Now available for adults with newly diagnosed Ph+ CML-CP
SCEMBLIX was studied vs all* standard-of-care TKIs in patients with newly diagnosed Ph+ CML-CP in ASC4FIRST
ASC4FIRST is a multicenter, randomized, active-controlled, open-label study of 405 adults with newly diagnosed Ph+ CML-CP. Investigators, in consultation with patients, preselected the appropriate TKI and evaluated ELTS risk scores. Patients were then stratified by TKI and ELTS score, then randomized (1:1) to receive either SCEMBLIX or an Investigator-selected TKI (imatinib, nilotinib, bosutinib, or dasatinib). 201 patients received SCEMBLIX at 80 mg qd, and 204 patients received IS-TKIs until unacceptable toxicity or treatment failure occurred.1,2
*Imatinib, nilotinib, dasatinib, and bosutinib.
Efficacy
MMR rate at Week 48
- 68% (95% CI, 61-74) for patients receiving SCEMBLIX (n=201) vs 49% (95% CI, 42-56) for patients receiving IS-TKIs† (all) (n=204) (difference: 19% [95% CI,‡ 10-28; P<0.001§])1 (primary end point)
- 69% (95% CI, 59-78) for patients receiving SCEMBLIX (n=101) vs 40% (95% CI, 31-50) for patients receiving IS-TKIs† (imatinib stratum) (n=102) (difference: 30% [95% CI,‡ 17-42; P<0.001¶])1 (primary end point)
MMR was defined as BCR::ABL1IS ≤0.1% (≥3.0 log reduction).1,2
SCEMBLIX was evaluated across multiple end points vs IS-TKIs, including median time to MMR and MR4 by Week 48.2
†IS-TKIs included 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).
‡Estimated using a common risk difference stratified by PRS-TKI and baseline ELTS risk groups.
§Adjusted P-value using a Cochran-Mantel-Haenszel 1-sided test stratified by PRS-TKI and baseline ELTS risk groups.
¶Adjusted P-value using a Cochran-Mantel-Haenszel 1-sided test stratified by baseline ELTS risk groups.
Safety and tolerability profile
Permanent discontinuation due to ARs (all-grade) at Week 48:
4.5% of patients receiving SCEMBLIX (n=200) discontinued treatment due to ARs, compared to 10.4% of patients receiving IS-TKIs (all) (n=201).3
- Dosage interruptions of SCEMBLIX due to an AR occurred in 30% of patients
- Dose reductions of SCEMBLIX due to an AR occurred in 6% of patients
The most common AR (≥20%) in patients who received SCEMBLIX was musculoskeletal pain.1
Serious ARs occurred in 11% of patients who received SCEMBLIX. Serious ARs in ≥1% included pancreatitis (1%) and musculoskeletal pain (1%).1
AR, adverse reaction; 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.