Dr. Esteva on Trastuzumab Biosimilar in Patients With HER2+ Breast Cancer

Francisco J. Esteva, MD, PhD, medical oncology, New York Langone Medical Center, discusses a randomized phase III study of the biosimilar version of trastuzumab (Herceptin) in patients with HER2-positive metastatic breast cancer.

Researchers compared the efficacy and safety of the biosimilar version of trastuzumab, MYL-1401O, plus a taxane with trastuzumab plus a taxane in approximately 500 patients. Results showed that the biosimilar and trastuzumab were similar in both aspects.

In the study, MYL-1401O demonstrated an overall response rate (ORR) of 69.6% among women who received the biosimilar in combination with a taxane compared with a 64% ORR for patients who received trastuzumab plus a taxane. Serious adverse events occurred in 38% of patients in the biosimilar arm compared with 36% in the trastuzumab arm.