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The ASCEMBL trial: efficacy


ASCEMBL is the first head-to-head Phase 3 study comparing a CML treatment vs bosutinib, a 2nd-generation TKI1,3,9
 

A multicentre, randomised, active-controlled and open-label Phase 3 study of SCEMBLIX vs bosutinib, assessing MMR at 24 and 48 weeks , and other endpoints including MMR, CCyR and safety.1,10

  • MMR at Week 48
  • MMR at Week 24

    SCEMBLIX nearly doubled the MMR rate vs bosutinib at Week 24 (primary endpoint)1

     

    Achieving MMR has been associated with superior long-term outcomes, including survival and progression-free survival.1

     

    MMR at Week 24 [primary endpoint]1

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    MMR Continues to be higher with SCEMBLIX vs bosutinib at week 4810

     

    MMR at week 483

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  • Cumulative incidence of MMR
  • MR4 at week 24 and 48

    SCEMBLIX consistently increased cumulative MMR vs bosutinib over time1,2

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    With SCEMBLIX, more patients are likely to achieve deep molecular response vs bosutinib at weeks 24 and 481

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SCEMBLIX demonstrated a favourable safety profile vs bosutinib 1,6

LEARN MORE

AE, adverse event; CML, chronic myeloid leukaemia; MOA, mechanism of action; MMR, major molecular remission; Ph+ CML-CP, Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase; STAMP, Specifically Targeting the ABL1 Myristoyl Pocket; TKI, tyrosine kinase inhibitor; URTI, upper respiratory tract infection. CCyR, complete cytogenetic remission; CML-CP, chronic myeloid leukaemia in chronic phase; IS, international scale; MCyR, major cytogenetic response; MMR, major molecular response; STAMP, specifically targeting the ABL1 myristoyl pocket; TKI, tyrosine kinase.

 

SCEMBLIX is indicated for the treatment of patients 18 years of age and above with:

  • Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).
  • Previously treated Ph+ CML in CP.
  • Ph+ CML in CP with the T315I mutation

SCEMBLIX™  20mg and 40mg NSS

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References

  1. Réa D, Mauro MJ, Boquimpani C, et al. Blood. 2021 Nov 25;138(21):2031-2041.

  2. Mauro MJ, Minami Y, Rea D et al. Presented at: American Society for Hematology 63rd Annual Meeting; December11-14, 2021 [Oral presentation 310].

  3. Kantarjian HM, Giles FJ, Bhalla KN, et al. Blood 2011;117(4):1141-1145.

  4. O'Brien SG, Guilhot F, Larson RA, et al. N Engl J Med. 2003;348(11):994-1004.

  5. Saglio G. Kim D-W, Issaragrisil S. et al N Engl J Med.2010;362(24):2251-2259.

  6. Kantarjian H, Shah NP. Hochhaus A, et al. N Engl J Med. 2010 ; 362(24):2260-2270.

  7. Cortes JE, Gambacorti-Passerini C, Deininger MW, et al. J Clin Oncol. 2018;36(3):231237.

  8. Cortes JE, Kantarjian HM, Brümmerorf TH, et al. Blood 2011;118(17):4567-4576.

  9. Shah NP. Kantarjian HM, Kin DW, et al. J Clin Oncol. 2008:26(19):3204-3212.

  10. Data on file. ABL001A: ASCEMBL (A2301). Novartis Pharmaceuticals Corp; 2020.

  11. Smith G, Apperley J, Milojkovic D, et al. Br J Haematol. 2020 Oct;191(2):171-193.

  12. Hochhaus, A., Baccarani, M., Silver, R.T. et al. Leukemia. 2020;34:966–984.

  13. SCEMBLIX (asciminib) approved Product Information.