Table 1.
Patient characteristics for Azacitidine+Nivolumab patients (N=70) and for historic HMA-based clinical trial control (N=172).
| Characteristic | N (%); Median [Range] |
||
|---|---|---|---|
| Azacitidine+Nivolumab | Control | Pvalue | |
| Age, years | 70 [22 – 90] | 64 [18 – 90] | 0.004 |
| Age ≥ 60 years | 56 (80) | 103 (60) | |
| Diagnosis, n (%) | |||
| AML- de novo | 39 (56) | 112 (65) | 0.19 |
| Secondary AML | 31 (44) | 60 (35) | |
| Prior therapies | 2 [1 – 7] | 1 [1 – 6] | 0.76 |
| Prior therapiesᵻ | |||
| HMA-based | 45 (64) | 51 (30) | <0.0001 |
| HIDAC | 27 (39) | 99 (58) | 0.0073 |
| IDAC | 21 (30) | 5 (3) | <0.0001 |
| Targeted therapies* | 33 (47) | 15 (9) | <0.0001 |
| Prior allogeneic SCT | 13 (19) | 16 (9) | 0.0441 |
| BM blast | 35 [4 – 94] | 38 [7 – 98] | <0.0001 |
| White blood cell count (x109/L) | 2.7 [0.5 – 81] | 2.4 [0.2 – 232] | 0.9121 |
| Platelets (x109/L) | 28 [1–203] | 25 [1–816] | 0.2379 |
| Cytogenetics | |||
| Diploid | 9 (13) | 23 (13) | 0.9146 |
| Miscellaneous | 36 (51) | 27 (16) | |
| Not available | 0 (0) | 62 (36) | |
| Del 5/−7/complex | 25 (36) | 60 (35) | 0.9023 |
| Molecular mutational panel | Done on all 70 pts | Positive/Total tested | |
| TP53 | 16 (23) | 18/54 (33) | 0.1948 |
| DNMT3A | 12 (17) | 7/58 (12) | 0.4215 |
| TET2 | 11 (16) | 20/32 (63) | <0.0001 |
| ASXL1 | 11 (16) | 13/38 (34) | 0.0272 |
| CEBPA | 8 (11) | 9/81 (11) | 0.9509 |
| RAS | 9 (13) | 8/123 (7) | 0.1343 |
| IDH2 | 9 (13) | 5/62 (8) | 0.3721 |
| PTPN11 | 7 (10) | 1/27 (4) | 0.3123 |
| IDH1 | 6 (9) | 7/82 (9) | 0.9939 |
| JAK2 | 3 (4) | 9/62 (15) | 0.0413 |
| Treatment group | |||
| HMA single agent | 0 (0) | 64 (37) | |
| HMA+Immuntherapy | 70 (100) | 49 (29) | |
| HMA+others | 0 (0) | 59 (34) | |
*
This included IDH1/2 and FLT3-inhibitor, BCL-2 inhibitor, MEK inhibitor, histone deacetylase inhibitor, JAK2 inhibitor, and Grb-2 inhibitor based therapies.
ᵻ
Patients might have received multiple different type of targeted, HMA, HIDC or IDAC therapy. The number and percentage do represent patients, not a percentage from total prior therapy.
Abbreviations: N, number, HMA, hypomethylating agent, Ara-C, cytarabine, BM, bone marrow, Del, deletion, SCT: Stem Cell Transplant, HIDAC: High dose Ara-C based, IDAC: Intermediate dose Ara-C based.