Asciminib plus imatinib in patients with heavily pre-treated chronic myeloid leukaemia

In a phase 1 trial of asciminib in combination with imatinib in heavily pre-treated patients with Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase (Ph+ CML-CP), 60% (9/15) of participants achieved a molecular response rate <1% in the asciminib+imatinib arm [1].

Asciminib binds the myristate-binding pocket of the Bcr-Abl kinase domain. In the current study, presented by Prof. Jorge Cortes (University of Texas MD Anderson Cancer Center, USA), patients ≥18 years of age had a confirmed diagnosis of CML-CP. Patients had to be on a minimum of 2 years treatment with imatinib first line for CML-CP, BCR-ABL1 levels had to be >0.01% International Scale (IS) and ≤ 1% IS at the time of study entry as confirmed with a central assessment at screening and must not have achieved molecular response (MR)4 IS at any time during prior imatinib treatment.

The primary outcome was MR^4.5 rate between asciminib+imatinib and imatinib alone at 48 weeks. The preliminary results showed that among patients who at baseline did not achieve BCR-ABL1 IS <1%, by 48 weeks, 42% (8/19) achieved major MR with asciminib plus imatinib with median treatment exposure of 54.6 weeks. Furthermore, no patients with major MR at baseline lost response due to the combination therapy. The combination showed a tolerable safety profile in heavily pre-treated CML patients. The most common any-grade adverse events were nausea (32%), increased lipase (20%), as well as abdominal pain, peripheral oedema, and vomiting (16% each).

1. 
   
   1. Cortes J, et al. Abstract S883. 24th Congress of the European Hematology Association. June 13-16, Amsterdam, the Netherlands.

 





Posted on 9 August, 201911 March, 2021