Dasatinib Plus Peg-IFN-Alpha2b Appears Safe, Effective in Patients With Newly Diagnosed CML

Combining dasatinib and pegylated-interferon-alpha 2b (Peg-IFN-alpha2b) may be an effective method for inducing deep molecular responses (DMRs) among patients with newly diagnosed chronic myeloid leukemia (CML), according to research published in the British Journal of Haematology.

Previous research has suggested that combining tyrosine kinase inhibitors (TKIs) with Peg-IFN may be an effective strategy among patients with newly diagnosed CML. Patients who received IFN prior to TKIs, for example, had longer major molecular responses than others did in the previous EURO-SKI study.

Dasatinib is a second-generation TKI that was approved by the US Food and Drug Administration for newly diagnosed patients with CML in chronic phase (CP-CML). For this phase 2 study (ClinicalTrials.gov Identifier: NCT01872442), researchers explored whether combining dasatinib and Peg-IFN-alpha2b is safe and effective among patients with newly diagnosed CP-CML.

The primary endpoint was the cumulative MR 4.5 log (MR^4.5) rate by 12 months, which is indicative of DMR. In the present paper, the authors reported data for the study’s 5-year duration.

Overall, 79 patients were enrolled to this study. The median patient age was 48 years (range, 20-65), 56% of patients were male sex, and 9% of patients had high-risk additional cytogenetic abnormalities.

At months 12 and 24, the MR^4.5 rates were 25% and 38%, respectively. After this point, 32% and 46% of patients, respectively, had MR^4.5 or MR⁴ for at least 2 years.

Grade 3 or 4 neutropenia was noted in 38% of patients, of whom 1 developed a grade 3 infection. No other grade 3 or 4 adverse events were noted in more than 10% of patients.

“In conclusion, this study demonstrated the efficacy and manageable safety of the combination of dasatinib and PegIFN in newly diagnosed CP-CML,” the authors wrote in their report. “A high rate of early and sustained DMR was achieved, supporting the use of this initial combination therapy for CP-CML.”

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, or device companies. Please see the original reference for a full list of authors’ disclosures. 

Reference

Roy L, Chomel JC, Guilhot J, et al. Dasatinib plus Peg-Interferon alpha 2b combination in newly diagnosed chronic phase chronic myeloid leukaemia: Results of a multicenter phase 2 study (DASA-PegIFN study). Br J Haematol. Published online October 10, 2021. doi:10.1111/bjh.18486