Reblozyl, the first erythroid maturation agent, met primary and key secondary endpoints in the first-line treatment of patients with very low/low/intermediate-risk myelodysplastic syndromes
PRINCETON, NJ, USA I October 31, 2022 I Bristol Myers Squibb (NYSE: BMY) today announced the COMMANDS study, a Phase 3, open-label, randomized trial evaluating Reblozyl®(luspatercept-aamt), met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful improvement in red blood cell transfusion independence (RBC-TI) with concurrent hemoglobin (Hb) increase in the first-line treatment of adult patients with very low-, low- or intermediate-risk myelodysplastic syndromes (MDS) who require RBC transfusions. This result was based on a pre-specified interim analysis conducted through an independent review committee. Safety results in the trial were consistent with the safety profile of Reblozyl previously demonstrated in the MEDALIST study (NCT02631070), and no new safety signals were reported.
“While advancements have been made in the treatment of anemia for patients with myelodysplastic syndromes, there remains a significant need for new and better first-line treatment options for patients with transfusion-dependent MDS,” said Noah Berkowitz, M.D., Ph.D., senior vice president, Hematology Development, Bristol Myers Squibb. “We are 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 upcoming medical meeting, as well as discuss these results with health authorities. Bristol Myers Squibb thanks the patients and investigators who are participating in the COMMANDS clinical trial.
Reblozyl is being developed and commercialized through a global collaboration with Merck following Merck’s acquisition of Acceleron Pharma, Inc. in November 2021.
About COMMANDS
COMMANDS (NCT03682536) is a Phase 3, open-label, randomized study evaluating the efficacy and safety of Reblozyl versus epoetin alfa, for the treatment of anemia due to very low-, low- or intermediate-risk (IPSS-R) myelodysplastic syndrome (MDS) in patients who are red blood cell (RBC) transfusion dependent and were erythropoiesis stimulating agent (ESA) naïve.
The primary endpoint evaluated in this study is RBC transfusion independence (RBC-TI) for 12 weeks with a mean hemoglobin increase ≥1.5 g/dL. Key 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 Syndromes
Myelodysplastic syndromes (MDS) are a group of closely related blood cancers characterized by ineffective production 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 often require regular blood transfusions to increase the number of healthy red blood cells in circulation.3 Frequent transfusions are associated with an increased risk of iron overload, transfusion reactions and infections.4
About Reblozyl® (luspatercept-aamt)
Reblozyl, a first-in-class therapeutic option, promotes late-stage red blood cell maturation in animal models.5 Reblozyl is being developed and commercialized through a global collaboration with Merck following Merck’s acquisition of Acceleron Pharma, Inc. in November 2021. Reblozyl is currently approved in the U.S. for the treatment of:
- anemia in adult patients with beta thalassemia who require regular red blood cell transfusions, and
- anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndrome with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).
Reblozyl is not indicated for use as a substitute for red blood cell transfusions in patients who require immediate correction of anemia.
Please see full Prescribing Information for REBLOZYL.
Bristol Myers Squibb: Creating a Better Future for People with Cancer
Bristol Myers Squibb is inspired by a single vision — transforming people’s lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine, and through innovative digital platforms, are turning data into insights that sharpen their focus. Deep scientific expertise, cutting-edge capabilities and discovery platforms enable the company to look at cancer from every angle. Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis 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 mission is to discover, develop and deliver innovative medicines that help patients prevail over seriousdiseases. For more information about Bristol Myers Squibb,visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.
References:
- Mount Sinai. Myelodysplastic Syndrome. Available at: https://www.mountsinai.org/care/cancer/services/mds. Accessed September 2022.
- Myelodysplastic Syndromes Foundation. What is MDS? Available at: https://www.cancer.org/cancer/myelodysplastic-syndrome/about/what-is-mds.html. Accessed September 2022.
- Johns Hopkins Medicine. Myelodysplastic Syndrome. Available at: https://www.hopkinsmedicine.org/kimmel_cancer_center/types_cancer/myelodysplastic_syndrome.html. Accessed September 2022.
- Rasel M, Mahboobi SK. Transfusion Iron Overload. PubMed. 2021. Available at: https://www.ncbi.nlm.nih.gov/books/NBK562146/. Accessed September 2022.
- Galanello R, Origa R. Beta thalassemia. Orphanet Journal of Rare Diseases. 2010;5(11). Available at: https://ojrd.biomedcentral.com/articles/10.1186/1750-1172-5-11. Accessed September 2022.
