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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.
Backround
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).
Methods
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.
Results
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.
Conclusions
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.
References:
- https://ashpublications.org/blood/article/138/Supplement%201/244/478172/Efficacy-and-Safety-of-Sabatolimab-MBG453-in
- https://jhoonline.biomedcentral.com/articles/10.1186/s13045-022-01346-9
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.
Backround
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).
Methods
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.
Results
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.
Conclusions
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.
References:
- https://ashpublications.org/blood/article/138/Supplement%201/244/478172/Efficacy-and-Safety-of-Sabatolimab-MBG453-in
- https://jhoonline.biomedcentral.com/articles/10.1186/s13045-022-01346-9
about the author
Jimena Vicencio
Jimena is an International Medical Graduate and a member of the HealthTree Writing team. She has a passion for languages and is currently learning Japanese. In her free time, she loves playing with her cats. Jimena is also pursuing a bachelor's degree in journalism.
