Table 3.
Response outcomes for ven-idasa
| n (%) | DE |
DSO |
Total, n = 56 | |||
|---|---|---|---|---|---|---|
| ven 400 mg + idasa 200 mg, n = 6 |
ven 600 mg + idasa 150 mg and ven 600 mg + idasa 200 mg, n = 35 |
ven 400 mg + idasa 400 mg, n = 9 |
Total, n = 50 | ven 600 mg (D1–21) + idasa 150 mg, n = 6 | ||
| Antileukemic responders (CRc/PR/MLFS) | 1 (16.7) | 17 (48.5) | 2 (22.2) | 20 (40.0) | 2 (33.3) | 22 (39.3) |
| CRc (CR/CRi/CRp) | 1 (16.7) | 12 (34.3) | 0 (0.0) | 13 (26.0) | 2 (33.3) | 15 (26.8) |
| CR | 0 (0.0) | 3 (8.6) | 0 (0.0) | 3 (6.0) | 1 (16.7) | 4 (7.1) |
| CRi | 0 (0.0) | 1 (2.9) | 0 (0.0) | 1 (2.0) | 0 (0.0) | 1 (1.8) |
| CRp | 1 (16.7) | 8 (22.9) | 0 (0.0) | 9 (18.0) | 1 (16.7) | 10 (17.9) |
| PR | 0 (0.0) | 0 (0.0) | 1 (11.1) | 1 (2.0) | 0 (0.0) | 1 (1.8) |
| MLFS | 0 (0.0) | 5 (14.3) | 1 (11.1) | 6 (12.0) | 0 (0.0) | 6 (10.7) |
| Time to best CRc response, median (range) | 1.3 (1.3-1.3) | 1.5 (0.8-4.3) | NE | 1.4 (0.8-4.3) | 3.2 (1.6-4.8) | 1.6 (0.8-4.8) |
| Median DoR (CRc), median (range) | NE (0.7∗–0.7∗) | 5.5 (2.3, 8.8) | NE | 3.9 (0.7∗–12.5) | NE (1.0-1.2∗) | 3.0 (0.7∗–12.5) |
| Median follow-up, median (range) | 2.3 (1.6-21.9) | 5.3 (0.0-23.3) | 2.8 (0.4-14.4) | 3.9 (0.0-23.3) | 4.4 (3.0-5.8) | 4.0 (0.0-23.3) |
D, day; NE, not evaluable; PR, partial response.
∗
Censored, response is ongoing before patient dropout. Efficacy data are presented for the intent-to-treat population.