Samsung Bioepis Announces Results of Phase 3 Breast Cancer Treatment

The results of a 5-year follow-up study comparing trastuzumab (Ontruzant) and reference medicine trastuzumab show comparable cardiac safety profiles and long-term efficacy.

The results of a 5-year follow-up study comparing trastuzumab (ONTRUZANT) and reference medicine trastuzumab show long-term efficacy in early or locally advanced HER2-positive breast cancer.

“The 5-year follow-up results presented at this year’s [European Society for Medical Oncology (ESMO) meeting] is the longest monitoring data of patients treated with a trastuzumab biosimilar for HER2-positive early or locally advanced breast cancer,” Donghoon Shin, Samsung Bioepis’s vice president and medical and lifecycle safety team leader, said in a statement.

“This valuable data signifies our continuous dedication in producing high-quality treatments with proven efficacy and safety. We remain committed to patients we serve through our rigorous research and development to ensure quality treatment,” Shin said.

“We look forward to sharing our data with the oncology community on the usage of biosimilars based on this long-term follow-up data,” he said.

Individuals received 8 cycles of either Ontruzant or the reference medicine along with chemotherapy in a neoadjuvant setting.

After surgery, the individuals received 10 cycles of either medication for a 1-year treatment. Three hundred and sixty-seven individuals were part of the follow-up study, with the median duration being 68 months.

The 5-year event free survival rate was 82.8% for the Ontruzant group and 79.7% for the reference medicine group. The overall survival rate was 93.1% and 86.7%, respectively.

The findings of the phase 3 study will be presented at the ESMO.

Reference

Samsung Bioepis announces five-year follow-up results for ONTRUZANT (trastuzumab) in early or locally advanced HER2 positive breast cancer at the European Society for Medical Oncology (ESMO) Virtual Congress 2021. Samsung Bioepis. News release. September 13, 2021. Accessed September 10, 2021. https://www.globenewswire.com/news-release/2021/09/12/2295419/0/en/Samsung-Bioepis-Announces-Five-year-Follow-up-Results-for-ONTRUZANT-trastuzumab-in-Early-or-Locally-Advanced-HER2-Positive-Breast-Cancer-at-the-European-Society-for-Medical-Oncolog.html