MedicalResearch.com Interview with:
Prof Francisco J Esteva MD PhD
Director of the breast medical oncology program at Perlmutter Cancer Center.
NYU Langone Medical Center
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Trastuzumab is a monoclonal antibody directed against the human epidermal growth factor receptor 2 (HER-2). Trastuzumab therapy has been shown to improve survival in patients with early-stage and metastatic her-2 positive breast cancer.
In this study, we compared the safety and efficacy of the trastuzumab originator (Herceptin) to a trastuzumab biosimilar (CT-P6) in patients with stage I-III HER-2 positive breast cancer receiving neoadjuvant chemotherapy. The study was a randomized phase III trial.
We found the pathological complete response rates were similar in both groups. Both antibodies were safe. Pharmacokinetic studies showed similar plasma concentrations for the trastuzumab originator and the proposed biosimilar.
MedicalResearch.com: What should readers take away from your report?
Response: Our study showed CT-P6 is as safe and effective as the reference trastuzumab antibody in a randomized trial, in patients with early-stage breast cancer. If approved by regulators, the availability of monoclonal antibody biosimilars is expected to reduce cost and improve access to this therapy globally.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Regulatory agencies in the US and Europe are evaluating therapeutic monoclonal antibodies for cancer treatment. To date, no therapeutic biosimilars have been approved for cancer patients. Our study is one of the first randomized trials showing biosimilarity for CT-P6 in patients with Her-2 positive early-stage breast cancer. Future studies will evaluate novel combinations using trastuzumab biosimilars.
Disclosures: Our study was funded by Celltrion. I have served as a consultant for Celltrion, Pfizer, Genentech and Novartis.
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Citation: ASCO poster June 2017
Double-blind, randomized phase III study to compare the efficacy and safety of CT-P6, trastuzumab biosimilar candidate versus trastuzumab as neoadjuvant treatment in HER2 positive early breast cancer (EBC).
Author(s): Justin Stebbing, Yauheni Valerievich Baranau, Valery Baryash, Alexey Manikhas, Vladimir Moiseyenko, Giorgi Dzagnidze, Edvard Javrid, Dmytro Boliukh, Daniil Stroyakovskiy, Joanna Pikiel, Alexandru E. Eniu, Dmitry Komov, Zakaria Zautashvili, Gabriela Morar-Bolba, Rubi Khaw Li, Igor Lifirenko, Andriy V. Rusyn, Sang Joon Lee, Sung Young Lee, Francisco J. Esteva; Imperial College Healthcare NHS Trust, London, United Kingdom; Minsk City Clinical Oncology Dispensary, Minsk, Belarus; City Clinical Oncology Dispensary, St. Petersburg, Russian Federation; St Petersburg Clinical Center of Specialized Medical Care, St. Petersburg, Russia; National Cancer Centre, Tbilisi, Georgia; N.N. Alexandrov Republican Scientific and Practical Centre of Oncology and Medical Radiology, Minsk, Belarus; Vinnytsya Regional Clinical Oncology Dispensary, Vinnytsya, Ukraine; Moscow City Oncology, Moscow, Russia; Wojewódzkie Centrum Onkologii, Gdansk, Poland; Cancer Institute Prof. Dr. Ion Chiricuta, Cluj-Napoca, Romania; Russian Oncology Research Centre Blokhin N.N., Moscow, Russia; Research Institute of Clinical Medicine, Tbilisi, Georgia; Cancer Institute, Cluj-Napoca, Romania; St Luke’s Medical Center, Quezon City, Philippines; Kursk Regional Oncologic Dispensary, Kursk, Russia; Transkarpathian Regional University, Uzhgorod, Ukraine; CELLTRION, Inc., Incheon, Republic of Korea; New York University Cancer Institute, New York, NY
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