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Samsung Bioepis Presents 5-Year Follow-up Results on Trastuzumab Biosimilar at ESMO 2021
Samsung Bioepis has announced results of its five-year follow-up study showing that their breast cancer treatment Ontruzant (trastuzumab biosimilar) is just as effective and safe as Herceptin (trastuzumab), originally developed by Roche’s Genentech.
Ontruzant Versus Trastuzumab
The Phase 3 study compared Ontruzant and reference trastuzumab in patients with early or locally advanced HER2 positive breast cancer.
The study showed that Ontruzant was comparable to trastuzumab in terms of cardiac safety and efficacy. Of the 875 patients randomized in the study, 367 patients were enrolled in the follow-up, with 186 receiving Ontruzant and 181 receiving trastuzumab.
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During the treatment-free follow-up period, a decrease in asymptomatic significant left ventricular ejection fraction (LVEF), an indicator of heart failure, rarely occurred for both groups. There were no reported cases of symptomatic congestive heart failure or cardiac arrest in either group.
Five-year event-free survival rates were 82.8% in the biosimilar trastuzumab group and 79.7% in the reference medicine group. An event is defined as cancer recurrence, progression, or death. The five-year overall survival rates were 93.1% in the Ontruzant group and 86.7% in the trastuzumab group.
According to Donghoon Shin, Vice President and Medical and Lifecycle Safety Team Leader at Samsung Bioepis, the five-year follow-up results are the longest monitoring data of patients treated with a trastuzumab biosimilar for HER2-positive early or locally advanced breast cancer.
He said the company looks forward to sharing its data with the oncology community on the usage of biosimilars based on the long-term follow-up data. The company will present the findings at the European Society of Medical Oncology (ESMO) Virtual Congress 2021. Sales of Ontruzant in Europe and the US increased 13% to $45 million in the first half of 2021.
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