Comparison of efficacy outcomes of CIBMTR with those of ELIANA and JULIET trials
| End point . | CIBMTR, % (95% CI) . | Pivotal trial, % (95% CI) . |
|---|---|---|
| CIBMTR vs ELIANA | (n = 249) | (n = 79) |
| BOR of CR | 85.5 (80.6-89.7) | 82.3 (72.1-90.0) |
| MRD− | 99.1 (n = 115/116) (95.3-100) | 100.0 (n = 64/64) (94.4-100) |
| DOR | ||
| At 6 mo | 78.1 (70.5-84.0) | 80.8 (68.0-88.9) |
| At 12 mo | 60.9 (49.4-70.5) | 67.4 (53.2-78.1) |
| EFS | ||
| At 6 mo | 68.6 (62.0-74.4) | 71.7 (59.8-80.6) |
| At 12 mo | 52.4 (43.4-60.7) | 57.2 (44.5-68.0) |
| OS | ||
| At 6 mo | 88.5 (83.6-92.0) | 88.6 (79.3-93.9) |
| At 12 mo | 77.2 (69.8-83.1) | 77.1 (66.1-84.9) |
| CIBMTR vs JULIET | (n = 152) | (n = 115) |
| ORR (CR + PR) | 61.8 (53.6-69.6) | 52.2 (42.7-61.6) |
| BOR of CR | 39.5 (31.6-47.7) | 38.3 (29.4-47.8) |
| DOR | ||
| At 6 mo | 55.3 (42.2-66.6) | 66.6 (52.8-77.3) |
| At 12 mo | 48.4* (33.9-61.5) | 62.7 (48.7-73.9) |
| PFS | ||
| At 6 mo | 38.7 (30.5-46.9) | 39.0 (29.7-48.2) |
| At 12 mo | 26.4* (17.2-36.6) | 34.7 (25.7-43.9) |
| OS | ||
| At 6 mo | 70.7 (62.2-77.6) | 61.2 (51.6-69.5) |
| At 12 mo | 56.3 (44.2-66.8) | 48.2 (38.6-57.1) |
| End point . | CIBMTR, % (95% CI) . | Pivotal trial, % (95% CI) . |
|---|---|---|
| CIBMTR vs ELIANA | (n = 249) | (n = 79) |
| BOR of CR | 85.5 (80.6-89.7) | 82.3 (72.1-90.0) |
| MRD− | 99.1 (n = 115/116) (95.3-100) | 100.0 (n = 64/64) (94.4-100) |
| DOR | ||
| At 6 mo | 78.1 (70.5-84.0) | 80.8 (68.0-88.9) |
| At 12 mo | 60.9 (49.4-70.5) | 67.4 (53.2-78.1) |
| EFS | ||
| At 6 mo | 68.6 (62.0-74.4) | 71.7 (59.8-80.6) |
| At 12 mo | 52.4 (43.4-60.7) | 57.2 (44.5-68.0) |
| OS | ||
| At 6 mo | 88.5 (83.6-92.0) | 88.6 (79.3-93.9) |
| At 12 mo | 77.2 (69.8-83.1) | 77.1 (66.1-84.9) |
| CIBMTR vs JULIET | (n = 152) | (n = 115) |
| ORR (CR + PR) | 61.8 (53.6-69.6) | 52.2 (42.7-61.6) |
| BOR of CR | 39.5 (31.6-47.7) | 38.3 (29.4-47.8) |
| DOR | ||
| At 6 mo | 55.3 (42.2-66.6) | 66.6 (52.8-77.3) |
| At 12 mo | 48.4* (33.9-61.5) | 62.7 (48.7-73.9) |
| PFS | ||
| At 6 mo | 38.7 (30.5-46.9) | 39.0 (29.7-48.2) |
| At 12 mo | 26.4* (17.2-36.6) | 34.7 (25.7-43.9) |
| OS | ||
| At 6 mo | 70.7 (62.2-77.6) | 61.2 (51.6-69.5) |
| At 12 mo | 56.3 (44.2-66.8) | 48.2 (38.6-57.1) |
Less than 10 patients at risk at this time point.