Clinical trial results

MMR RATES

For adults with newly diagnosed Ph+ CML-CP

Superior response rates vs all current standard-of-care TKIs in newly diagnosed patients¹

A graph showing the MMR rate at week 48 for SCEMBLIX vs IS-TKIs (all) and MMR rate at week 48 for SCEMBLIX vs IS-TKIs (imatinib).

^aEstimated using a common risk difference stratified by PRS-TKI and baseline ELTS risk groups.
^bAdjusted P-value using a Cochran-Mantel-Haenszel 1-sided test stratified by PRS-TKI and baseline ELTS risk groups.
^cIS-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).
^dAdjusted P-value using a Cochran-Mantel-Haenszel 1-sided test stratified by baseline ELTS risk groups.

More than 2/3 of patients attained MMR at Week 48 with SCEMBLIX.

The median duration of follow-up was 16.3 months for patients receiving SCEMBLIX, and 15.7 months for patients receiving IS-TKIs.²

The median duration of treatment was 70 weeks (range, 1-108 weeks) for patients receiving SCEMBLIX, and 64 weeks (range, 1-103 weeks) for patients receiving IS-TKIs.¹

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

MEDIAN TIME TO MMR

SCEMBLIX worked fast¹

MR2 AND EMR RATES

SCEMBLIX: Observed MR2 and EMR rates

Line graph indicating the MR2 rate by scheduled time points.

Graphic highlighting the early molecular response rate (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

SCEMBLIX: MR4 rates

Bar graph indicating the MR4 rate for SCEMBLIX and IS-TKIs (all) by Week 48

MR4 rate for SCEMBLIX and IS-TKIs (imatinib) by Week 48: 46% (n=46/101) and 16% (n=16/102), respectively²

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

SCEMBLIX VS 2G TKIs

Efficacy for SCEMBLIX and IS-TKIs (2G TKIs)

Select other secondary end points and post-hoc analysis

Graphic indicating statistics such as the MMR rates at week 48, median time to MMR, MR4 rates by week 48, observed MR2 rates, and observed EMR rates.

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 the SCEMBLIX safety and tolerability profile >

Clinical trial results