James K. McCloskey, MD, discusses the utility of decitabine plus cedazuridine in lower-risk myelodysplastic syndromes, based on data from the long-term follow-up of the phase 3 ASCERTAIN trial.
James K. McCloskey, MD, chief, Leukemia Division, John Theurer Cancer Center, Hackensack Meridian Health, discusses the utility of decitabine plus cedazuridine (Inqovi) in lower-risk myelodysplastic syndromes (MDS), based on data from the long-term follow-up of the phase 3 ASCERTAIN trial (NCT03306264).
Toxicities seen in this study with decitabine/cedazuridine were expected based on prior knowledge of hypomethylating agents, as well as previous published data from the ASCERTAIN trial, McCloskey says. These previous safety data showed that common toxicities observed with the regimen included cytopenia, infectious complications like febrile neutropenia, and pneumonia, McCloskey adds.
Moreover, the long-term follow-up data demonstrated an overall response rate of 56.5% with the combination, which included a complete response rate of 23.2%, McCloskey continues. The rate of transfusion independence was notable in this dataset, which is an important achievement in patients with low-risk MDS, McCloskey says. Of those evaluable, 48.1% of patients receiving red cell transfusions at study entry became transfusion independent at 56 days, and 66.7% of patients receiving platelet transfusions at study entry became platelet and transfusion independent at 56 days with the addition of decitabine and cedazuridine. The rates of transfusion independence at 84 days were 40.7% and 33.3%, respectively, McCloskey concluded.