Patients with myelodysplastic syndrome (MDS) tended to have longer intervals of time when they were not reliant on red blood cell infusions when treated with Reblozyl (luspatercept) compared to epoetin alfa, according to findings from the phase 3 COMMANDS trial presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
MDS is a disease that occurs when the bone marrow does not make enough healthy blood cells. As such, patients may rely on transfusions to manage anemia, which is a decrease in red blood cells.
Study Highlights:
- Reblozyl, which was approved last summer, led to more patients with myelodysplastic syndromes achieving 12- and 24-week intervals of red blood cell transfusion independence compared with epoetin alfa.
- Patients treated with Reblozyl also needed fewer units of blood during transfusions.
- More patients in the Reblozyl group cut the number of times they had to undergo red blood cell transfusions in half.
- Reblozyl treatment led to more patients having multiple 12-plus-week periods of transfusion independence.
“Overall, [Reblozyl] led to durable and clinically meaningful responses beyond the achievement of the primary endpoint, supporting its use of choice over [erythropoiesis (red blood cell)-stimulating agents] in patients with [transfusion-dependent low-risk] MDS-associated anemia who are [erythropoiesis-stimulating agents]-naive,” the study authors wrote in a poster presented in the meeting.
Notably, data from the COMMANDS trial supported the August 2023 FDA approval of Reblozyl in this setting. Findings showed that Reblozyl led to red blood cell transfusion independence in 47.6% of patients.
COMMANDS included patients with very low-, low- or intermediate-risk MDS that required red blood cell transfusions and have not previously been treated with erythropoiesis-stimulating agents, which are drugs like epoetin alfa given to stimulate red blood cell production.
Patients were randomly assigned to receive either Reblozyl (182 patients) or epoetin alfa (181 patients).
12- and 24-Week Transfusion Independence Rates
Now, data from COMMANDS presented at ASCO showed that from 70.9% of patients in the Reblozyl group achieved transfusion independence (no longer requiring blood transfusions) of 12 weeks or longer, with a prespecified simultaneous average hemoglobin increase. In the epoetin alfa group, this was achieved by 43.1% of patients. Of note, the median longest duration until end of treatment was 128.1 weeks in the Reblozyl group and 95.1 weeks in the epoetin alfa group.
Twelve-week or longer transfusion independence, regardless of hemoglobin increase was achieved in 76.4% and 55.8% of patients in the Reblozyl and epoetin alfa groups, respectively. The median longest duration until the end of treatment was 126.6 and 75.6 weeks, respectively.
Further, response rates of transfusion independence of 24 weeks or longer were achieved in 65.9% of patients in the Reblozyl group, compared to 45.3% in the epoetin alfa group.
Erythroid hematologic improvement, which is defined as an improvement in erythrocytes (a type of red blood cell) was observed in 80.2% and 57.5% of patients, respectively. Additionally, more patients in the Reblozyl group had an increase in hemoglobin levels deemed significant by the researchers compared to those in the epoetin alfa group.
“The median increase in hemoglobin level with [Reblozyl] was rapid and sustained throughout the entire treatment period,” the researchers wrote.
Achievement of 50% or More Transfusion Reduction
The researchers also analyzed percentage of patients who achieved a 50% or more reduction in the amount of red blood cell units received over the course of 12 weeks. This was achieved in 83% in the Reblozyl group and 66.9% in the epoetin alfa group.
“Higher rates of 50% or more [red blood cell] transfusion burden reduction were observed with [Reblozyl], regardless of baseline transfusion burden,” the authors wrote.
More specifically, in patients who required less than four units of red blood cell per eight weeks, the 50% or more reduction in units transfused was 89% and 73.9% in the Reblozyl and epoetin alfa groups, respectively. For patients who required four or more units every eight weeks, the rates were 71.9% and 55.7%, respectively.
Number of 12-Week Periods Without Transfusions Required
Throughout the duration of the study, 28 of the 139 (20.1%) patients receiving Reblozyl who experienced transfusion independence of 12 weeks or longer had two or more response episodes of at least 12 weeks. This is compared to 17 of 101 (16.8%) in the epoetin alfa arm.
When researchers added together the entire duration of all responses, it was 154.7 weeks in the Reblozyl group, compared to 91.1 weeks in the epoetin alfa group.
“A greater proportion of patients treated with [Reblozyl] than with epoetin alfa achieved two or more separate [red blood cell transfusion-independent] 12-week response episodes with [approximately] 1.7 times longer median cumulative duration,” the authors wrote.
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