Dr. Esteva on the Trastuzumab Biosimilar Candidate CT-P6 in HER2+ Breast Cancer

Francisco J. Esteva, MD, PhD
Published: Tuesday, Dec 11, 2018



Francisco J. Esteva, MD, PhD, medical oncologist, New York University’s Perlmutter Cancer Center, discusses the efficacy and safety of the trastuzumab (Herceptin) biosimilar candidate CT-P6 in HER2-positive breast cancer.

At the 2018 San Antonio Breast Cancer Symposium, Esteva presented the 24-month results from a double-blind, randomized phase III trial comparing the efficacy and safety of neoadjuvant and adjuvant trastuzumab and its biosimilar candidate CT-P6 in patients with HER2-positive early breast cancer. In the study, 549 patients were randomized to anthracycline- and taxane-based chemotherapy in combination with trastuzumab versus chemotherapy in combination with CT-P6.

The primary endpoint of the study was pathologic complete response. Results were published in Lancet and showed similarity by the predefined criteria, says Esteva. Following surgery, patients continued on the treatment until completing 1 year of therapy. No difference in disease-free survival, overall survival, safety, or left ventricular ejection fraction was reported. Though CT-P6 has yet to be FDA approved, it adds to the totality of evidence for review, states Esteva.
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Francisco J. Esteva, MD, PhD, medical oncologist, New York University’s Perlmutter Cancer Center, discusses the efficacy and safety of the trastuzumab (Herceptin) biosimilar candidate CT-P6 in HER2-positive breast cancer.

At the 2018 San Antonio Breast Cancer Symposium, Esteva presented the 24-month results from a double-blind, randomized phase III trial comparing the efficacy and safety of neoadjuvant and adjuvant trastuzumab and its biosimilar candidate CT-P6 in patients with HER2-positive early breast cancer. In the study, 549 patients were randomized to anthracycline- and taxane-based chemotherapy in combination with trastuzumab versus chemotherapy in combination with CT-P6.

The primary endpoint of the study was pathologic complete response. Results were published in Lancet and showed similarity by the predefined criteria, says Esteva. Following surgery, patients continued on the treatment until completing 1 year of therapy. No difference in disease-free survival, overall survival, safety, or left ventricular ejection fraction was reported. Though CT-P6 has yet to be FDA approved, it adds to the totality of evidence for review, states Esteva.



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