Samsung Bioepis Confirms Safety and Effectiveness of Biosimilar Trastuzumab for Breast Cancer

Samsung Bioepis said it has confirmed the long-term safety and efficacy profiles of Ontruzant (ingredient: trastuzumab), a biosimilar to anti-cancer drug trastuzumab, in a five-year follow-up study.

The company will present the results of its long-term study comparing Ontruzant) and the benchmark drug trastuzumab in early-stage or locally advanced human epidermal growth factor receptor 2 (HER2) positive breast cancer at the virtual congress organized by the European Society of Medical Oncology (ESMO).

“The five-year follow-up results are the longest surveillance data from patients treated with Ontruzant for early or locally advanced HER2-positive breast cancer,” said Shin Dong-hoon, vice president and chief executive officer. life cycle and medical safety team at Samsung Bioepis. “The study results reflect our continued commitment to produce high quality treatments with proven efficacy and safety, and our commitment to patients with research and development to ensure quality treatment. “

Shin added that the company was eager to share the data analyzed during the five-year follow-up of biosimilars with the oncology community.

In the study, the patients included received eight cycles of Ontruzant or trastuzumab with neoadjuvant therapy. After surgery, patients received 10 cycles of Ontruzant or the reference drug, completing one year of treatment.

The company enrolled 367 patients in the follow-up study – 186 in the Ontruzant group and 181 in the reference drug group – with a median follow-up time of 68 months.

Ostrzant and trastuzumab did not cause symptomatic congestive heart failure or cardiac death reported in either group. However, the company explained that the number of recurrences, progression or death was reported in 32 patients, or 17.2% of participants, in the Ontruzant group and 38 patients in the reference drug group.

The five-year event-free survival rate of patients was 82.8% in the Ontruzant group and 79.7% in the trastuzumab group. Patients treated with Ontruzant achieved 93.1% overall five-year survival rates. Those who received the reference drug scored 86.7%, showing a similar therapeutic effect to that of the original drug.

The results of the five-year follow-up of Ontruzant’s Phase 3 study will be presented in poster form at ESMO 2021 on Thursday.