The confirmatory Phase 3 study results of Henlius HLX02 will be presented at the 22nd Congress of Chinese Society of Clinical Oncology (CSCO), Xiamen, China and the European Society for Medical Oncology (ESMO) Congress 2019, Barcelona, Spain.
As the first China-manufactured biosimilar conducted in a global, multicentre Phase 3 trial, HLX02 was developed in consultation with China National Medical Products Administration (NMPA) and the European Medicines Agency (EMA). Currently, HLX02 is the first trastuzumab biosimilar being accepted to review its new drug application (NDA) by the NMPA in accordance with the guideline for the development of biosimilars. In June 2019, the marketing authorisation application (MAA) of HLX02 were also accepted to review by EMA, becoming the first "Chinese" trastuzumab biosimilar being recognised by EMA. Following the step-wise clinical approach for the development of biosimilar, the results from the safety, tolerability and pharmacokinetic bioequivalence study (NCT02581748) between HLX02, China-sourced trastuzumab and European Union-sourced trastuzumab (EU-trastuzumab) (NCT02581748) were previously reported at CSCO-2018 oral presentation and ESMO-ASIA-2018 poster display.
Here, we conducted a multi-national, randomised, double-blind, parallel-controlled Phase 3 study (NCT03084237 and EudraCT: 2016-000206-10) to investigate the safety and efficacy equivalence of HLX02 and EU-trastuzumab in combination with docetaxel in HER2-positive recurrent or previously untreated metastatic breast cancer patients. The results have demonstrated equivalence in safety and efficacy between HLX02 and EU-trastuzumab in patients with HER2-positive recurrent or previously untreated metastatic breast cancer. Further study results will be reported once the follow-up and analysis are completed.
The exhibition details are as follows:
CSCO Congress 2019
Title: The Clinical Journey of First China-Manufactured Trastuzumab Biosimilar HLX02: From Phase 1 Clinical Trial to Global Phase 3 Trial in Metastatic Breast Cancer
Speaker: Binghe Xu, M.D. Ph.D.
Time: 15:30 – 15:36 pm, 20th Sept. 2019
Place: Breast Cancer Session 2, 2nd floor, Haixia Hall, Xiamen International Conference Center
ESMO Congress 2019
Title: Efficacy and Safety of First China-Manufactured Trastuzumab Biosimilar HLX02 for Metastatic Breast Cancer: A Phase 3 Trial
Speaker: Binghe Xu, M.D. Ph.D.
Time: 09:10 am, 29th Sept. 2019
Place: Cordoba Auditorium (Hall 7)
Poster ID / Location: 309PD / Full poster will be displayed at Hall 3
Henlius is a leading biopharmaceutical company in China that offers high-quality, affordable and innovative drugs to patients worldwide. Founded in 2010 and headquartered in Shanghai with two R&D centers in Taipei and California, Henlius has established and continues to expand its comprehensive product pipeline of biosimilars and bio-innovative drugs to treat tumors and autoimmune diseases.
Until now, in addition to one product launched commercially and two products under NDA/MAA review, Henlius has conducted over 20 clinical studies for 14 products and 6 combination therapies worldwide. HLX01, the first product of Henlius, has been granted approval by the NMPA as the first approved biosimilar in China. Moreover, HLX03 (adalimumab injection) and HLX02 have their NDA under primary review by the NMPA. HLX02 is the first biosimilar developed in China to enter a global multi-centre phase 3 clinical trial in China, Poland, Ukraine and the Philippines. In June 2019, the MAA for HLX02 was accepted to review by EMA.