Samsung Bioepis Reports Results of Ontruzant (biosimilar, trastuzumab) in P-III Follow-up Study (SB3-G31-BC-E) for Early or Locally Advanced HER2-Positive Breast Cancer


  • The four-year follow-up data is part of the ongoing follow-up study, assessing the cardiac safety and survival outcome of Ontruzant vs Herceptin in a subgroup of patients from P-III study with completed neoadjuvant and adjuvant therapy for 1yr. 367 out of 875 patients were enrolled in the extension study, with a median follow-up of 53mos.
  • Four-year follow-up data: EFS (83.4% vs 80.7%); OS (94.4% vs 89.6%); no occurrence of symptomatic CHF with a very low incidence of asymptomatic significant LVEF decrease. The data supports comparable safety and efficacy profiles of Ontruzant to the Herceptin
  • Ontruzant showed high bio-similarity to Herceptin in terms of safety, purity and potency of therapy and has received the FDA’s approval in Jan’2019. The company will present the four year follow-up data in ASCO

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Related News: Samsung Bioepis Receives the US FDA’s Approval for Multi-Dose Vial of Ontruzant (biosimilar, trastuzumab)