Samsung Bioepis Announces 4-Year Follow-Up Clinical Results of 'Ontruzant'

[Asia Economy Reporter Cho Hyun-ui] Samsung Bioepis announced on the 29th (local time) that it revealed new follow-up clinical results of the anticancer drug 'Ontruzant' at the poster session of the American Society of Clinical Oncology (ASCO) conference. Ontruzant is a biosimilar of 'Herceptin,' developed by Genentech and marketed by the multinational pharmaceutical company Roche.

Samsung Bioepis is conducting a comparative study on the efficacy and safety of Ontruzant and the original drug in 367 patients who agreed to follow-up observation after the initial clinical trial. The total follow-up period is five years, and the data announced this time covers the first four years, corresponding to 53 months.

According to the study results, the number of patients with decreased left ventricular ejection fraction (LVEF), an indicator of abnormal heart function, was one in the Ontruzant group and two 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.

Regarding drug efficacy, the event-free survival rate (EFS), which is the proportion of patients surviving without serious side effects, recurrence, or metastasis after treatment initiation, was 83.4% in the Ontruzant group and 80.7% in the original drug group.

The overall survival rate (OS), indicating the proportion of patients surviving after a certain period post-treatment, was 94.4% in the Ontruzant group and 89.6% in the original drug group.

Samsung Bioepis presented a total of three clinical medical research results related to Ontruzant at this conference, including the four-year follow-up clinical results.

Kim Hee-kyung, Executive Director (Head of Clinical Medicine Division) at Samsung Bioepis, said, "We hope that more patients can benefit from biopharmaceuticals through biosimilar development," adding, "We expect our research results to have a positive impact on expanding prescriptions of Ontruzant, which was recently launched in the U.S. market."

Meanwhile, Samsung Bioepis officially entered the anticancer drug market in the world's largest pharmaceutical market by launching Ontruzant in the U.S. last April. Samsung Bioepis plans to strengthen cooperation with its U.S. partner Merck (MSD) and leverage its supply and quality management capabilities to pave the way for market entry.

This content was produced with the assistance of AI translation services.