SOURCE: Bristol Myers Squibb
Post Views: 82
Reblozyl, the first erythroid maturation agent, met primary and key secondary endpoints in the first-line treatment of patients with very low/low/intermediate-risk myelodysplastic syndromes
PRINCETON, NJ, USA I October 31, 2022 I Bristol Myers Squibb (NYSE: BMY) today announced the COMMANDS study, a Phase 3, open-label, randomized trial evaluating Reblozyl®(luspatercept-aamt), met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful improvement in red blood cell transfusion independence (RBC-TI) with concurrent hemoglobin (Hb) increase in the first-line treatment of adult patients with very low-, low- or intermediate-risk myelodysplastic syndromes (MDS) who require RBC transfusions. This result was based on a pre-specified interim analysis conducted through an independent review committee. Safety results in the trial were consistent with the safety profile of Reblozyl previously demonstrated in the MEDALIST study (NCT02631070), and no new safety signals were reported.
“While advancements have been made in the treatment of anemia for patients with myelodysplastic syndromes, there remains a significant need for new and better first-line treatment options for patients with transfusion-dependent MDS,” said Noah Berkowitz, M.D., Ph.D., senior vice president, Hematology Development, Bristol Myers Squibb. “We are 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 upcoming medical meeting, as well as discuss these results with health authorities. Bristol Myers Squibb thanks the patients and investigators who are participating in the COMMANDS clinical trial.
Reblozyl is being developed and commercialized through a global collaboration with Merck following Merck’s acquisition of Acceleron Pharma, Inc. in November 2021.
About COMMANDS
COMMANDS (NCT03682536) is a Phase 3, open-label, randomized study evaluating the efficacy and safety of Reblozyl versus epoetin alfa, for the treatment of anemia due to very low-, low- or intermediate-risk (IPSS-R) myelodysplastic syndrome (MDS) in patients who are red blood cell (RBC) transfusion dependent and were erythropoiesis stimulating agent (ESA) naïve.
The primary endpoint evaluated in this study is RBC transfusion independence (RBC-TI) for 12 weeks with a mean hemoglobin increase ≥1.5 g/dL. Key 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 Syndromes
Myelodysplastic syndromes (MDS) are a group of closely related blood cancers characterized by ineffective production 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 often require regular blood transfusions to increase the number of healthy red blood cells in circulation.3 Frequent transfusions are associated with an increased risk of iron overload, transfusion reactions and infections.4
About Reblozyl® (luspatercept-aamt)
Reblozyl, a first-in-class therapeutic option, promotes late-stage red blood cell maturation in animal models.5 Reblozyl is being developed and commercialized through a global collaboration with Merck following Merck’s acquisition of Acceleron Pharma, Inc. in November 2021. Reblozyl is currently approved in the U.S. for the treatment of:
- anemia in adult patients with beta thalassemia who require regular red blood cell transfusions, and
- anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndrome with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).
Reblozyl is not indicated for use as a substitute for red blood cell transfusions in patients who require immediate correction of anemia.
Please see full Prescribing Information for REBLOZYL.
Bristol Myers Squibb: Creating a Better Future for People with Cancer
Bristol Myers Squibb is inspired by a single vision — transforming people’s lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine, and through innovative digital platforms, are turning data into insights that sharpen their focus. Deep scientific expertise, cutting-edge capabilities and discovery platforms enable the company to look at cancer from every angle. Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis 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 mission is to discover, develop and deliver innovative medicines that help patients prevail over seriousdiseases. For more information about Bristol Myers Squibb,visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.
References:
- Mount Sinai. Myelodysplastic Syndrome. Available at: https://www.mountsinai.org/care/cancer/services/mds. Accessed September 2022.
- Myelodysplastic Syndromes Foundation. What is MDS? Available at: https://www.cancer.org/cancer/myelodysplastic-syndrome/about/what-is-mds.html. Accessed September 2022.
- Johns Hopkins Medicine. Myelodysplastic Syndrome. Available at: https://www.hopkinsmedicine.org/kimmel_cancer_center/types_cancer/myelodysplastic_syndrome.html. Accessed September 2022.
- Rasel M, Mahboobi SK. Transfusion Iron Overload. PubMed. 2021. Available at: https://www.ncbi.nlm.nih.gov/books/NBK562146/. Accessed September 2022.
- Galanello R, Origa R. Beta thalassemia. Orphanet Journal of Rare Diseases. 2010;5(11). Available at: https://ojrd.biomedcentral.com/articles/10.1186/1750-1172-5-11. Accessed September 2022.
SOURCE: Bristol Myers Squibb
Post Views: 82
