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E-Poster Display

287P - Efficacy, safety and pharmacokinetics of a proposed trastuzumab biosimilar HLX02 compared with trastuzumab in metastatic breast cancer: A global phase III study

Date

17 Sep 2020

Session

E-Poster Display

Topics

Immunotherapy

Tumour Site

Breast Cancer

Presenters

Qingyuan Zhang

Citation

Annals of Oncology (2020) 31 (suppl_4): S348-S395. 10.1016/annonc/annonc268

Authors

Q. Zhang1, B. Xu2, T. Sun3, W. Li4, Y. Teng5, X. Hu6, I. Bondarenko7, H. Adamchuk8, Y. Li9, B. Shan9, S. Liu10, W. Jiang10, X. Zhang9, A. Luk9, K. Chai11

Author affiliations

  • 1 Medical Oncology, Harbin Medical University Cancer Hospital, 150000 - Harbin/CN
  • 2 Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 100021 - Beijing/CN
  • 3 Breast Cancer Center, Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute,, 110042 - Shenyang/CN
  • 4 Cancer Center, The First Hospital of Jilin University, 130021 - Changchun/CN
  • 5 Medical Oncology, The First Hospital of China Medical University, 110122 - Shenyang/CN
  • 6 Medical Oncology, Fudan University Shanghai Cancer Center, 200032 - Shanghai/CN
  • 7 Oncology, Communal Institution Dnipropetrovsk City Multifield Clinical Hospital, Dnipropetrovsk Oblast/UA
  • 8 Chemotherapy Department, Communal Institution Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council, 50048 - Kryvyi Rih/UA
  • 9 Global Clinical Medical Affairs, Shanghai Henlius Biotech, Inc., Shanghai/CN
  • 10 Executive Office, Shanghai Henlius Biotech, Inc., Shanghai/CN
  • 11 Global Clinical Medical Affairs, Shanghai Henlius Biotech, Inc., 200233 - Shanghai/CN

Resources

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Abstract 287P

Background

HLX02 is a first CN-manufactured TZB biosimilar investigated in a global setting followed stringent biosimilar development guideline to increase patient accessibility worldwide. The confirmatory phase III study was aimed to evaluate equivalence in safety and efficacy of HLX02 and reference TZB in metastatic breast cancer (mBC) pts. Here we report the updates of efficacy and safety data up to 12 months and the PopPK model. The primary endpoints ORRwk24 was previously reported at ESMO 2019.

Methods

This is a multicountry, multicenter, randomized, double-blind, parallel-controlled equivalence study (HLX02-BC01). Eligible female pts were recruited and randomized at a 1:1 ratio to receive an IV dose 8mg/kg of HLX02 or EU-TZB combined with docetaxel on Day 1 followed by 6mg/kg in 3-week cycle up to 12 month. The primary endpoint was ORRwk24. The PopPK model was developed with the data collected from Ph1 and Ph3 study of HLX02 and reference TZBs (US- and EU-) in 754 subjects including healthy volunteers and previously untreated HER2+ mBC (serum sample=5882) pts using FOCEI method in non-linear mixed-effect modeling (NONMEM). Suitable covariates were selected using a forward addition and backward elimination method based on the significance levels of p<0.01 and p<0.001.

Results

The ORR was 71.3% (n=324) in HLX02 and 71.4% (n=325) in EU-TZB with the group difference of -0.1%, whose 95% CI (-7.0%, 6.9%) fell completely within the pre-defined equivalence margins of ±13.5%. No statistical difference was observed between 2 treatment groups in all secondary efficacy analyses (CBR, DCR, DoR, PFS and OS) up to 12 months. Safety outcomes and immunogenicity were similar. No significant difference was observed in steady state exposures (≤13% for AUCss and Cmax,ss) between HXL02 and TZBs in PopPK model. Covariates (e.g body weight) have influence on PK exposure show similarity between HLX02 and TZBs.

Conclusions

Based on the evidence of equivalent efficacy, safety and PK of HLX02 and reference TZBs in HER2+ mBC pts resulted from phase III trial and popPK model, HLX02 possesses the potential to provide alternative treatment option for pts globally.

Clinical trial identification

HLX02 phase I study: NCT02581748; HLX02 phase III study: NCT03084237.

Editorial acknowledgement

Legal entity responsible for the study

Shanghai Henlius Biotech, Inc.

Funding

Shanghai Henlius Biotech, Inc.

Disclosure

Y. Li: Full/Part-time employment: Shanghai Henlius Biotech, Inc.. B. Shan: Full/Part-time employment: Shanghai Henlius Biotech, Inc.. S. Liu: Shareholder/Stockholder/Stock options, Officer/Board of Directors: Shanghai Henlius Biotech, Inc. W. Jiang: Shareholder/Stockholder/Stock options, Full/Part-time employment: Shanghai Henlius Biotech, Inc. X. Zhang: Full/Part-time employment: Shanghai Henlius Biotech, Inc. A. Luk: Full/Part-time employment: Shanghai Henlius Biotech, Inc. K. Chai: Full/Part-time employment: Shanghai Henlius Biotech, Inc. All other authors have declared no conflicts of interest.

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