Amer Zeidan, MBBS, discusses the recent expansion of the indication for luspatercept-amt to the frontline setting to treat anemia in patients with lower-risk myelodysplastic syndromes.
Amer Zeidan, MBBS, associate professor of internal medicine (Hematology), chief of hematologic malignancies and director of early therapeutics research for Hematology, and leader of the clinical research team for leukemias and myeloid malignancies at the Yale Cancer Center, discusses the data that led to the approval of luspatercept-amt (Reblozyl) to treat anemia in patients with myelodysplastic syndromes (MDS).
The initial approval for luspatercept was for certain adults with MDS who progressed on an erythropoiesis-stimulating agent (ESA) and needed 2 or more red blood cell (RBC) units over 8 weeks. These patients included those patients with very low- to intermediate-risk MDS with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with RS and thrombocytosis. This approval was based off the MEDALIST trial (NCT02631070), which met its primary end point of more patients being RBC-transfusion independent with luspatercept (37.9%) compared with those on placebo (24.6%).
Further research on the randomized phase 3 COMMANDS trial (NCT03682536) led to the expansion of the indication of luspatercept to the frontline setting for patients with anemia and lower-risk MDS. Zeidan discusses the rationale and design of the study, as well as how the use of luspatercept approximately doubled the proportion of patients who were RBC-transfusion independent compared with those patients on ESAs.
TRANSCRIPTION:
0:08 | Based on this, the COMMANDS trial was conducted, which tried to answer 2 questions. The first question was, what is the efficacy in the frontline setting against ESAs? And then the second question was about activity outside of the ring sideroblast setting. So, the COMMANDS study was a large international study, and actually, it was a positive study for the primary and many of the secondary end points. So, the main finding of COMMANDS was improvement in the rate of transfusion independence, which were for 12 weeks combined with a mean hemoglobin rise of 1.5 g/dL.
0:30 | This [occurred in] 60% with luspatercept compared to 30% with ESA, and based on this, the FDA has approved luspatercept also in the frontline setting for anemic patients who have anemia and who may require blood cell transfusions.
Peers Discuss Sacituzumab Govitecan in HR+ mBC Post Endocrine Therapy
July 24th 2024During a Case-Based Roundtable® event, Tiffany A. Traina, MD, surveyed participants on treatment for a patient who had progressed following endocrine therapy for metastatic breast cancer in the first article of a 2-part series.
Read More
Dato-DXd Shows Promise as a More Tolerable ADC in HER2-Negative mBC
July 22nd 2024During a Case-Based Roundtable® event, Igor Makhlin, MD, discussed with participants their impressions of datopotamab deruxtecan as therapy for patients with HR-positive, HER2-negative breast cancer, and the sequential use of multiple antibody-drug conjugates.
Read More
Similar Efficacy in Melanoma Shown in Indirect Comparison of PD-1/LAG3 vs PD-1/CTLA-4
July 16th 2024During a Case-Based Roundtable® event, Michael A. Postow, MD, discussed an indirect treatment comparison of nivolumab plus relatlimab vs nivolumab plus ipilimumab in patients with advanced melanoma in the first article of a 2-part series.
Read More
FDA Enforces Partial Hold on Trial of Seclidemstat in MDS/CMML
July 16th 2024Following the report of a serious and unexpected grade 4 adverse effect, a partial clinical hold has been placed on the phase 1 trial evaluating seclidemstat with azacitidine in myelodysplastic syndrome and chronic myelomonocytic leukemia.
Read More