Baseline demographics and disease characteristics
| . | Arm A (azacitidine + durvalumab) (n = 42) . | Arm B (azacitidine monotherapy) (n = 42) . | ||||
|---|---|---|---|---|---|---|
| No. . | % . | Median (range) . | No. . | % . | Median (range) . | |
| Age, y | 73.0 (46-83) | 74.5 (57-89) | ||||
| Sex | ||||||
| Male | 28 | 30 | ||||
| Female | 14 | 12 | ||||
| ECOG status | ||||||
| 0 | 40.5 | 42.9 | ||||
| 1 | 47.6 | 47.6 | ||||
| 2 | 7.1 | 9.5 | ||||
| Hemoglobin, g/L | 91.5 (54-125) | 89.0 (38-129) | ||||
| Transfusion burden, units/28 d | 0.50 (0.0-7.0) | 2.00 (0.0-8.0) | ||||
| Platelet count × 109/L | 55.0 (5-347) | 46.5 (11-355) | ||||
| Low platelets (<100 000) | 0 | 0 | ||||
| ANC × 109/L | 0.990 (0.03-14.22) | 0.965 (0.10-7.99) | ||||
| Low ANC (<100) | ||||||
| Band form | 0 | 0 | ||||
| Segmented | 29 | 76 | 33 | 83 | ||
| Time since diagnosis, months | 2.1 (0.4-93.8) | 2.5 (0.0-42.1) | ||||
| MDS | ||||||
| Primary | 88.1 | 95.2 | ||||
| Secondary | 11.9 | 4.8 | ||||
| IPSS-R risk category (central)* | ||||||
| Intermediate | 2.4 | 7.1 | ||||
| High | 42.9 | 38.1 | ||||
| Very high | 47.6 | 50.0 | ||||
| IPSS-R cytogenetic risk category | ||||||
| Good/very good | 26.2 | 26.2 | ||||
| Intermediate | 21.4 | 19.0 | ||||
| Poor/very poor | 52.3 | 54.7 | ||||
| Bone marrow blasts, % | 10.00 (1.0-19.0) | 8.00 (0.5-18.5) | ||||
| Bone marrow blast % category | ||||||
| ≤2 | 2.4 | 4.8 | ||||
| >2 to <5 | 11.9 | 7.1 | ||||
| 5-10 | 35.7 | 57.1 | ||||
| >10 | 47.6 | 28.6 | ||||
| Main WHO classes* | ||||||
| RAEB-1 | 31.0 | 38.1 | ||||
| RAEB-2 | 40.5 | 35.7 | ||||
| Others | 26.2 | 19.1 | ||||
| TP53 mutation status† | ||||||
| Wild-type | 67.0 | 70.0 | ||||
| Mutated | 33.0 | 30.0 | ||||
| . | Arm A (azacitidine + durvalumab) (n = 42) . | Arm B (azacitidine monotherapy) (n = 42) . | ||||
|---|---|---|---|---|---|---|
| No. . | % . | Median (range) . | No. . | % . | Median (range) . | |
| Age, y | 73.0 (46-83) | 74.5 (57-89) | ||||
| Sex | ||||||
| Male | 28 | 30 | ||||
| Female | 14 | 12 | ||||
| ECOG status | ||||||
| 0 | 40.5 | 42.9 | ||||
| 1 | 47.6 | 47.6 | ||||
| 2 | 7.1 | 9.5 | ||||
| Hemoglobin, g/L | 91.5 (54-125) | 89.0 (38-129) | ||||
| Transfusion burden, units/28 d | 0.50 (0.0-7.0) | 2.00 (0.0-8.0) | ||||
| Platelet count × 109/L | 55.0 (5-347) | 46.5 (11-355) | ||||
| Low platelets (<100 000) | 0 | 0 | ||||
| ANC × 109/L | 0.990 (0.03-14.22) | 0.965 (0.10-7.99) | ||||
| Low ANC (<100) | ||||||
| Band form | 0 | 0 | ||||
| Segmented | 29 | 76 | 33 | 83 | ||
| Time since diagnosis, months | 2.1 (0.4-93.8) | 2.5 (0.0-42.1) | ||||
| MDS | ||||||
| Primary | 88.1 | 95.2 | ||||
| Secondary | 11.9 | 4.8 | ||||
| IPSS-R risk category (central)* | ||||||
| Intermediate | 2.4 | 7.1 | ||||
| High | 42.9 | 38.1 | ||||
| Very high | 47.6 | 50.0 | ||||
| IPSS-R cytogenetic risk category | ||||||
| Good/very good | 26.2 | 26.2 | ||||
| Intermediate | 21.4 | 19.0 | ||||
| Poor/very poor | 52.3 | 54.7 | ||||
| Bone marrow blasts, % | 10.00 (1.0-19.0) | 8.00 (0.5-18.5) | ||||
| Bone marrow blast % category | ||||||
| ≤2 | 2.4 | 4.8 | ||||
| >2 to <5 | 11.9 | 7.1 | ||||
| 5-10 | 35.7 | 57.1 | ||||
| >10 | 47.6 | 28.6 | ||||
| Main WHO classes* | ||||||
| RAEB-1 | 31.0 | 38.1 | ||||
| RAEB-2 | 40.5 | 35.7 | ||||
| Others | 26.2 | 19.1 | ||||
| TP53 mutation status† | ||||||
| Wild-type | 67.0 | 70.0 | ||||
| Mutated | 33.0 | 30.0 | ||||