic breast cancer. Other objectives were to evaluate the safety of HLX02 by monitoring adverse events and assessing its potential to induce antibody production (which can prevent a drug from being effective). Patients with HER2-positive recurrent or metastatic breast cancer were randomly allocated to receive HLX02 (n = 324) or European Union (EU)-sourced trastuzumab (n = 325). Study drugs (HLX02 or EU-trastuzumab) were given intravenously, with an initial dose of 8 mg/kg, followed by 6 mg/kg every 3 weeks for up to 12 months. Statistical analyses showed that HLX02 was equivalent to trastuzumab in efficacy evaluations. Adverse events observed in the HLX02 treatment group were consistent with those seen with trastuzumab in the current and previous clinical studies. Additionally, no statistically significant differences were seen in the tendency to stimulate antibody production between the two study drugs. To conclude, HLX02 and reference trastuzumab had similar efficacy and safety profiles. These data support the approval of HLX02 as a trastuzumab biosimilar.
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Neoplasias da Mama Tipo de estudo: Clinical_trials Limite: Humans País/Região como assunto: Europa Idioma: En Revista: BioDrugs Assunto da revista: ALERGIA E IMUNOLOGIA / GENETICA MEDICA / TERAPEUTICA / TERAPIA POR MEDICAMENTOS Ano de publicação: 2021 Tipo de documento: Article País de afiliação: China País de publicação: Nova Zelândia

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Neoplasias da Mama Tipo de estudo: Clinical_trials Limite: Humans País/Região como assunto: Europa Idioma: En Revista: BioDrugs Assunto da revista: ALERGIA E IMUNOLOGIA / GENETICA MEDICA / TERAPEUTICA / TERAPIA POR MEDICAMENTOS Ano de publicação: 2021 Tipo de documento: Article País de afiliação: China País de publicação: Nova Zelândia