Samsung Bioepis Confirms Long-Term Efficacy and Safety of Anticancer Drug 'Ontruzant'

Samsung Bioepis New Headquarters Exterior (Photo by Samsung Bioepis)

[Asia Economy Reporter Chunhee Lee] Samsung Bioepis's biosimilar anticancer drug 'Ontruzant' has confirmed safety and efficacy similar to the original drug through a 5-year follow-up clinical trial.

Samsung Bioepis announced on the 13th that it disclosed the 5-year follow-up clinical results of Ontruzant (Herceptin biosimilar, generic name 'trastuzumab') at the European Society for Medical Oncology (ESMO) regular academic conference 'ESMO 2021 Virtual Congress,' held remotely.

Samsung Bioepis conducted an observational study on cardiac function safety and long-term efficacy over 5 years with a total of 367 HER2-positive early breast cancer patients or locally advanced breast cancer patients who agreed to follow-up observation. The study results correspond to clinical data collected over approximately 68 months.

As a result, the number of patients with significantly decreased asymptomatic left ventricular ejection fraction (LVEF), an indicator of abnormal cardiac function, was 1 in the Ontruzant group and 2 in the original drug group, both showing low values. Another safety indicator, signs related to congestive heart failure (CHF), were not found in either group.

In terms of efficacy, the 5-year event-free survival (EFS), which indicates survival without recurrence, progression, or death after treatment initiation, was 82.8% in the Ontruzant group and 79.7% in the original drug group. The 5-year overall survival (OS rate), the proportion of patients surviving after a certain period post-treatment, was 93.1% for Ontruzant and 86.7% for the original drug, confirming that the survival duration of the Ontruzant group was similar to that of the original drug group.

Through this, Samsung Bioepis evaluated that the cardiac function safety and long-term efficacy of Ontruzant and the original drug are similar.

Donghoon Shin, Executive Director (Head of Medical Team) at Samsung Bioepis, said, "This announcement is the result of the longest monitoring period of trastuzumab biosimilars in HER2-positive early breast cancer or locally advanced breast cancer patients," adding, "We expect it to have a positive impact on expanding treatment opportunities for patients through our high-quality biopharmaceuticals in the future."