Biosimilar for HER2+ breast cancer achieves similar overall response rate to reference drug

In Clinical Studies News by Barbara Jacoby

Source: European Society for Medical Oncology


The trastuzumab biosimilar HLX02 achieved similar overall response rate to reference trastuzumab in women with human epidermal growth factor receptor 2-positive (HER2+) recurrent or previously untreated metastatic breast cancer, according to a large, randomised phase III study reported at the ESMO Asia 2019 Congress.

The anti-HER2 antibody trastuzumab given in combination with chemotherapy has significantly improved overall survival in patients with HER2-positive breast cancer and become the standard of care over the past decade. However, the cost can limit patient access to this treatment in regions with limited financial resources for healthcare.

The development of biosimilars, which are medicinal products containing a similar version of the active substance of their biological originator or reference product and are derived from living organisms, offers a way of improving access to cancer treatments by increasing treatment options and reducing cost.

The new study randomised women with HER2-positive breast cancer to HLX02, a fully humanised anti-HER2 that was developed in China as a trastuzumab biosimilar, or to reference trastuzumab sourced from the European Union.

“Overall response rate at week 24 was similar for HLX02 and reference trastuzumab with no statistical difference observed between the two treatment groups,” reported Xu. The rates of adverse events and treatment emergent adverse events were similar for HLX02 and reference trastuzumab and there were no differences in safety profiles or immunogenicity.

“HLX02 is equally safe and effective as the reference trastuzumab and has been rigorously evaluated by regulatory authorities such as the European Medicines Agency (EMA), based on sound scientific principles,” said Xu. He added, “HLX02 has a clear potential to drive down spending on HER2+ cancer treatment,” although he said the price has not yet been agreed.