Dr. Garcia-Manero on the Data Behind the Luspatercept Approval

Guillermo Garcia–Manero, MD, of the University of Texas MD Anderson Cancer Center, joins Chadi Nabhan, MD, MBA, FACP, live at the Eleventh Annual Meeting of the Society of Hematologic Oncology to discuss the phase III COMMANDS trial, the recent approval of luspatercept, and other developments in myelodysplastic syndromes (MDS) treatment and research.

Dr. Garcia-Manero spoke about the design of the phase III COMMANDS trial, which evaluated luspatercept versus epoetin alfa for the treatment of anemia in patients with lower-risk MDS who required red blood cell (RBC) transfusions but had not previously received an erythropoiesis-stimulating agent.

“The study is very interesting in that it’s very well controlled … and the data [are] very clear,” he said.

The phase III trial showed 58.5% of patients receiving luspatercept achieved the primary endpoint of RBC transfusion independence for at least 12 weeks with a mean hemoglobin increase of at least 1.5 g/dL within the first 24 weeks, while this was only reported in 31.2% of patients receiving epoetin alfa.

Dr. Garcia-Manero highlighted what he sees as other key findings from the trial.

“The duration of response was significantly longer—actually a year longer—with luspatercept versus the [erythropoiesis-stimulating agents] and that was not part of the primary endpoint, but for me as a practicing physician, if you have a high rate of response and that response actually is maintained for a long period of time, it’s very meaningful,” he said.

The recent US Food and Drug Administration approval of luspatercept for the treatment of anemia without previous ESA use in adults with very low- to intermediate-risk MDS who may require regular red blood cell transfusions was based on interim results from the pivotal phase III COMMANDS trial.