STIMULUS-MDS2 design and rationale: a phase III trial with the anti-TIM-3 sabatolimab (MBG453) + azacitidine in higher risk MDS and CMML-2.
| Autor: | Zeidan AM; Yale University & Yale Cancer Center, New Haven, CT 06510, USA., Giagounidis A; Marien Hospital Düsseldorf, Düsseldorf, 40479, Germany., Sekeres MA; Division of Hematology, Sylvester Cancer Center, University of Miami, Miami, FL 33065, USA., Xiao Z; Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, 300020, China., Sanz GF; Hospital Universitario y Politécnico La Fe, Valencia, 46026, Spain.; Health Research Institute La Fe (IIS La Fe), Valencia, 46026, Spain.; CIBERONC, Instituto de Salud Carlos III, Madrid, 28029, Spain., Hoef MV; Novartis Pharma AG, Basel, 4056, Switzerland., Ma F; Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, USA., Hertle S; Novartis Pharma AG, Basel, 4056, Switzerland., Santini V; MDS Unit, Hematology, University of Florence, Florence, 50121, Italy. |
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| Jazyk: | angličtina |
| Zdroj: | Future oncology (London, England) [Future Oncol] 2023 Mar; Vol. 19 (9), pp. 631-642. Date of Electronic Publication: 2023 Apr 21. |
| DOI: | 10.2217/fon-2022-1237 |
| Abstrakt: | Patients with higher-risk myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML) unfit for hematopoietic stem cell transplantation have poor outcomes. Novel therapies that provide durable benefit with favorable tolerability and clinically meaningful improvement in survival are needed. T-cell immunoglobulin domain and mucin domain-3 (TIM-3) is an immuno-myeloid regulator expressed on immune and leukemic stem cells in myeloid malignancies. Sabatolimab is a novel immunotherapy targeting TIM-3 with a potential dual mechanism of reactivating the immune system and directly targeting TIM-3+ leukemic blasts suppressing the growth of cancer cells. Here, we describe the aims and design of the phase III STIMULUS-MDS2 trial, which aims to demonstrate the potential for sabatolimab plus azacitidine to improve survival for patients with higher-risk MDS and CMML-2 (NCT04266301). Clinical Trial Registration : NCT04266301 (ClinicalTrials.gov). |
| Databáze: | MEDLINE |
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