Clinical Trial Results | SCEMBLIX® (asciminib)

MMR RATES

For adults with newly diagnosed Ph+ CML-CP

SCEMBLIX delivered superior response rates at Week 48 and 96¹

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

MMR was defined as BCR::ABL1^IS ≤0.1% (≥3.0 log reduction).^1,2

Median duration of follow-up³

At Week 96:

26.9 months for SCEMBLIX
26.3 months for IS-TKIs

Median duration of treatment¹

At Week 96:

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

MEDIAN TIME TO MMR

SCEMBLIX worked fast¹

MR2 AND EMR RATES

Observed MR2 and EMR rates for SCEMBLIX and standard-of-care TKIs^2,3

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

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

MR2 was defined as BCR::ABL1^IS ≤1%.²
EMR was defined as BCR::ABL1^IS ≤10% at 12 weeks.²

MR4 RATES

MR4 rates for SCEMBLIX and standard-of-care TKIs by Week 96³

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

MR4 was defined as BCR::ABL1^IS ≤0.01%.²

Deep molecular response can be an important milestone in the treatment journey.

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 Week 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