Open Access
Tableau IV.
Résultats des principales études cliniques des candidats biosimilaires du trastuzumab. IC: intervalle de confiance ; ORR: objective response rate ; pCR: pathological complete response ; PK: pharmacocinétique.
| ABP980 [17] | Bioepis/Merck SB3 [19] | CT-P6 [18] | PF-05280014 [20, 27] | MYL-1401O [26] | |
|---|---|---|---|---|---|
| Néo-adjuvant | ✔ | ✔ | ✔ | ✔ | |
| N | 725 | 875 | 549 | 226 | |
| Métastastique | - | - | ü | ü | ü |
| N | - | - | 475 | 707 | 458 |
| Objectif principal | Total pCR | Sein pCR | Néo-adj: total pCRMéta: ORR | Néo-adj: PK Méta: ORR | ORR |
| Bornes Equivalences (différence absolue) | 90 % IC ±13 % | 95 % IC ±13 % | Néo-adj: 95% IC ±15 % Méta: 95% IC ±15 % | Néo-adj: 95% IC 0,8–1,25 (risk ratio) | 95 % IC ± 15% |
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