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).
STIMULUS-MDS2 design and rationale: a phase III trial with the anti-TIM-3 sabatolimab (MBG453) + azacitidine in higher risk MDS and CMML-2 / Zeidan, Amer M; Giagounidis, Aristoteles; Sekeres, Mikkael A; Xiao, Zhijian; Sanz, Guillermo F; Hoef, Marlies Van; Ma, Fei; Hertle, Sabine; Santini, Valeria. - In: FUTURE ONCOLOGY. - ISSN 1479-6694. - ELETTRONICO. - 19:(2023), pp. 631-642. [10.2217/fon-2022-1237]
STIMULUS-MDS2 design and rationale: a phase III trial with the anti-TIM-3 sabatolimab (MBG453) + azacitidine in higher risk MDS and CMML-2
Santini, Valeria
2023
Abstract
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).File | Dimensione | Formato | |
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zeidan-et-al-2023-stimulus-mds2-design-and-rationale-a-phase-iii-trial-with-the-anti-tim-3-sabatolimab-(mbg453).pdf
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zeidan-et-al-2023-stimulus-mds2-design-and-rationale-a-phase-iii-trial-with-the-anti-tim-3-sabatolimab-%28mbg453%29.pdf
accesso aperto
Tipologia:
Pdf editoriale (Version of record)
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Open Access
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1.65 MB
Formato
Adobe PDF
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1.65 MB | Adobe PDF |
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