Clinical outcomes and safety in patients with lower-risk myelodysplastic syndromes treated with imetelstat: Substudy of the phase 3 IMerge trial

Affiliations

¹ Moffitt Cancer Center, Tampa, Florida, USA.
² MDS Unit, Hematology, DMSC University of Florence, AOUC, Florence, Italy.
³ National Center for Tumor Diseases (NCT), University Hospital Carl Gustav Carus, TU Dresden, Dresden, Germany.
⁴ AZ Groeninge, Kortrijk, Belgium.
⁵ University Hospital of Salamanca, IBSAL, Universidad de Salamanca, Salamanca, Spain.
⁶ Servicio de Hematología y Hemoterapia, Hospital Universitario La Paz, Madrid, Spain.
⁷ Hospital Universitario y Politécnico La Fe, Valencia, Spain.
⁸ Health Research Institute La Fe, Valencia, Spain.
⁹ CIBERONC, ISCIII, Madrid, Spain.
¹⁰ Centre Hospitalier Universitaire d'Angers, Angers, France.
¹¹ Poznań University of Medical Sciences, Poznań, Poland.
¹² London North West University Healthcare NHS Trust, London, UK.
¹³ Sylvester Comprehensive Cancer Center, University of Miami, Miami, Florida, USA.
¹⁴ Hôpital Saint-Louis, Université de Paris 7, Paris, France.
¹⁵ Harold C. Simmons Comprehensive Cancer Center, UT Southwestern Medical Center, Dallas, Texas, USA.
¹⁶ Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
¹⁷ Geron Corporation, Foster City, California, USA.
¹⁸ Yale School of Medicine and Yale Cancer Center, Yale University, New Haven, Connecticut, USA.

Rami S Komrokji et al. Br J Haematol. 2025.

. 2025 Nov 30.

doi: 10.1111/bjh.70266. Online ahead of print.

¹ Moffitt Cancer Center, Tampa, Florida, USA.
² MDS Unit, Hematology, DMSC University of Florence, AOUC, Florence, Italy.
³ National Center for Tumor Diseases (NCT), University Hospital Carl Gustav Carus, TU Dresden, Dresden, Germany.
⁴ AZ Groeninge, Kortrijk, Belgium.
⁵ University Hospital of Salamanca, IBSAL, Universidad de Salamanca, Salamanca, Spain.
⁶ Servicio de Hematología y Hemoterapia, Hospital Universitario La Paz, Madrid, Spain.
⁷ Hospital Universitario y Politécnico La Fe, Valencia, Spain.
⁸ Health Research Institute La Fe, Valencia, Spain.
⁹ CIBERONC, ISCIII, Madrid, Spain.
¹⁰ Centre Hospitalier Universitaire d'Angers, Angers, France.
¹¹ Poznań University of Medical Sciences, Poznań, Poland.
¹² London North West University Healthcare NHS Trust, London, UK.
¹³ Sylvester Comprehensive Cancer Center, University of Miami, Miami, Florida, USA.
¹⁴ Hôpital Saint-Louis, Université de Paris 7, Paris, France.
¹⁵ Harold C. Simmons Comprehensive Cancer Center, UT Southwestern Medical Center, Dallas, Texas, USA.
¹⁶ Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
¹⁷ Geron Corporation, Foster City, California, USA.
¹⁸ Yale School of Medicine and Yale Cancer Center, Yale University, New Haven, Connecticut, USA.

No abstract available

Keywords: QTc; anaemia; clinical trial; efficacy; imetelstat; myelodysplastic syndromes; safety; transfusions.

References

1. Platzbecker U, Santini V, Fenaux P, Sekeres MA, Savona MR, Madanat YF, et al. Imetelstat in patients with lower‐risk myelodysplastic syndromes who have relapsed or are refractory to erythropoiesis‐stimulating agents (IMerge): a multinational, randomised, double‐blind, placebo‐controlled, phase 3 trial. Lancet. 2024;403:249–260.
1. RYTELO® (imetelstat) for injection, for intravenous use. Package insert. Geron Corporation. 2024.
1. RYTELO® (imetelstat) summary of product characteristics. Geron Corporation. 2025.
1. United States Food and Drug Administration, Department of Health and Human Services. International Conference on Harmonisation; guidance on S7B nonclinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals; availability. Notice. Fed Regist. 2005;70:61133–61134.
1. United States Food and Drug Administration, Department of Health and Human Services. International Conference on Harmonisation; guidance on E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non‐antiarrhythmic drugs; availability. Notice. Fed Regist. 2005;70:61134–61135.