Table 3.
Time to next therapy by MRD status and durability
| TTSAT by MRD status | MAIA | ALCYONE | ||
|---|---|---|---|---|
| D-Rd (n = 368; ITT) | Rd (n = 369; ITT) | D-VMP (n = 350; ITT) | VMP (n = 356; ITT) | |
| MRD negative (10‒5) at ≥1 time point, n (%) * | 106 (28.8%) | 34 (9.2%) | 94 (26.9%) | 25 (7.0%) |
| Number of events (%); number censored (%)† | 5 (4.7%); 101 (95.3%) | 2 (5.9%); 32 (94.1%) | 13 (13.8%); 81 (86.2%) | 9 (36.0%); 16 (64.0%) |
| Median (95% CI), mo | NR (42.5-NE) | NR (NE-NE) | NR (46.4-NE) | 44.4 (36.5-NE) |
| HR (95% CI), P value | 0.54 (0.10-2.95); P = .4661‡ | 0.38 (0.16-0.88); P = .0197‡ | ||
| 36-mo TTSAT rate, % (95% CI) | 96.9 (90.6-99.0) | 90.5 (64.4-97.8) | 88.7 (80.1-93.8) | 75.3 (53.0-88.1) |
| MRD positive, n (%) * | 262 (71.2%) | 335 (90.8%) | 256 (73.1%) | 331 (93.0%) |
| Number of events (%); number censored (%)† | 82 (31.3%); 180 (68.7%) | 152 (45.4%); 183 (54.6%) | 110 (43.0%); 146 (57.0%) | 203 (61.3%); 128 (38.7%) |
| Median (95% CI), mo | NR (NE-NE) | 34.8 (29.2-NE) | 43.8 (35.3-NE) | 24.9 (21.9-27.3) |
| HR (95% CI), P value | 0.58 (0.44-0.75); P<.0001‡ | 0.53 (0.42-0.68); P<.0001‡ | ||
| 36-mo TTSAT rate, % (95% CI) | 65.4 (58.7-71.2) | 48.7 (42.6-54.5) | 54.9 (48.1-61.2) | 33.2 (27.7-38.8) |
| Achieved and remained MRD negative (10‒5) for ≥ 6 mo, n (%) * | 55 (14.9%) | 16 (4.3%) | 55 (15.7%) | 16 (4.5%) |
| Number of events (%); number censored (%)† | 2 (3.6%); 53 (96.4%) | 0 (0%); 16 (100.0%) | 5 (9.1%); 50 (90.9%) | 3 (18.8%); 13 (81.3%) |
| Median (95% CI), mo | NR (NE-NE) | NR (NE-NE) | NR (46.4-NE) | NR (44.4-NE) |
| HR (95% CI), P value | NR (0-NE); P = .4674‡ | 0.53 (0.13-2.22); P = .3746‡ | ||
| 36-mo TTSAT rate, % (95% CI) | 96.1 (85.2-99.0) | 100.0 (100.0-100.0) | 96.3 (85.9-99.1) | 93.8 (63.2-99.1) |
| MRD negativity (10−5) not lasting ≥6 mo, n (%) * | 51 (13.9%) | 18 (4.9%) | 39 (11.1%) | 9 (2.5%) |
| Number of events (%); number censored (%)† | 3 (5.9%); 48 (94.1%) | 2 (11.1%); 16 (88.9%) | 8 (20.5%); 31 (79.5%) | 6 (66.7%); 3 (33.3%) |
| Median (95% CI), mo | NR (42.48-NE) | NR (34.66-NE) | NR (NE-NE) | 32.6 (14.1-NE) |
| HR (95% CI), P value | 0.30 (0.4-2.17); P = .2069‡ | 0.28 (0.10-0.80); P = .0113‡ | ||
| 36-mo TTSAT rate, % (95% CI) | 98.0 (86.6-99.7) | 78.7 (31.8-95.1) | 77.2 (59.3-87.9) | 38.9 (9.3-68.7) |
| Achieved and remained MRD negative (10−5) for ≥12 mo, n (%) * | 40 (10.9%) | 9 (2.4%) | 49 (14.0%) | 10 (2.8%) |
| Number of events (%); number censored (%)† | 2 (5.0%); 38 (95.0%) | 0 (0%); 9 (100.0%) | 4 (8.2%); 45 (91.8%) | 1 (10.0%); 9 (90.0%) |
| Median (95% CI), mo | NR (NE-NE) | NR (NE-NE) | NR (46.4-NE) | NR (44.4-NE) |
| HR (95% CI), P value | NR (0-NE); P = .4975‡ | 0.99 (0.11-8.86); P = .9897‡ | ||
| 36-mo TTSAT rate, % (95% CI) | 94.6 (80.1-98.6) | 100.0 (100.0-100.0) | 95.8 (84.2-98.9) | 100.0 (100.0-100.0) |
| MRD negativity (10−5) not lasting ≥12 mo, n (%) * | 66 (17.9%) | 25 (6.8%) | 45 (12.9%) | 15 (4.2%) |
| Number of events (%); number censored (%)† | 3 (4.5%); 63 (95.5%) | 2 (8.0%); 23 (92.0%) | 9 (20.0%); 36 (80.0%) | 8 (53.3%); 7 (46.7%) |
| Median (95% CI), mo | NR (42.48-NE) | NR (34.66-NE) | NR (44.2-NE) | 37.0 (27.6-NE) |
| HR (95% CI), P value | 0.30 (0.04-2.17); P = .2082‡ | 0.36 (0.14-0.95); P = .0305‡ | ||
| 36-mo TTSAT rate, % (95% CI) | 98.5 (89.6-99.8) | 85.2 (47.6-96.6) | 80.5 (64.7-89.8) | 57.8 (29.0-78.4) |
NE, not evaluable; NR, not reached.
*
Percentages calculated using the total number of patients in each column heading (ITT population) as the denominator.
†
Percentages calculated using the number of patients in each column from the row immediately above number of events (%); number censored (%).
‡
HR and 95% CI from a Cox proportional hazards model with treatment group as the sole explanatory variable. An HR < 1 indicates an advantage for D-Rd or D-VMP. P value is based on the log-rank test.