Table 1 Results of the randomised clinical studies achieved by major trastuzumab biosimilar candidates.1,2,3,4,5,8
From: Can we establish a hierarchy among trastuzumab biosimilar candidates?
Amgen ABP9805 | Samsung BioEpis/Merck SB32 | Celltrion CT-P64a | Biocon/Mylan MYL-1401O3 | ||
|---|---|---|---|---|---|
Neoadjuvant setting | ✓ | ✓ | ✓ | ✓ | |
N | 725 | 875 | 549 | 226 | |
Metastastic setting | — | — | ✓ | ✓ | ✓ |
N | 475 | 707 | 458 | ||
Primary endpoint | Total pCR | Breast pCR | EBC: total pCR MBC: ORR | EBC: PK (Ctrough > 20 μg/ml at Cycle 5 [Cycle 6 predose]) MBC: ORR | ORR |
Equivalence margins for efficacy (risk difference) | 90% CI ± 13% | 95% CI ± 13% | EBC: 95% CI ± 15% MBC: 95% CI ± 15% | MBC: 95% CI 0.8–1.25 (risk ratio) | 95% CI ± 15% |
Primary endpoint (Biosimilar vs Herceptin) | 48% vs 40.5% | 51.7% vs 42% | EBC 46.8% vs 50.4% | MBC 62.5% vs 66.5% | 69.6% vs 64% |
Results observed (risk difference) | 7.3% (1.2%,13.4%) | 10.7% (4.1%, 17.3%) | EBC: −4% (12%, 5%) | MBC (risk ratio): 0.94 (0.84–1.05) | 5.53% (−3.08, 14.04%) |
