Samsung Bioepis Presents Five-year Follow-up Results of Ontruzant (biosimilar- trastuzumab) in Early or Locally Advanced HER2 Positive Breast Cancer at ESMO 2021
- The P-III study evaluates the cardiac safety profiles & efficacy of Ontruzant vs reference trastuzumab in 367 patients with HER2 positive early or LA BC for 4yrs. after randomization
- Patients were randomized to receive 8 cycles of either Ontruzant or TRZ with concurrent neoadjuvant CT. After surgery- patients received 10 cycles of biosimilar trastuzumab or TRZ completing 1yrs. of treatment
- In follow up study- the reduction in asymptomatic LVEF at both groups- 3 patients recovering with LVEF ≥ 50%- no cases of heart failure or cardiac death observed- EFS rates (82.8% vs 79.7%)- OS rates (93.1% vs 86.7%)- number of events i.e. recurrence- progression- or death (17.2% vs 21%)
| Ref: Globe Newswire | Image: Samsung Bioepis
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