Pictured: White and pink BMS logo on blue and white building/hapabapa/iStock
Initial results from the Phase III COMMANDS study show Bristol Myers Squibb’s Reblozyl (luspatercept-aamt) could be a promising first-line treatment option for anemia in patients with lower-risk myelodysplastic syndrome, the company announced Thursday.
These data, which will be presented at the upcoming 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, show that 58.5% of participants treated with Reblozyl achieved red blood cell transfusion independence (RBC-TI), defined as being able to go for at least 12 weeks without needing transfusion, coupled with an average hemoglobin increase of at least 1.5 g/dL.
In comparison, patients who were treated with Amgen’s Epogen (epoetin alfa) or Janssen’s Procrit (epoetin alfa) only saw nearly half the RBC-TI rate, at 31.2%. The difference between treatment arms was highly statistically significant, according to BMS.
Currently, the standard first-line care for lower-risk myelodysplastic syndromes (MDS) involves erythropoiesis-stimulating agents (ESA), such as epoetin alfa, Guillermo Garcia-Manero, lead author of COMMANDS, said in an ASCO news release.
“Luspatercept could potentially alter this treatment landscape such that patients could receive luspatercept first instead of ESAs,” Garcia-Manero said. “Patients will need to visit the clinic less often and receive blood transfusions less frequently. They will benefit from improved quality of life and better outcomes.”
COMMANDS enrolled more than 350 lower-risk adult MDS patients who were in need of red blood cell transfusions for anemia, but had not yet been treated with ESAs. Reblozyl injections were administered once every three weeks, while the ESA comparator was given at weekly doses.
As for safety, COMMANDS found a slightly higher rate of treatment-emergent and treatment-related adverse events in the Rebolzyl group than in the control arm. Eight Reblozyl-treated patients withdrew due to toxicities, while four did so among epoetin alfa comparators.
Rates of death and progression to acute myeloid leukemia were comparable between study arms.
BMS will also present these findings at the upcoming European Hematology Association (EHA) Congress. Additionally, the company will present data showing that Reblozyl’s clinical benefit remains across different MDS mutations and regardless of overall mutational burden.
These data could help BMS build its case to push Reblozyl into the frontline setting for MDS. The erythroid maturation agent is currently approved to treat anemia in MDS patients who had previously failed an ESA and who need at least two red blood cell units over an eight-week period.
BMS has filed a supplemental Biologics License Application with the FDA, which the regulator accepted earlier this month, seeking to expand Reblozyl’s label to cover ESA-naïve patients with very low- to intermediate-risk MDS. The application has been granted Priority Review and is set to receive a decision by August 28.
Tristan Manalac is an independent science writer based in metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
