Efficacy

ASC4FIRST STUDY DESIGN

For adults with newly diagnosed Ph+ CML-CP

ASC4FIRST evaluated the efficacy, safety, and tolerability profile of SCEMBLIX vs the current standard of care (1st- and 2nd-generation TKIs) in adults with newly diagnosed Ph+ CML-CP^1,2

ASC4FIRST is a multicenter, randomized, active-controlled, open-label study where investigators, in consultation with patients, preselected the appropriate TKI and evaluated patients' ELTS risk scores. Patients were then stratified by preselected TKI and ELTS score. Once stratified, they were randomized to receive either SCEMBLIX or an Investigator-selected TKI.^1,2

A chart showing the study design and key eligibility criteria for the study. Patients were randomized 1:1 to receive either SCEMBLIX 80 mg qd (n=201) or investigator selected TKIs: (N=204)

^aTreatment with any TKIs prior to randomization was not allowed, except for a period of ≤2 weeks of either imatinib, nilotinib, dasatinib, or bosutinib.²
^bELTS groups included low, intermediate, and high.¹

ASC4FIRST baseline characteristics

A chart showing the key baseline characteristics and demographic characteristics.

Two primary end points¹:

MMR rate at Week 48: SCEMBLIX vs IS-TKIs (all): imatinib, nilotinib, dasatinib, or bosutinib
MMR rate at Week 48: SCEMBLIX vs IS-TKIs (imatinib stratum)

Key secondary end points²:

MMR rate at Week 96: SCEMBLIX vs IS-TKIs (all): imatinib, nilotinib, dasatinib, or bosutinib
MMR rate at Week 96: SCEMBLIX vs IS-TKIs (imatinib stratum)

Select other secondary end points²:

MMR rate at Week 48: SCEMBLIX vs IS-TKIs (2G TKIs stratum): nilotinib, dasatinib, or bosutinib
Time to MMR: SCEMBLIX vs IS-TKIs (all and imatinib stratum)
Safety and tolerability profile

MMR RATES

Superior response rates vs IS-TKIs in newly diagnosed patients¹

MMR rates at Week 48

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 TKIs of 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.

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

Median time to MMR

SCEMBLIX vs 2G TKIs

MMR rate at Week 48: 2G TKIs stratum

A chart showing MMR at Week 48: 2G TKI statum

2G, 2nd generation; bid, twice daily; ELTS, EUTOS long-term survival; 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; qd, once daily; TKI, tyrosine kinase inhibitor.

Learn more about the SCEMBLIX safety and tolerability profile >

Efficacy