Efficacy

In an ongoing Phase 3 trial of adult patients with newly diagnosed CP Ph+ CML, 
BOSULIF demonstrated greater rates of molecular and cytogenetic responses vs imatinib1
In an ongoing Phase 3 trial of adult patients with newly diagnosed CP Ph+ CML

MMR and CCyR

Higher rate of MMR (mITT population)1
BOSULIF significantly improved MMR at 12 months
Higher rate of CCyR (mITT population)1
BOSULIF significantly improved CCyR by 12 months
Treatment with BOSULIF helps keep transformation rates low1
After a minimum of 12 months of follow-up
transformed to AP or BP CML while on treatment
aDerived from Cochran-Mantel-Haenszel test stratified by geographical region and Sokal score at randomization; P values are 2-sided.1
AP=accelerated phase; BP=blast phase; CCyR=complete cytogenetic response; mITT=modified intent-to-treat; MMR=major molecular response; Ph+=Philadelphia chromosome–positive.
References
1.
BOSULIF Prescribing Information. New York, NY: Pfizer Inc.

Additional endpoints

More patients reached the 12-month MMR treatment milestone with BOSULIF vs imatinib1-3
In the BFORE study, MMR at 12 months was a primary endpoint and MMR at 3, 6, and 9 months was a prespecified exploratory analysis
This prespecified analysis was exploratory and not powered to detect statistical significance. Small patient numbers and lack of multiplicity adjustments can be a limitation of this analysis. No conclusion of efficacy can be drawn from these data.

Rates of MR4 and MR4.5 were prespecified exploratory analyses2,3
These prespecified analyses were exploratory and not powered to detect statistical significance. Small patient numbers and lack of multiplicity adjustments can be a limitation of these analyses. No conclusion of efficacy can be drawn from these data.

BFORE=Bosutinib Trial in First-Line Chronic Myelogenous Leukemia Treatment; MMR=major molecular response; MR=molecular response; Ph+=Philadelphia chromosome–positive.
References
1.
BOSULIF Prescribing Information. New York, NY: Pfizer Inc.
2.
Cortes JE, Gambacorti-Passerini C, Deininger MW, et al. Bosutinib versus imatinib for newly diagnosed chronic myeloid leukemia: results from the randomized BFORE trial. J Clin Oncol. 2018;36(3):231-237.
3.
Data on file. Pfizer Inc, New York, NY.