Francisco J. Esteva, MD, PhD
CT-P6, a proposed biosimilar to trastuzumab, exhibited long-term disease-free survival (DFS) and overall survival (OS) similar to the reference product in the treatment of patients with HER2-positive early breast cancer. Two-year results from a phase III comparison confirmed the similar efficacy and safety that was apparent at 1 year.
In addition, breast pCR was similar between CT-P6 and reference trastuzumab (51.6% vs 55.1%, respectively) and for pCR without ductal carcinoma in situ (39.9% vs 41.4%).
- Esteva FJ, Lee S, Yu S, et al. 24 months results from a double-blind, randomized phase III trial comparing the efficacy and safety of neoadjuvant then adjuvant trastuzumab and its biosimilar candidate CT-P6 in HER2 positive early breast cancer (EBC). Presented at: 2018 San Antonio Breast Cancer Symposium; December 5-8; San Antonio, Tx. Abstract P6-17-03.
- Stebbing J, Baranau Y, Baryash V, et al. CT-P6 compared with reference trastuzumab for HER2-positive breast cancer: a randomised, double-blind, active-controlled, phase 3 equivalence trial. Lancet Oncology. 2017;18:917-928.
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