What's New?

Geron Corporation has initiated patient screening and enrollment for the Phase 3 portion of IMerge, a clinical trial assessing imetelstat, a telomerase inhibitor, in lower risk myelodysplastic syndromes (MDS). This phase aims to confirm the positive outcomes observed in the Phase 2 segment, evaluating imetelstat's potential as a treatment option for patients with lower risk MDS who are relapsed after or refractory to erythroid stimulating agents (ESAs). The trial will enroll approximately 170 patients globally and is expected to deliver top-line results by mid-year 2022. Imetelstat has shown promise in providing transfusion independence and disease-modifying activity in previous studies. Geron remains optimistic about the potential of imetelstat in addressing the unmet needs of patients with lower risk MDS.

Celgene Corporation and Acceleron Pharma Inc. have submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for luspatercept, an investigational therapy, for the treatment of adult patients with very low to intermediate-risk myelodysplastic syndromes (MDS)-associated anemia and beta-thalassemia-associated anemia who require red blood cell transfusions. The submission follows the Biologics Licensing Application submission to the U.S. FDA earlier this month. Luspatercept, a first-in-class erythroid maturation agent, demonstrated promising safety and efficacy results in the pivotal phase 3 studies MEDALIST and BELIEVE. The companies aim to address the anemia associated with these serious diseases and reduce the burden of transfusions. Both companies are optimistic about luspatercept's potential as a therapeutic option and await regulatory review and approval.