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Reblozyl May Be 'The Standard Of Care' Now In Lower-Risk MDS, Anemia
An expert discussed the findings of the COMMANDS trial evaluating Reblozyl's role in red blood cell transfusion independence for patients with MDS.
Patients with lower-risk MDS and anemia may benefit from Reblozyl as standard of care.
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Reblozyl (luspatercept) has become the new standard of care for patients with low-risk myelodysplastic syndromes (MDS) facing anemia (low red blood cell count), an expert explained in an interview with CURE®.
Dr. Guillermo Garcia-Manero of the Department of Leukemia, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center in Houston, led the phase 3 COMMANDS study comparing treatment with Reblozyl with treatment via epoetin alfa, a type of drug known as an erythropoiesis-stimulating agent (ESA), which stimulates the bone marrow to produce more red blood cells.
"In this study, it is very clear that this agent [Reblozyl] is superior to a standard of care in terms of improvement of [blood] transfusion needs, increasing levels of hemoglobin for a significant fraction of patients with MDS," Garcia-Manero said during an interview with CURE®. "So, basically, in my opinion, this is now the standard of care for a large majority of patients with anemia [and] lower-risk MDS."
The Food and Drug Administration (FDA) approved Reblozyl in 2020 for the treatment of patients with MDS who required red blood cell transfusions and had received treatment with an ESA. That approval was expanded by the FDA in 2023, based on the findings of the COMMANDS trial, to include the treatment of anemia in patients with very low- to intermediate-risk MDS who may require red blood cell transfusions and had not received an ESA.
LEARN MORE: Reblozyl Continues to Improve MDS Transfusion Independence
MDS encompasses many bone marrow disorders that involve the bone marrow not producing enough healthy blood cells, according to the MDS Foundation, which states on its website that most people are anemic when they receive an initial diagnosis of MDS. Signs and symptoms of anemia include fatigue, heart palpitations, shortness of breath and pale skin. Reblozyl, according to the National Cancer Institute, is intended to enhance the bone marrow's red blood cell production.
COMMANDS enrolled 363 patients with MDS of very low risk, low risk or intermediate risk who had not been treated with ESAs and were, due to anemia, dependent on blood transfusions and treated with Reblozyl (182 patients) or epoetin alfa (181 patients).
The study's primary goals included at least 12 weeks of red blood cell transfusion independence and a mean hemoglobin increase of at least 1.5 grams per deciliter in weeks 1 to 24 that was met by 60% of the Reblozyl group and 35% of the epoetin alfa group at median follow-ups of 17.2 months and 16.9 months, respectively.
At a median follow-up of 21.4 months in the Reblozyl group and 20.3 months in the epoetin alfa group, common grade 3 (severe) or 4 (life-threatening) treatment-emergent side effects that occurred among patients treated with Reblozyl (182 patients) were hypertension (19 patients), anemia (18 patients), pneumonia (10 patients), syncope (fainting; 10 patients), neutropenia (low count of neutrophils, a type of white blood cell; nine patients), thrombocytopenia (low platelet count; eight patients) and dyspnea (shortness of breath; eight patients) and MDS (six patients).
For the 179 recipients of epoetin alfa, common grade 3/4 treatment-emergent side effects included anemia (14 patients), pneumonia (14 patients), neutropenia (11 patients), MDS (10 patients), hypertension (eight patients), iron overload (seven patients) and COVID-19 pneumonia (six patients).
Researchers reported that the most common serious treatment-emergent side effects in both groups were pneumonia (nine in the Reblozyl group and 13 in the epoetin alfa group) and COVID-19 (eight and 10 patients, respectively), and one death, due to acute myeloid leukemia, was considered to be Reblozyl-related and reported at the time of the interim data analysis.
The findings of COMMANDS, Garcia-Manero said, have in turn led to the ELEMENTS-MDS trial evaluating Reblozyl among transfusion-independent patients with MDS with anemia. That phase 3 study, according to its listing on clinicaltrils.Gov, is currently recruiting patients.
