ASH 2019: Nilotinib Plus Pegylated IFN Alpha 2a Therapy for Chronic Phase CML
Posted: Tuesday, December 24, 2019
According to the phase III PETALS trial, presented at the 2019 American Society of Hematology (ASH) Annual Meeting & Exposition in Orlando, Florida (Abstract 495), nilotinib plus pegylated interferon IFN alpha 2a seems to induce somewhat higher rates of deep molecular responses in patients with chronic phase chronic myeloid leukemia (CML) than nilotinib alone. However, Franck E. Nicolini, MD, PhD, of Centre Léon Bérard, Lyon, France, and colleagues are still evaluating whether this combination will translate to higher rates of treatment-free remission.
The research team randomly assigned 200 patients with newly diagnosed chronic phase CML to receive nilotinib (n = 99) or nilotinib plus pegylated IFN alpha 2a (n = 101). The investigators evaluated the molecular responses and toxicity profiles of both treatment groups.
At month 12, the rates of major molecular responses were 68.1% and 70.1% in the monotherapy and combination-therapy arms, respectively. Deep molecular responses were somewhat higher in the combination therapy arm (34% vs. 47.5%; P = .041). Similarly, fewer patients in the nilotinib monotherapy arm achieved a deep molecular remission (MR4.5) than in the nilotinib plus pegylated IFN alpha 2a arm (15.9% vs. 21.5%; P = .049). At 36 months after treatment initiation, the cumulative incidence of MR4.5 was also higher in the combination-therapy arm than in the nilotinib-alone arm (54.6% vs. 44%; P = .05).
The toxicity profiles were similar between the two treatment groups. A single patient died of cervical cancer in the monotherapy arm. Notably, psychiatric episodes occurred in 8% of patients who received combination therapy (including suicide attempts) versus 2% who received monotherapy.
Disclosure: For full disclosures of the study authors, visit ash.confex.com.