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Anti–TIM-3 Monoclonal Antibody Under Study in AML

By: Joseph Fanelli
Posted: Thursday, November 12, 2020

For patients with acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS), the anti–TIM-3 monoclonal antibody sabatolimab appears to be “safe and well tolerated” when used with either decitabine or azacitidine, according to findings presented during the 2020 Society of Hematologic Oncology (SOHO) Annual Meeting (AML-190). The use of sabatolimab with hypomethylating agents also showed promising antileukemic activity, noted Guillermo Garcia-Manero, MD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues.

“These results underscore the potential of TIM-3 as a therapeutic target in myeloid malignancies and support further development of sabatolimab + hypomethylating agents in MDS and AML,” the authors concluded.

In this phase Ib, open-label study, the authors enrolled 105 patients with MDS and AML to receive sabatolimab with either decitabine (69 patients) or azacitidine (36 patients). Patients were excluded if they had received prior treatment with hypomethylating agents.

The authors found that patients with high-risk MDS treated with sabatolimab and decitabine had an overall response rate of 61.1%. Those treated with sabatolimab and azacitidine had a rate of 57.1%. As for those with newly diagnosed AML, the overall response rate with sabatolimab and decitabine was 47.1%, and for those treated with sabatolimab and azacitidine, it was 28.6%. The median time to response was 1.9 months for those who received decitabine and 2.5 months for those who received azacitidine.

The most common cause of treatment discontinuation was disease progression, the authors reported. Four patients from both cohorts discontinued treatment because of adverse events. The most common grade 3 or 4 treatment-emergent adverse events with decitabine were febrile neutropenia (47.8%), neutropenia (44.8%), and thrombocytopenia (40.6%); with azacitidine, they were thrombocytopenia (48.6%), neutropenia (43.2%), and febrile neutropenia (21.6%). There were no treatment-related deaths.

Disclosure: No disclosure information for the study authors was provided.



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