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SCEMBLIX®▼ (asciminib) showed superior efficacy vs bosutinib as early as Week 241,2
ASCEMBL is the first head-to-head Phase 3 study comparing a STAMP inhibitor vs an ATP-competitive TKI.2,3
A multicentre, randomised, active-controlled and open-label Phase III study of SCEMBLIX vs bosutinib, assessing MMR at 24 and 96 weeks, and other endpoints including time to and duration of MMR, CCyR and safety.2,4
The ASCEMBL trial population was not restricted to Ph+ patients with CML-CP.2 SCEMBLIX is indicated in adults with Ph+ CML-CP previously treated with two or more TKIs and without a known T315I mutation.1
SCEMBLIX nearly doubled the MMR rate vs bosutinib at Week 24 (primary endpoint)1
MMR at Week 24
Primary endpoint1,2
aOn adjustment for the baseline major cytogenetic response status.
bCochran-Mantel-Haenszel two-sided test stratified by baseline major cytogenetic response status.
Adapted from Réa D, et al. 2021.2
Achieving MMR has been associated with superior long-term outcomes, including survival and progression-free survival.4–6
Key secondary endpoint
Reported after a follow-up of 2.3 years1,3,7
MMR at Week 961,3,7
aOn adjustment for the baseline major cytogenetic response status.
MMR continued to be higher with SCEMBLIX vs bosutinib at Week 96.1,3,7
More patients receiving SCEMBLIX may yield CCyR status over time vs bosutinib1
Please note that p values were not formally tested for this analysis
CCyR at Week 24a,1,2
CCyR at Week 96a,1–3
aCCyR analysis based on 103 of 157 patients (65.6%) receiving SCEMBLIX and 62 of 76 (81.6%) receiving bosutinib who did not have this level of response at baseline. Key secondary efficacy and safety results were reported after a median follow-up of 2.3 years (16.5 months of additional follow-up since primary analysis).3
Adapted from Réa et al. 2021, Hochhaus et al. 2023 and the SCEMBLIX SmPC.1–3
CCyR is a predictor of better long-term outcomes.8
With SCEMBLIX, more patients may demonstrate deep MR vs bosutinib at Weeks 24 and 962,3
No statistical analysis was available at the time of publication.
MR4 or deeper at week 242
Adapted from Réa D, et al. 2021 and Hochhaus A, et al. 2023.2,3
MR4 at week 963
Deep molecular response is defined as MR4 (BCR-ABL1IS ≤0.01%) or better (with MR4.5 BCR-ABL1IS ≤0.0032%).5
SCEMBLIX consistently increased cumulative MMR vs bosutinib over time2,3
Cumulative incidence of MMR
Adapted from Réa D, et al. 2021 and Hochhaus A, et al. 2023.2,3
SCEMBLIX achieved higher MMR rates vs bosutinib throughout the duration of the study.3
SCEMBLIX resulted in fewer all-grade and grade ≥3 AEs vs bosutinib2,3
AE, adverse event; ATP, adenosine triphosphate; BCR-ABL, breakpoint cluster region and Abelson murine leukaemia viral oncogene homologue; CCyR, complete cytogenetic remission; CI, confidence interval; CML-CP, chronic myeloid leukaemia in chronic phase; IS, international scale; MCyR, major cytogenetic response; MMR, major molecular response; MR, molecular response; Ph+, Philadelphia chromosome positive; STAMP, specifically targeting the ABL1 myristoyl pocket; TKI, tyrosine kinase.
SCEMBLIX is indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia (Ph + CML) in chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors, and without a known T315I mutation.1
For further information please refer to the Summary of Product Characteristics.
References
- SCEMBLIX (asciminib) Summary of Product Characteristics [Accessed July 2023].
- Réa D, et al. Blood 2021 Nov 25;138(21):2031–2041.
- Hochhaus A, et al. Leukemia 2023;37:617–626.
- Réa D, et al. Blood 2021;138(21):2031–2041 (supp appendix).
- Hehlmann R, et al. Leukemia 2017;31(11):2398–2406.
- Castagnetti F, et al. GIMEMA CML Working Party. Leukemia 2015;29(9):1823–1831.
- Hochhaus A, et al. Leukemia 2023;37:617–626 (supp appendix).
- Jabbour E, et al. Blood 2011;118(17):4541–4546.