"Based on the [established] safety profile and the level of activity, we're moving into a large study looking at this drug [as] front[line treatment] in transfusion-independent patients with anemia," he said. "That is actually where we think that these drugs will really, really work well, actually, when you have significant activity."
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Why Transfusion Independence Matters For Patients With MDS
An expert explained the burden that red blood cell transfusions can place on patients with MDS.
Among patients with myelodysplastic syndromes (MDS), treatment with Reblozyl (luspatercept) resulted in at least 12 weeks of blood transfusion independence as well as a significant increase in hemoglobin, researchers have reported.
The phase 3 COMMANDS study enrolled 363 adult patients with MDS of very low risk, low risk or intermediate risk who had not been treated with erythropoiesis-stimulating agents (ESAs, medications that stimulate bone marrow to make more red blood cells) and were dependent on blood transfusions due to anemia and allocated them to treatment via Reblozyl (182 patients) or epoetin alfa (181 patients).
The study's primary endpoint of red blood cell transfusion independence lasting at least 12 weeks and a mean hemoglobin increase of at least 1.5 grams per deciliter in weeks 1 to 24 was met by 60% of the Reblozyl group and 35% of the epoetin alfa group at median follow-ups of 17.2 months and 16.9 months, respectively.
According to the Leukemia and Lymphoma Society, 60% to 80% of patients with MDS will have anemia, or a low red blood cell count, at the time of their diagnosis, and up to 90% of patients will need at least one transfusion during their illness. Red blood cell transfusions, the organization explains on its website, can improve blood cell counts or improve anemia symptoms including shortness of breath, dizziness, extreme fatigue and chest pain.
"[Reblozyl] represents a new standard of care for ESA-naive patients with transfusion-dependent, lower-risk myelodysplastic syndromes," researchers wrote in a study presenting their findings in The Lancet Hematology."Significantly more patients had red blood cell transfusion independence and hematological improvement with [Reblozyl] than with epoetin alfa, with benefits observed across patient subgroups."
Study co-author Dr. Guillermo Garcia-Manero of the Department of Leukemia, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center in Houston, spoke with CURE® about the burden of red blood cell transfusion dependence, and why transfusion independence is such an important potential outcome for patients.
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First of all, from a pharmacoeconomic perspective, these transfusions actually are not free, No. 1. Second, you have to sit in a chair for a few hours getting these units of blood, sometimes they are associated with a little bit of reaction. Sometimes they can, rarely, but they can be severe. You have to be pre-medicated for these transfusions, so some people may need some steroids, some Tylenol, some Benadryl so they can tolerate this. Before you get these transfusions, you need to have special lab work, where they type and cross or type and match you so they find the unit. So you're waiting, actually, for a little bit of time to find these units. You know, in place like MD Anderson, this can happen in the same day, or it always happens in the same day. But in some places that are not as dense or you are in a rural population, sometimes those products come one to two days after you are found to be in need of the transfusion.
So just the mechanics around these transfusions are actually quite significant. The cost is not insignificant. And for the patient, again, it means that you are sitting in a chair for a few hours when you get that. Basically, your day is gone, and you may not feel 100% well when getting them, after that. They're lifesaving. And if you feel better, your hemoglobin hopefully goes up. But with time, these transfusions actually, particularly in patients that need chronic transfusions and there are people actually that need them, sometimes once a week, sometimes more than once a week. Eventually, your body creates antibodies against them, and you start not responding as well as you were. So let's say, if you get a unit of blood and hemoglobin goes [up] one gram or two, then OK, you're OK for a little bit of time, but then eventually these responses are not that meaningful. So they are expensive. They are very safe in the United States, but still, you may have some little complication from them. Occasionally, this could be severe, and it's a major time commitment for patients, so not something that anybody would like to have.
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HMA Persistence And Effectiveness In Higher Risk MDS
Medical experts offer insights on the persistence and effectiveness of HMAs in patients with higher-risk MDS.
Video content above is prompted by the following:
What insights do you have on the persistence and effectiveness of hypomethylating agents in patients with higher-risk myelodysplastic syndromes, and how do these data inform treatment decisions?
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