The 2020 annual meeting of the European Society for Medical Oncology (ESMO) will be held on 19^th September to 18^th October. At this conference, Henlius released the updated multi-centre Phase 3 clinical study of Trastuzumab 汉曲优^Ⓡ (HLX02, EU brand name: Zercepac^Ⓡ). What’s more, the clinical benefit rate (CBR), disease control rate (DCR), duration of response (DoR) and progression-free survival (PFS) of the study will also be released at the 12^thEuropean Breast Cancer Conference (EBCC), and the abstract will be released on 18^thSeptember, the E-poster will be released on 2^nd October.

Details of HLX02 study at ESMO are as follows:

汉曲优^Ⓡ (trastuzumab biosimilar, EU brand name: Zercepac^Ⓡ) is developed by Henlius independently. The development process strictly followed the National Medical Products Administration (NMPA) and European Medicines Agency (EMA) biosimilar guidelines, and 汉曲优^Ⓡ has been approved by the NMPA and the European Commission (EC) recently, making it the first China-developed monoclonal antibody (mAb) biosimilar to be approved both in China and in the EU. The HLX02 Phase 3 study (HLX02-BC01, NCT03084237 and EudraCT: 2016-000206-10) is a multi-centre, randomised, double-blind, parallel-controlled trial in patients with recurrent or metastatic HER2-positive breast cancer who had not received prior systemic treatment to demonstrate equivalence in the efficacy, safety and pharmacokinetics between HLX02 and European Union (EU)-sourced trastuzumab (TZB). Professor Binghe Xu, Cancer Hospital Chinese Academy of Medical Sciences is the principle investigator of this study. Henlius has presented a part of sub-group analysis results of this HLX02 Phase 3 clinical trial at CSCO in 2019 and the Week 24 efficacy and safety results from different analysis sets at ESMO and ESMO Asia in 2019. Here, we reported the updated 1-year efficacy and safety results of the Phase 3 study and the PopPK model.

In the multi-centre, randomised, double-blind, parallel-controlled HLX02-BC01 Phase 3 study (NCT03084237, EudraCT: 2016-000206-10), patients with HER2-positive recurrent or metastatic breast cancer who had not received prior systemic treatment were randomised (1:1) to receive either HLX02 or European Union (EU) - sourced trastuzumab (TZB) in combination with docetaxel in a 3-week cycle for up to 1 year. The primary endpoint was overall response rate after 8 treatment cycles at Week 24 (ORR_wk24). The PopPK model was developed with the data from the HLX02-BC01 and HLX02-HV01 (NCT02581748) studies (HLX02, N=356; TZBs, N=398; Serum sample, N=5882) using non-linear mixed-effect modelling (NONMEM^Ⓡ) with the first-order estimation with interaction (FOCEI) method. Important covariates (e.g. demographics, pathophysiologic and disease conditions) were included in model characterisation for the evaluation of pharmacokinetic-pharmacodynamic (PK-PD) correlation. A total of 1,000 simulations were tested using the observed covariates.

The results of the Phase 3 study and the PopPK model demonstrated the equivalent efficacy and similar safety and PK between HLX02 and reference TZB in patients with HER2-positive metastatic breast cancer. HLX02, as the first approved China (CN) - manufactured TZB biosimilar, will be able to provide alternative treatment option for patients globally.

Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology and autoimmune diseases. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialisation. It has three R&D facilities in Shanghai, Taipei and California and a Shanghai-based manufacturing facility certificated by China and the European Union (EU) Good Manufacturing Practice (GMP).

Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monocolonal antibodies (mAb) and has continued to explore immuno-oncology combination therapies with proprietary HLX10 (anti-PD-1 mAb) as backbone. After 汉利康^Ⓡ(HLX01, rituximab) was launched commercially, 汉曲优^Ⓡ (HLX02, trastuzumab, EU brand name: Zercepac^Ⓡ) also has been approved in the EU and China, becoming the first China-developed mAb biosimilar approved both in the EU and China. Up to date, in addition to 2 products launched successfully and 1 product (HLX03 adalimumab) to be potentially launched within 2020, Henlius has conducted over 20 clinical studies for 10 products and 8 combination therapies worldwide. Products have been licensed out to nearly 100 countries and regions.