Table 3.
Response rates from PACE (ponatinib Ph+ ALL and CML evaluation)
| CP-CML | Overall (n = 267) | Resistant/intolerant (n = 203) | T315I (n = 64) |
|---|---|---|---|
| MCyR % (95% CI) | 54% (48–60) | 49% (42–56) | 70% (58–81) |
| Median time to MCyR (range) | 84 days (49–334 days) | N/A | N/A |
| CCyR % (95% CI) | 44% (38–50) | 37% (31–44) | 66% (52–77) |
| AP-CML | Overall (n = 83) | Resistant/intolerant (n = 65) | T315I (n = 18) |
|
| |||
| MaHR % (95% CI) | 52% (41–63) | 55% (43–68) | 39% (17–64) |
| Median time to MaHR (range) | 21 days (12–176 days) | N/A | N/A |
| Median duration of MaHR (range) | 9.5 months (1.1–17.7 months) | N/A | N/A |
| CHR % (95% CI) | 44% (33–55) | 45% (32–57) | 39% (17–64) |
| BP-CML | Overall (n = 62) | Resistant/intolerant (n = 38) | T315I (n = 24) |
|
| |||
| MaHR % (95% CI) | 31% (20–44) | 32% (18–42) | 29% (13–51) |
| Median time to MaHR (range) | 29 (12–113 days) | N/A | N/A |
| Median duration of MaHR (range) | 4.7 months (1.8–14.1+ months) | N/A | N/A |
| CHR % (95% CI) | 21% (12–33) | 24% (11–40) | 17% (5–37) |
| Ph+ ALL | Overall (n = 32) | Resistant/intolerant (n = 10) | T3151 (n = 22) |
|
| |||
| MaHR % (95% CI) | 41% (24–59) | 50% (19–81) | 36% (17–59) |
| Median time to MaHR (range) | 20 (11–168 days) | N/A | N/A |
| Median duration of MaHR (range) | 3.2 months (1.8–8.8+ months) | N/A | N/A |
| CHR % (95% CI) | 34% (19–53) | 40% (12–74) | 32% (14–55) |
Abbreviations: AP-CML, accelerated phase CML; BP-CML, blast phase CML; CCyR, complete cytogenetic response; CHR, complete hematologic response; CI, confidence interval; CML, chronic myeloid leukemia; MaHR, major hematologic response; MCyR, major cytogenetic response; Ph+ ALL, Philadelphia chromosome positive acute lymphoblastic leukemia; CP, chronic phase.