Francisco J. Esteva, MD, PhD
Although MYL-1401O (Ogivri; trastuzumab-dkst) is the sole trastuzumab (Herceptin) biosimilar currently approved in the United States, there are multiple biosimilars for this biologic in the pipeline, said Francisco J. Esteva, MD, PhD.
Esteva, director of breast medical oncology at NYU Langone’s Perlmutter Cancer Center, discussed the journey of CT-P6 and its promise as a potential biosimilar for trastuzumab in the United States.
OncLive: Could you provide some background information on this phase III equivalence trial of CT-P6?
We conducted a randomized, phase III, multicenter trial to compare the reference trastuzumab with the biosimilar candidate CT-P6. We decided to study it in patients with early-stage breast cancer in the neoadjuvant setting with standard chemotherapy with the primary endpoint of pCR as opposed to overall survival (OS) or disease-free survival (DFS), which takes much longer.
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