Secondary endpoint: Median duration of RBC-TI ≥12 weeks (Week 1-EOT)
Duration of RBC-TI for ≥12 weeks2
Analysis limitations: Duration of RBC-TI ≥12 weeks was not powered to detect statistical
significance.1
Data cutoff date: August 2022.
From the full analysis 48-week follow-up
REBLOZYL results across key subgroups2
Response rates of the preplanned subgroup analysis of RBC-TI for ≥24 weeks (Weeks 1-48)2
Analysis limitations:
-
Subgroup analyses were performed for the primary and key secondary efficacy endpoints. Formal
hypothesis testing was not performed
-
These analyses should not be interpreted to determine treatment differences between arms in
these subgroups because of limited sample size, lack of statistical hypothesis testing, and the
increased probability of a false-positive finding
P<0.0001.
Data cutoff date: September 2023.
From the full analysis
Nearly 80% of patients in COMMANDS had baseline sEPO ≤200 U/L2†
Among patients with baseline sEPO ≤200 U/L
RBC-TI for ≥12 weeks and mean Hgb increase ≥1.5 g/dL3
Duration of RBC-TI for ≥12 weeks2
On REBLOZYL, ~38% of EPO >200 patients achieved a mean Hgb increase of ≥1.5 g/dL and TI for ≥12 weeks vs
~11% of patients on epoetin alfa. REBLOZYL patients also achieved a mean of 1 year of TI compared to
patients on epoetin alfa who only experienced a mean of 0.5 years of TI.2,3
The primary endpoint for Weeks 1-24, RBC-TI ≥12 weeks with concurrent mean Hgb increase ≥1.5 g/dL, was
achieved by 86 (58.5%) patients in the REBLOZYL arm versus 48 (31.2%) patients in the epoetin alfa arm
(P<0.0001).4
Analysis limitations:
-
Subgroup analyses were performed for the primary and key secondary efficacy endpoints. Formal
hypothesis testing was not performed
-
These analyses should not be interpreted to determine treatment differences due to limited
sample size, lack of statistical hypothesis testing, and increased probability of a
false-positive finding
145 patients in the REBLOZYL arm and 144 patients in the epoetin alfa arm had sEPO ≤200 U/L.2
Data cutoff date: March 2023.
From the full analysis 48-week follow-up‡
COMMANDS had 99 RS- patients, the most of any Phase 3, LR-MDS study3,5,6
Among RS- patients
RBC-TI for ≥12 weeks and mean Hgb increase ≥1.5 g/dL3
Duration of RBC-TI for ≥12 weeks2
The primary endpoint for Weeks 1-24, RBC-TI ≥12 weeks with concurrent mean Hgb increase ≥1.5 g/dL, was
achieved by 86 (58.5%) patients in the REBLOZYL arm versus 48 (31.2%) patients in the epoetin alfa arm
(P<0.0001).4
Analysis limitations:
-
Subgroup analyses were performed for the primary and key secondary efficacy endpoints. Formal
hypothesis testing was not performed
-
These analyses should not be interpreted to determine treatment differences due to limited
sample size, lack of statistical hypothesis testing, and increased probability of a
false-positive finding
Exploratory endpoint.
Data cutoff date: September 2023.
Using sEPO ≤200 as a parameter in the LR-MDS treatment algorithm
George Yaghmour, MD
USC Norris Comprehensive Cancer Center & Hospital
Los Angeles, CA
Clinical response and duration in the RS- subgroups
Jamie Koprivnikar, MD
John Theurer Cancer Center Hackensack University Medical Center
Hackensack, NJ