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Adding Ropeginterferon Alpha‐2b to Imatinib for Chronic-Phase CML

By: Julia Fiederlein
Posted: Wednesday, October 7, 2020

According to Josef Thaler, MD, of Klinikum Wels‐Grieskirchen, Austria, and colleagues, the addition of the monopegylated interferon ropeginterferon alpha‐2b to standard chemotherapy with imatinib appears to deepen the molecular response in patients with chronic-phase chronic myeloid leukemia (CML) who did not achieve a deep molecular response with imatinib alone. The results of the phase I trial, which were published in Hematological Oncology, suggested this combination therapy was also well tolerated.

“The activity of interferon alpha is based on a variety of biological activities including antiproliferative, immunomodulatory, and antiangiogenic effects,” the investigators explained. “The use of lower doses of pegylated interferon for longer time periods seems to be preferable over higher doses with respect to adverse events.”

Between August 2013 and June 2018, a total of 12 patients pretreated with imatinib for chronic-phase CML who did not achieve a deep molecular response before initiating combination therapy were enrolled. The investigators defined a deep molecular response as a molecular response of 4.5 or undetectable BCR-ABL1 transcripts. At study entry, the median dose of imatinib was 400 mg. The dose of the ropeginterferon alpha‐2b ranged from 45 to 92 μg, with a mean of 70 μg.

Two patients withdrew from the study early due to adverse events; one patient experienced grade 3 neutropenia, and the other experienced grade 2 panic attacks. According to the investigators, most nonhematologic adverse events were grade 1 or 2. Neutropenia was the most common hematologic adverse event. No new adverse events were identified.

One patient achieved a deep molecular response at 12 months, and four patients achieved a deep molecular response at 18 months (P = .0125). The cumulative doses of ropeginterferon alpha‐2b administered during the first 12 months did not seem to be associated with the achievement of a deep molecular response (all P values > .05).

Disclosure: For full disclosures of the study authors, visit onlinelibrary.wiley.com.



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