Deep responses with asciminib in CML-CP  

Asciminib was an efficacious treatment for patients with chronic myeloid leukaemia in chronic phase (CML-CP) who had received at least 2 prior tyrosine kinase inhibitors (TKI), long-term results of the phase 3 ASCEMBL trial showed, further supporting that this agent is a new standard of care for this population.

Asciminib is the first BCR::ABL1 inhibitor that specifically targets the ABL myristoyl pocket. The ongoing phase 3 ASCEMBL trial (NCT03106779) randomised 214 participants with CML-CP 2:1 to asciminib (40mg twice daily) or bosutinib (500mg once daily). In the published primary analysis of the ASCEMBL trial, asciminib was superior to bosutinib regarding efficacy and safety in participants who had received ≥2 prior TKIs (n=84) [1]. The current analysis aimed to characterise the efficacy of asciminib versus bosutinib and to examine factors associated with response [2]. Prof. Timothy Hughes (University of Adelaide, Australia) presented the findings.

At week 96, the asciminib group comprised more patients who achieved BCR::ABL1^IS <1% after having received at least 1 prior TKI than in the bosutinib group (47.2% vs 23.5%). The major molecular remission (MMR) rate was higher in asciminib-treated participants than in bosutinib controls (37.5% vs 21.1%) at week 96. The corresponding results for participants who had received at least 2 TKIs were similar. Among participants receiving asciminib with BCR::ABL1^IS >0.1% by week 24 who remained on asciminib beyond week 24 (n=56), the cumulative incidence of MMR was 17.9% by 1 year and 37.9% by 2 years, showing that MMR could still be achieved by later timepoints. Finally, the cumulative incidence of MMR and deep molecular response (DMR) was higher in the asciminib arm than in the bosutinib arm in the subset of participants who discontinued their last TKI due to a lack of efficacy.

No new on-treatment deaths were reported since the primary analysis.

These data further support asciminib as a standard of care for patients with CML-CP who had received at least 2 prior TKIs.

1. Réa D, et al. Blood. 2021;138(21):2031─2041
2. Hughes TP, et al. Rapid and deep responses with asciminib in patients with chronic myeloid leukemia in chronic phase after ≥ 2 prior tyrosine kinase inhibitors in the phase 3 ASCEMBL study. P665, EHA 2023 Annual Congress, 8─11 June, Frankfurt, Germany.

Copyright ©2023 Medicom Medical Publishers



Posted on 2 August 20237 September 2023