Bristol Myers Squibb Announces Positive Topline Results of Phase 3 COMMANDS Trial
eblozyl, the first erythroid development agent, met primary and crucial secondary endpoints in the first- line treatment of cases with veritably low low/ intermediate- threat myelodysplastic runs
PRINCETON,N.J.–( BUSINESS WIRE)– Bristol Myers Squibb( NYSE BMY) moment blazoned the COMMANDS study, a Phase 3, open- marker, randomized trial assessing Reblozyl ®( luspatercept- aamt), met its primary endpoint, demonstrating a largely statistically significant and clinically meaningful enhancement in red blood cell transfusion independence( RBC- TI) with concurrent hemoglobin( Hb) increase in the first- line treatment of adult cases with veritably low-, low- or intermediate- threat myelodysplastic runs( MDS) who bear RBC transfusions. This result was grounded on apre-specified interim analysis conducted through an independent review commission. Safety results in the trial were harmonious with the safety profile of Reblozyl preliminarily demonstrated in the MEDALIST study( NCT02631070), and no new safety signals were reported.
“ While advancements have been made in the treatment of anemia for cases with myelodysplastic runs, there remains a significant need for new and better first- line treatment options for cases with transfusion-dependent MDS, ” said Noah Berkowitz,M.D.,Ph.D., elderly vice chairman, Hematology Development, Bristol Myers Squibb. “ We’re pleased with the positive results of the COMMANDS study and look forward to presenting these important data. ”
Bristol Myers Squibb will complete a full evaluation of the COMMANDS data and work with investigators to present detailed results at an forthcoming medical meeting, as well as bandy these results with health authorities. Bristol Myers Squibb thanks the cases and investigators who are sharing in the COMMANDS clinical trial.
Reblozyl is being developed and capitalized through a global collaboration with Merck following Merck’s accession of Acceleron Pharma,Inc. in November 2021.
About COMMANDS
COMMANDS( NCT03682536) is a Phase 3, open- marker, randomized study assessing the efficacity and safety of Reblozyl versus epoetin alfa, for the treatment of anemia due to veritably low-, low- or intermediate- threat( IPSS- R) myelodysplastic pattern( MDS) in cases who are red blood cell( RBC) transfusion dependent and were erythropoiesis stimulating agent( ESA) naïve.
The primary endpoint estimated in this study is RBC transfusion independence( RBC- TI) for 12 weeks with a mean hemoglobin increase ≥1.5 g/ dL. crucial secondary endpoints include RBC- TI for 24 weeks, RBC- TI ≥ 12 weeks and erythroid response of at least 8 weeks during weeks 1- 24 of the study.
About Myelodysplastic Runs
Myelodysplastic runs( MDS) are a group of nearly affiliated blood cancers characterized by ineffective product of healthy red blood cells, white blood cells and platelets, which can lead to anemia and frequent or severe infections.1, 2 People with MDS who develop anemia frequently bear regular blood transfusions to increase the number of healthy red blood cells in rotation.3 Frequent transfusions are associated with an increased threat of iron load, transfusion responses and infections.4
About Reblozyl ®( luspatercept- aamt)
Reblozyl, a first- in- class remedial option, promotes late- stage red blood cell development in beast models.5 Reblozyl is being developed and capitalized through a global collaboration with Merck following Merck’s accession of Acceleron Pharma,Inc. in November 2021. Reblozyl is presently approved in theU.S. for the treatment of
anemia in adult cases with beta thalassemia who bear regular red blood cell transfusions, and
anemia failing an erythropoiesis stimulating agent and taking 2 or further red blood cell units over 8 weeks in adult cases with veritably low- to intermediate- threat myelodysplastic pattern with ring sideroblasts( MDS- RS) or with myelodysplastic/ myeloproliferative lump with ring sideroblasts and thrombocytosis( MDS/ MPN- RS- T).
Reblozyl isn’t indicated for use as a cover for red blood cell transfusions in cases who bear immediate correction of anemia.
Beta Thalassemia
Serious adverse Responses passed in3.6 of cases on REBLOZYL. Serious adverse responses being in 1 of cases included cerebrovascular accident and deep tone thrombosis. A fatal adverse response passed in 1 case treated with REBLOZYL who failed due to an unconfirmed case of acute myeloid leukemia( AML).
Most common adverse responses( at least 10 for REBLOZYL and 1 further than placebo) were headache( 26 vs 24), bone pain( 20 vs 8), arthralgia( 19 vs 12), fatigue( 14 vs 13), cough( 14 vs 11), abdominal pain( 14 vs 12), diarrhea( 12 vs 10) and dizziness( 11 vs 5).
Myelodysplastic Runs
Grade ≥ 3( ≥ 2) adverse responses included fatigue, hypertension, blackout and musculoskeletal pain. A fatal adverse response passed in 5(2.1) cases.
The most common( ≥ 10) adverse responses included fatigue, musculoskeletal pain, dizziness, diarrhea, nausea, acuity responses, hypertension, headache, upper respiratory tract infection, bronchitis, and urinary tract infection.
Bristol Myers Squibb Creating a More unborn for People with Cancer
Bristol Myers Squibb is inspired by a single vision — transubstantiating people’s lives through wisdom. The thing of the company’s cancer exploration is to deliver drugs that offer each case a better, healthier life and to make cure a possibility. structure on a heritage across a broad range of cancers that have changed survival prospects for numerous, Bristol Myers Squibb experimenters are exploring new borders in individualized drug, and through innovative digital platforms, are turning data into perceptivity that edge their focus. Deep scientific moxie, slice- edge capabilities and discovery platforms enable the company to look at cancer from every angle. Cancer can have a grim grasp on numerous corridor of a case’s life, and Bristol Myers Squibb is committed to taking conduct to address all aspects of care, from opinion to survivorship. Because as a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose charge is to discover, develop and deliver innovative drugs that help cases prevail over seriousdiseases.
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