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ASCEMBL

A Phase 3, Multi-center, Open-label, Randomized Study of Oral ABL001 Versus Bosutinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase (CML-CP), Previously Treated With 2 or More Tyrosine Kinase Inhibitors

Phase 3N = 233NCT03106779

Population
Adults (aged 18 years or older) with CML in chronic phase previously treated with 2 or more ATP-competitive TKIs, with treatment failure (ELN 2013 criteria) or intolerance of the most recent TKI; patients with T315I or V299L BCR::ABL1 mutations before study entry were ineligible
Design
Open-label randomised phase 3 trial, 2:1, stratified by major cytogenetic response status at baseline. Primary objective: compare the major molecular response rate at week 24 for asciminib versus bosutinib.
Primary endpoint
MMR
Arms
  • Bosutinib (control, n = 76): Bosutinib 500 mg once daily
  • Asciminib (experimental, n = 157): Asciminib 40 mg twice daily
People
Réa D, senior author Hochhaus A
Δ MMR+12.3 pointsΔ MMR+21.8 points
Show the numbers
Results reported for ASCEMBL
EndpointAnalysisAsciminibBosutinibEffect
MMRAll randomised patients (157 asciminib, 76 bosutinib)Major molecular response rate at week 24 (primary objective)primarymedian follow-up 14.9 monthsRéa 202125.5%13.2%P=.029Difference in MMR rate 12.2% after adjusting for baseline major cytogenetic response (95% CI 2.19 to 22.30); 2-sided P=.029.
MMRIntent-to-treat population: all randomised patients (157 asciminib, 76 bosutinib)Major molecular response rate at week 96 (key secondary endpoint)long term-updatemedian follow-up 2.3 yearsHochhaus 202337.6%15.8%P=0.001Difference 21.7% after adjusting for baseline major cytogenetic response (95% CI 10.53 to 32.95); two-sided p=0.001.
Results reported for ASCEMBL
EndpointAnalysisAsciminibBosutinibEffect
MMRAll randomised patients (157 asciminib, 76 bosutinib)Major molecular response rate at week 24 (primary objective)primarymedian follow-up 14.9 monthsRéa 202125.5%13.2%P=.029Difference in MMR rate 12.2% after adjusting for baseline major cytogenetic response (95% CI 2.19 to 22.30); 2-sided P=.029.
MMRIntent-to-treat population: all randomised patients (157 asciminib, 76 bosutinib)Major molecular response rate at week 96 (key secondary endpoint)long term-updatemedian follow-up 2.3 yearsHochhaus 202337.6%15.8%P=0.001Difference 21.7% after adjusting for baseline major cytogenetic response (95% CI 10.53 to 32.95); two-sided p=0.001.
Primary publication: Réa D, Mauro MJ, Boquimpani C, Minami Y, Lomaia E, Voloshin S, et al. A phase 3, open-label, randomized study of asciminib, a STAMP inhibitor, vs bosutinib in CML after 2 or more prior TKIs. Blood. 2021;138(21):2031-2041. PubMedDOI

Appears in

Sources

  1. Réa D, Mauro MJ, Boquimpani C, Minami Y, Lomaia E, Voloshin S, et al. A phase 3, open-label, randomized study of asciminib, a STAMP inhibitor, vs bosutinib in CML after 2 or more prior TKIs. Blood. 2021;138(21):2031-2041.

    PubMedDOI

  2. Hochhaus A, Réa D, Boquimpani C, Minami Y, Cortes JE, Hughes TP, et al. Asciminib vs bosutinib in chronic-phase chronic myeloid leukemia previously treated with at least two tyrosine kinase inhibitors: longer-term follow-up of ASCEMBL. Leukemia. 2023;37(3):617-626.

    PubMedDOI