Patients HCP
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Study design

For adults with newly diagnosed Ph+ CML-CP

An innovative study of initial TKI treatment1

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. 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

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: Study end points1,2

A graphic highlighting how ASC4FIRST examined multiple end points across each IS-TKI stratum.

ASC4FIRST: A study design that reflects clinical practices2

This unique study design allowed physicians to select from locally approved comparator TKIs available to their patients with PH+ CML-CP. Additionally, it allowed them to modify doses per local approved Prescribing Information based on patient needs, tolerability, and response to treatment.
Key baseline characteristics1:
Chart indicating the key baseline characteristics between specific demographics.

2G, 2nd generation; bid, twice daily; ELTS, EUTOS long-term survival; EUTOS, EUropean Treatment Outcome Study; 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.

References: 1. Scemblix. Prescribing information. Novartis Pharmaceuticals Corp. 2. Data on file. CABL001J12301 clinical study report (Week 48 analysis). Novartis Pharmaceuticals Corp; 2022.