Biological medicine developer Celltrion Healthcare reported positive results from its phase 3 trial of CT-P6, a biosimilar of Roche Holding Ltd.'s Herceptin, in patients with early breast cancer and overexpression of HER2, a breast cancer development gene.
The pathological complete response rate at surgery, the primary endpoint, was 46.8% for CT-P6 and 50.4% for the reference blockbuster in the pre-protocol set.
Secondary endpoints were overall response rate, pharmacokinetics, pharmacodynamics and safety. CT-P6 and the reference product were similar in all secondary efficacy endpoints.
CT-P6 has been submitted to the European Medicines Agency for approval in all indications of the reference product. The biosimilar candidate is the second oncological biosimilar for Celltrion.