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) |
| 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.