Dr Komrokji on Ongoing Studies in Higher- and Lower-Risk MDS

Rami Komrokji, MD, vice chair, Malignant Hematology Department, head, the Leukemia and MDS Section, Moffitt Cancer Center, senior member, the Malignant Hematology and Experimental Therapeutics Program, professor in Medicine & Oncologic Sciences, the College of Medicine, the University of South Florida, discusses ongoing clinical trials in patients with higher- and lower-risk myelodysplastic syndromes (MDS).

Updated classifications designed to distinguish molecular subgroups within MDS and new risk stratifications that incorporate these molecular subcategories have helped advance the MDS treatment landscape, Komrokji notes.

In terms of treatment options, the landscape for lower-risk MDS is also continuing to change, he continues. For example, at the 2023 ASCO Annual Meeting, investigators presented data from the phase 3 COMMANDS trial (NCT03682536) evaluating the efficacy and safety of luspatercept-aamt (Reblozyl) vs erythropoiesis-stimulating agents (ESAs) for the treatment of anemia in patients with very low–, low-, or intermediate-risk MDS who had not received prior treatment with an ESA.

The study met its primary end point for red blood cell transfusion independence, and the agent is currently under priority review by the FDA for the treatment of anemia in patients with very low– to intermediate-risk MDS who have not previously received ESAs and who may require RBC transfusions. COMMANDS has the potential to shift the treatment landscape and move luspatercept into the earlier settings as an additional treatment option, Komrokji expands.

In higher-risk MDS, transplants are becoming more commonplace, Komrokji explains. There are also several ongoing phase 3 trials within this patient population, and results may potentially change the current standard-of-care, which has been hypomethylating agents, he adds.

The phase 3 VERONA trial (NCT04401748) is comparing venetoclax (Venclexta) plus azacitidine (Vidaza) vs azacitidine alone. Additionally, the phase 3 ENHANCE study (NCT04313881) is evaluated magrolimab with azacitidine vs azacitidine with placebo.