Scemblix®

Scemblix® is indicated for the treatment of adult patients with:

  • Newly diagnosed or previously treated Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).
  • Ph+ CML in CP harboring the T315I mutation.
  • MMR at Week 24
  • MMR at Week 96
  • MMR at Week 156
    SCEMBLIX® (asciminib) nearly doubled the MMR rate vs bosutinib at Week 24 (primary endpoint)2,4

     

    MMR at Week 24

    Primary endpoint2,4

     

    MMR at Week 24

     

    *On adjustment for the baseline major cytogenetic response status. 
    †Cochran–Mantel–Haenszel two-sided test stratified by baseline major cytogenetic response status.

    Adapted from Réa D, et al. 20212 and Mauro M, et al. 2023.4

    Achieving MMR has been associated with more favourable long-term outcomes, including survival and progression-free survival2,5,6

    Key secondary endpoint

    Reported after a follow-up of 2.3 years2,4

    MMR at Week 962,4

    MMR at Week 96

    *On adjustment for the baseline major cytogenetic response status.
    †Cochran–Mantel–Haenszel two-sided test stratified by baseline major cytogenetic response status.

    Adapted from Réa D, et al. 20212 and Mauro M, et al. 2023.4

    MMR continued to be higher with SCEMBLIX vs bosutinib at Week 962,4

    End of study treatment

    MMR at Week 1562,4

    MMR at Week 156

    *On adjustment for the baseline major cytogenetic response status.
    †Cochran–Mantel–Haenszel two-sided test stratified by baseline major cytogenetic response status.

    Adapted from Réa D, et al. 2021,2 and Mauro M, et al. 2023.4

  • CCyR at Week 24 and Week 96
  • MR4 at Weeks 24, 96 and 156
  • Cumulative incidence of MMR

    More patients receiving SCEMBLIX® (asciminib) may yield CCyR status over time vs bosutinib1

     

    Please note that p values were not formally tested for this analysis

    CCyR at Week 24*1,2

    CCyR at Week 96*1–3

    CCyR at Week 24 and Week 96
    CCyR at Week 24 and Week 96

     

    *CCyR 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).2

    Adapted from Réa D et al. 2021,2 Hochhaus A et al. 20233 and the SCEMBLIX SmPC.1

    CCyR is a predictor of better long-term outcomes7

    With SCEMBLIX® (asciminib), more patients achieved deep MR vs bosutinib at Week 24 through to Week 1562,8

     

    No statistical analysis was available at the time of publication

    Adapted from Réa D, et al. 20212 and Mauro M, et al. 2023.8

    MR4 at Week 242,8

    MR4 at Week 24

    MR4 at Week 968

    MR4 at Week 96

    MR4 at Week 1568

    MR4 at Week 156



     

    Adapted from Réa D, et al. 20212 and Mauro M, et al. 2023.8

    Deep molecular response is defined as MR4 (BCR-ABL1IS ≤0.01%) or better (with MR4.5 BCR-ABL1IS ≤0.0032%)5

    SCEMBLIX® (asciminib) consistently increased cumulative MMR vs bosutinib over time2,4,8

    Cumulative incidence of MMR

    Cumulative incidence of MMR

    *Non-responders were censored at their last molecular assessment date.

    Adapted from Réa D, et al. 2021,2 Mauro M, et al. 20234 and Mauro M, et al. 2023.8

    SCEMBLIX achieved higher MMR rates vs bosutinib throughout the duration of the study2,4

    The most common AEs of any grade (incidence ≥20%) in patients receiving SCEMBLIX were musculoskeletal pain (38.8%), upper respiratory tract infections (29.5%), fatigue (28.9%), thrombocytopenia (28.1%), headache (26.4%), arthralgia (24.4%), increased pancreatic enzymes (23%), diarrhoea (22.5%), abdominal pain (22.2%), rash (21.6%), hypertension (20.8%) and nausea (20.8%). For further information, please refer to the Summary of Product Characteristics.

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 inhibitor.


References

  1. SCEMBLIX (asciminib) Summary of Product Characteristics.
  2. Réa D, et al. Blood 2021;138(21):2031–2041 (and supplementary appendix).
  3. Hochhaus A, et al. Leukemia 2023;37:617–626 (and supplementary appendix).
  4. Mauro M, et al. Blood 2023;142 (Supplement 1):4536–4539.
  5. Hehlmann R, et al. Leukemia 2017;31(11):2398–2406.
  6. Castagnetti F, et al. Leukemia 2015;29(9):1823–1831.
  7. Jabbour E, et al. Blood 2011;118(17):4541–4546.
  8. Mauro M, et al. Poster 4536. 65th ASH Annual Meeting & Exposition; December 9–12, 2023; San Diego, California, & virtual.