Samsung Bioepis Reports P-III Trial Results of SB3 (biosimilar, trastuzumab) for HER2-Positive Breast Cancer
- The secondary analysis results from the P-III equivalence trial evaluating SB3 vs Herceptin in patients with HER2+ breast cancer showed no significant differences in event-free or overall survival b/w biosimilar and the reference product
- The results demonstrated an equivalent efficacy of SB3 to reference trastuzumab based on the risk ratio of bpCR rates, overall cardiac safety profile of SB3 was comparable to reference trastuzumab with the median follow-up duration was 68mos.
- Median LVEF at baseline was 65% vs 65% with a reduction in LVEF (0.4% vs 0.7%), no incidences of symptomatic congestive heart failure were seen, EFS (20% vs 25%), 5yr. EFS & OS rates (80% vs 75%) and (93% vs 85%)
Ref: Center For Biosimilar | Image: Samsung Bioepis
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