Table 2. Minimum Residual Disease Negativity With Complete Response at End of Induction: Response Rates and Durability of Responsea.
Outcomes | Ponatinib (n = 154) | Imatinib (n = 78) | Risk difference (95% CI) | Relative risk (95% CI) | P value |
---|---|---|---|---|---|
Primary end point: MRD-negative complete remission at end of induction, No. (%)b | 53 (34.4) | 13 (16.7) | 0.18 (0.06-0.29) | 2.06 (1.19-3.56)c | .002c |
MRD negativity (MR4) at end of induction, No. (%) | 61 (43.0)d | 15 (22.1)d | 0.21 (0.08-0.34) | 1.94 (1.19-3.17)c | .002c |
Duration of MRD-negative complete remission | n = 53 | n = 13 | |||
Loss-of-response events, No. (%) | 9 (17.0) | 6 (46.2) | |||
Duration, median (95% CI), mo | NE (16.6-NE) | 18.0 (8.4-27.8) | NA | NA |
Abbreviations: MRD, minimal residual disease; NA, not available; NE, not estimable.
Outcomes were evaluated in the population of patients in the intention-to-treat population with p190/p210 dominant isoforms confirmed by the central laboratory.
The composite primary end point required central laboratory–reported MRD negativity (defined as ≤0.01% BCR::ABL1IS [MR4]) and investigator-reported complete remission (bone marrow blast response with hematologic recovery as measured by absolute neutrophil and platelet counts) for ≥4 weeks at the end of induction.
Adjusted relative risks, 95% CIs, and P values were calculated based on a Cochran-Mantel-Haenszel χ2 test, with stratification according to randomization strata (ages 18 to <45 years, ≥45 to <60 years, and ≥60 years).
Among patients with evaluable samples at end of trial cycle 3 (n = 142 for ponatinib and n = 68 for imatinib).