Efficacy end points for expansion cohort/matched controls (modified ITT population)
| End point . | Rate, % (95% CI)∗ . | HR (95% CI)§ . | P . | |
|---|---|---|---|---|
| Matched controls (n = 92) . | CD24Fc 480/240/240 mg† (n = 26‡) . | |||
| Primary end point | ||||
| Grade 3-4 acute GFS through day 180 | 73.6 (63.2-81.4) | 96.2 (75.7-99.4) | 0.1 (0.0-0.6) | .03 |
| Secondary end points | ||||
| Grade 2-4 acute GFS through day 180 | 49.4 (38.8-59.2) | 64.4 (42.6-79.7) | 0.6 (0.3-1.1) | .30‖ |
| RFS through 1 y | 71.6 (61.2-79.7) | 64.8 (43.2-79.9) | 1.3 (0.7-2.5) | .91‖ |
| OS through 1 y | 79.2 (69.3-86.2) | 76.7 (55.3-88.8) | 1.1 (0.4-2.9) | .91‖ |
| Exploratory end points | ||||
| Grade 2-4 acute GVHD, cumulative incidence through day 100 | 47.8 (37.3-57.6) | 30.8 (14.3-49.0) | 0.5 (0.3-1.1) | — |
| Chronic GVHD, cumulative incidence through 1 y | 48.9 (38.1-58.8) | 50.0 (29.2-67.7) | 1.1 (0.6-2.0) | — |
| Relapse, cumulative incidence through 1 y | 17.5 (10.5-26.0) | 27.3 (11.8-45.5) | 1.6 (0.7-3.9) | — |
| Nonrelapse mortality, cumulative incidence through 1 y | 10.9 (5.5-18.3) | 7.7 (1.3-22.1) | 0.7 (0.2-3.1) | — |
| End point . | Rate, % (95% CI)∗ . | HR (95% CI)§ . | P . | |
|---|---|---|---|---|
| Matched controls (n = 92) . | CD24Fc 480/240/240 mg† (n = 26‡) . | |||
| Primary end point | ||||
| Grade 3-4 acute GFS through day 180 | 73.6 (63.2-81.4) | 96.2 (75.7-99.4) | 0.1 (0.0-0.6) | .03 |
| Secondary end points | ||||
| Grade 2-4 acute GFS through day 180 | 49.4 (38.8-59.2) | 64.4 (42.6-79.7) | 0.6 (0.3-1.1) | .30‖ |
| RFS through 1 y | 71.6 (61.2-79.7) | 64.8 (43.2-79.9) | 1.3 (0.7-2.5) | .91‖ |
| OS through 1 y | 79.2 (69.3-86.2) | 76.7 (55.3-88.8) | 1.1 (0.4-2.9) | .91‖ |
| Exploratory end points | ||||
| Grade 2-4 acute GVHD, cumulative incidence through day 100 | 47.8 (37.3-57.6) | 30.8 (14.3-49.0) | 0.5 (0.3-1.1) | — |
| Chronic GVHD, cumulative incidence through 1 y | 48.9 (38.1-58.8) | 50.0 (29.2-67.7) | 1.1 (0.6-2.0) | — |
| Relapse, cumulative incidence through 1 y | 17.5 (10.5-26.0) | 27.3 (11.8-45.5) | 1.6 (0.7-3.9) | — |
| Nonrelapse mortality, cumulative incidence through 1 y | 10.9 (5.5-18.3) | 7.7 (1.3-22.1) | 0.7 (0.2-3.1) | — |
Kaplan-Meier estimate.
Regimen (infusion): 480, 240, and 240 mg on days −1, 14, and 28, respectively.
Expansion cohort includes n = 6 participants from the double-blind, dose-escalation cohort and n = 20 additional participants from the open-label expansion phase.
For the expansion cohort, HRs were generated relative to matched controls.
Reports adjusted P value based on Hochberg procedure.