Chronic Myeloid Leukemia Coverage from Every Angle
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Nilotinib Plus Pegylated Interferon in First-Line Treatment of CML

By: Joseph Fanelli
Posted: Wednesday, January 29, 2020

According to per protocol interim analysis of the phase III TIGER trial, presented at the 2019 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 495), treatment with nilotinib plus pegylated interferon α2b (Peg-IFN) may be a feasible first-line option for patients with chronic myeloid leukemia (CML). According to Andreas Hochhaus, MD, of the Universitätsklinikum Jena, Germany, and colleagues, “Peg-IFN, when added upfront to [nilotinib], further increases the rates of [molecular response 4] and [molecular response 4.5], which may translate into higher rates of treatment-free remission.”

In this trial, the authors enrolled 692 patients with CML from 109 sites in Germany, Switzerland, and the Czech Republic. Patients received 300 mg of nilotinib twice daily (353 patients) or 300 mg of nilotinib twice daily plus Peg-IFN (339 patients).

After a median observation time of 41 months, 477 patients finished the induction phase by achieving a confirmed molecular response. During the maintenance phase, 199 patients achieved or sustained molecular response 4 for at least 1 year and then discontinued all therapy.

The authors found that the rate of major molecular response at 12 and 18 months was the same for both treatment groups, whereas adding Peg-IFN to upfront nilotinib “significantly improved” the rates of molecular response 4 and molecular response 4.5. Following nilotinib discontinuation, during Peg-IFN maintenance therapy, the rate of molecular recurrence among patients was 28% after 18 months. The relapse-free survival rate for all patients 18 months after treatment discontinuation was 61%.

For patients treated with nilotinib monotherapy, 90% experienced any-grade adverse events, and 36% experienced grades 3 through 5 adverse events after 24 months of therapy. For those treated with Peg-IFN, 92% reported any-grade adverse events, and 42% reported grades 3 through 5 adverse events.

Disclosure: For full disclosures of the study authors, visit ashpublications.org.



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