Clinical trial results

MMR RATES

For adults with newly diagnosed Ph+ CML-CP

MMR rates for SCEMBLIX and standard-of-care* TKIs^1,2

*Imatinib, nilotinib, dasatinib, and bosutinib.

MMR rates at Week 48 and Week 96 for Scemblix and IS-TKIs (all)

MMR rates at Week 48 and Week 96 for Scemblix and IS-TKIs (imatinib)

^aEstimated using a common risk difference stratified by PRS-TKI and baseline ELTS risk groups.¹
^bAdjusted P-value using a Cochran-Mantel-Haenszel 1-sided test stratified by PRS-TKI and baseline ELTS risk groups.¹
^cStandard-of-care (SoC) TKIs include imatinib (400 mg once daily) and other 2nd-generation TKIs: nilotinib (300 mg twice daily), dasatinib (100 mg once daily), or bosutinib (400 mg once daily).¹
^dAdjusted P-value using a Cochran-Mantel-Haenszel 1-sided test stratified by baseline ELTS risk groups.¹

Median duration of follow-up^2,3

At Week 48³:

16.3 months for SCEMBLIX
15.7 months for IS-TKIs

At Week 96²:

26.9 months for SCEMBLIX
26.3 months for IS-TKIs

Median duration of treatment^1,2

At Week 48¹:

70 weeks (range, 1-108 weeks) for SCEMBLIX
64 weeks (range, 1-103) for IS-TKIs

At Week 96²:

27 months (range, 0.2-36 months) for SCEMBLIX
25 months (range, 0.3-35 months) for IS-TKIs

MMR was defined as BCR::ABL1^IS ≤0.1% (≥3.0 log reduction).^1,3

MEDIAN TIME TO MMR

SCEMBLIX worked fast¹

MR2 AND EMR RATES

Observed MR2 and EMR rates for SCEMBLIX and standard-of-care TKIs³

Graph displaying the MR2 rate by scheduled time points for Scemblix vs. IS-TKIs (all).

Graphic highlighting the early molecular response rates (post-hoc analysis).

MR2 was defined as BCR::ABL1^IS ≤1%.³
EMR was defined as BCR::ABL1^IS ≤10% at 12 weeks.³

MR4 RATES

MR4 rates for SCEMBLIX and standard-of-care TKIs^2,3

MR4 rate for Scemblix and IS-TKIs (all) by Week 48 and Week 96.

MR4 rate for SCEMBLIX and IS-TKIs (imatinib) by Week 48 and Week 96.

MR4 was defined as BCR::ABL1^IS ≤0.01%.³

SCEMBLIX VS 2G TKIs

Efficacy for SCEMBLIX and standard-of-care TKIs (2G TKIs)^1-3

Select other secondary end points and post-hoc analysis

Graphic detailing MMR rates at Weeks 48 and 96, median time to MMR, observed MR2 rates and MR4 rates by Weeks 48 and 96.

2G, 2nd generation; ELTS, EUTOS long-term survival; EMR, early molecular response; EUTOS, EUropean Treatment Outcome Study; IS, International Scale; IS-TKI, Investigator-selected tyrosine kinase inhibitor; MMR, major molecular response; MR, molecular response; Ph+ CML-CP, Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase; PRS-TKI, prerandomization selection of tyrosine kinase inhibitor; TKI, tyrosine kinase inhibitor.

Learn more about safety in newly diagnosed patients

Clinical trial results