BELA
Bosutinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia: results from the BELA trial
Phase 3N = 502NCT00574873
- Population
- Newly diagnosed chronic-phase CML
- Design
- Open-label, randomized (1:1) phase 3 trial of bosutinib 500 mg per day versus imatinib 400 mg per day in newly diagnosed chronic-phase CML.
- Primary endpoint
- CCyR
- Arms
- Bosutinib (experimental, n = 250): Bosutinib 500 mg per day
- Imatinib (control, n = 252): Imatinib 400 mg per day
- People
- Cortes JE, senior author Gambacorti-Passerini C
Δ CCyR+2 pointsΔ MMR+14 pointsΔ 24-month CCyR−1 pointsΔ 24-month MMR+10 points
Show the numbers
| Endpoint | Analysis | Bosutinib | Imatinib | Effect |
|---|---|---|---|---|
| CCyRAll randomized patients (intention-to-treat; n=502)Complete cytogenetic response rate at 12 months (primary endpoint; not met) | primaryCortes 2012 | 70% (64–76%) | 68% (62–74%) | P=0.601Two-sided P; the study did not achieve its primary end point. |
| MMRAll randomized patients (intention-to-treat; n=502)Major molecular response rate at 12 months | primaryCortes 2012 | 41% (35–47%) | 27% (22–33%) | P<0.001Two-sided P. MMR at 12 months was the key secondary endpoint; the primary endpoint was CCyR at 12 months (not met). |
| CCyRAll randomized patients (efficacy analysis of the 24-month report)Cumulative complete cytogenetic response rate by 24 months | long term-updateBrümmendorf 2015 | 79% at 2 y | 80% at 2 y | The 24-month report states that, because the primary objective was not met, its results are considered exploratory and descriptive. |
| MMRAll randomized patients (efficacy analysis of the 24-month report)Cumulative major molecular response rate by 24 months | long term-updateBrümmendorf 2015 | 59% at 2 y | 49% at 2 y | The 24-month report states that, because the primary objective was not met, its results are considered exploratory and descriptive. |
| Endpoint | Analysis | Bosutinib | Imatinib | Effect |
|---|---|---|---|---|
| CCyRAll randomized patients (intention-to-treat; n=502)Complete cytogenetic response rate at 12 months (primary endpoint; not met) | primaryCortes 2012 | 70% (64–76%) | 68% (62–74%) | P=0.601Two-sided P; the study did not achieve its primary end point. |
| MMRAll randomized patients (intention-to-treat; n=502)Major molecular response rate at 12 months | primaryCortes 2012 | 41% (35–47%) | 27% (22–33%) | P<0.001Two-sided P. MMR at 12 months was the key secondary endpoint; the primary endpoint was CCyR at 12 months (not met). |
| CCyRAll randomized patients (efficacy analysis of the 24-month report)Cumulative complete cytogenetic response rate by 24 months | long term-updateBrümmendorf 2015 | 79% at 2 y | 80% at 2 y | The 24-month report states that, because the primary objective was not met, its results are considered exploratory and descriptive. |
| MMRAll randomized patients (efficacy analysis of the 24-month report)Cumulative major molecular response rate by 24 months | long term-updateBrümmendorf 2015 | 59% at 2 y | 49% at 2 y | The 24-month report states that, because the primary objective was not met, its results are considered exploratory and descriptive. |
Appears in
Sources
Cortes JE, Kim DW, Kantarjian HM, Brümmendorf TH, Dyagil I, Griskevicius L, et al. Bosutinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia: results from the BELA trial. J Clin Oncol. 2012;30(28):3486-92.
Brümmendorf TH, Cortes JE, de Souza CA, Guilhot F, Duvillié L, Pavlov D, et al. Bosutinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukaemia: results from the 24-month follow-up of the BELA trial. Br J Haematol. 2015;168(1):69-81.