Table 5. Early efficacy in the phase 2b portion.
| Best response |
PAN AZA |
AZA |
All patients (N=82) | ||||
|---|---|---|---|---|---|---|---|
| All (n=40) | MDS/CMML (n=31) | AML (n=9) | All (n=42) | MDS/CMML (n=29) | AML (n=13) | ||
| Composite CR, n (%) (95% CI) | 11 (27.5) (14.6–43.9) | 13 (41.9) (24.5–60.9) | 2 (22.2) (2.8–60.0) | 6 (14.3) (5.4–28.5) | 12 (41.4) (23.5–61.1) | 4 (30.8) (9.1–61.4) | 17 (20.7) (12.6–31.1) |
| CR, n (%) | 6 (15.0) | 5 (16.1) | 1 (11.1) | 4 (9.5) | 2 (6.9) | 2 (15.4) | 10 (12.2) |
| BM-CR (MDS/CMML) or CRi (AML), n (%) | 5 (12.5) | 4 (12.9) | 1 (11.1) | 2 (4.8) | 1 (3.4) | 1 (7.7) | 7 (8.5) |
| Median time to progression (95% CI), months | NE (11.1–NE) | NA | NA | 15.2 (11.0–NE) | NA | NA | NE (12.7–NE) |
| Median OS (95% CI), months | 14.9 (10.4–NE) | NA | NA | 15.6 (11.4–NE) | NA | NA | 15.4 (13.0–NE) |
Abbreviations: AML, acute myeloid leukemia; AZA, azacitidine; BM-CR, bone marrow complete response; CMML, chronic myelomonocytic leukemia; CR, complete response; CRi, morphologic CR with incomplete blood count; MDS, myelodysplastic syndromes; NA, not analyzed; NE, not estimable; OS, overall survival; PAN, panobinostat.