Table 2:
Overall Survival and Relapse-free Survival Results
Study | Treatment Groups | Consolidation Arms | OS HR (95% CI) | RFS HR (95% CI) |
---|---|---|---|---|
E1910 | MRD− | Blin + chemo (n=112) vs chemo (n=112) | 0.42 (0.24, 0.75) p = 0.003* |
N/A |
MRD+ | Blin + chemo (n=40) vs chemo (n=22) | 0.40 (0.14, 1.13) | N/A | |
20120215 | High-risk | Blin (n=54) vs chemo (n=57) | 0.35 (0.17, 0.70) | 0.38 (0.22, 0.66) |
AALL1331 | High- or intermediate-risk | Blin (n=105) vs chemo (n=103) | 0.71 (0.47, 1.08) | N/A |
Low-risk | Blin + chemo (n=127) vs chemo (n=128) | 0.46 (0.24, 0.88) | N/A |
Source: FDA analysis
Abbreviations: OS: overall survival; RFS: relapse-free survival; MRD: minimal residual disease; Blin: blinatumomab; chemo: chemotherapy
Only comparison that met the prespecified criteria for statistical significance