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Sabatolimab in Patients with Very High/High-Risk MDS and AML
Posted: Jul 11, 2023
Sabatolimab in Patients with Very High/High-Risk MDS and AML image

Sabatolimab in Patients with Very High/High-Risk MDS and AML

Sabatolimab binds to the surface of T-cells, releasing the breaks that the tumor applied to the immune system. (HMA) or hypomethylating agents act by inducing DNA hypomethylation and corresponding alterations in gene expression.

Patients with higher-risk MDS and AML need treatment options that provide stable responses with sustained clinical benefit and favorable safety/tolerability. Sabatolimab in combination with a hypomethylating agent was cited comprehensively in MDS sessions at ASH 2022, in this article, the highlights of the clinical trial will be presented. 


TIM-3 is an immune regulator expressed on immune cells and myeloid leukemic progenitors but not on normal hematopoietic stem cells. Sabatolimab + HMA (hypomethylating agent) has been shown to deliver promising durable responses in a phase Ib study in patients with vHR/HR-MDS (very high-risk/high-risk myelodysplastic syndrome) or newly diagnosed AML (acute myeloid leukemia) (Wei et al. EHA 2021; NCT03066648). 


The primary objective was to evaluate safety and tolerability. A secondary objective, preliminary efficacy, was assessed with overall response rate, duration of response, and progression-free survival endpoints. The proportion of patients who had a possible immune-mediated adverse event was evaluated among patients who achieved remission compared with those who did not. 


As of the 15 Jun 2021 data cutoff, 53 patients with very high risk/high-risk MDS and 48 with ND-AML were treated with sabatolimab + HMA. The combination was safe and well tolerated, with the most common adverse effects similar to HMA alone, consisting of thrombocytopenia, neutropenia, anemia, and febrile neutropenia. No pt with vHR/HR-MDS and only 3 with ND-AML discontinued treatment due to an adverse effect regardless of relationship to treatment. 

In very high-risk/ high risk MDS, 24.5% of patients had improvement allowing them to undergo HSCT (hematopoietic stem cell transplantation). 

Long-lasting responses were also observed in patients with adverse-risk mutations, including TP53 mutations in patients with very high risk/high-risk MDS and at least 1 ELN (European LeukemiaNet) adverse-risk mutation (TP53/RUNX1/ASXL1) in patients with newly diagnosed AML. 


Sabatolimab + Hypomethylating agents  was safe and well tolerated and demonstrated stable clinical responses in patients with very high risk/high-risk-MDS and newly diagnosed-AML. Responses were also durable in patients with adverse-risk mutations. 


The author Jimena Vicencio

about the author
Jimena Vicencio

Jimena is an International Medical Graduate who is part of the HealthTree Patient Experience team. She loves learning new things led by her curiosity, playing with her pets, and exercising in her free time.

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