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.
The primary endpoint of the study was pCR at the time of definitive surgery. We are now assessing the DFS and the OS rates, which are secondary endpoints on the study. We hope the totality of the data generated by this trial will be sufficient to get it approved by the FDA.
Can you touch on the development and testing of a biosimilar?
When we started this project, no biosimilars were approved by the FDA [for the treatment of cancer]. Now, there are several monoclonal antibody biosimilars approved, and there will be more in the next few years. The standard drug development for originator antibodies such as [trastuzumab] involves phase I, II, and III trials. But, for biosimilars, that is not required by the FDA. Once similarity is demonstrated, the agency will likely allow extrapolation to other indications related to the reference drug.
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