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

 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

Shots:

  • 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

Click here ­to­ read full press release/ article | Ref: PRNewswire  | Image: Samsung Bioepis

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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