Phase Ib study of sabatolimab (MBG453), a novel immunotherapy targeting TIM-3 antibody, in combination with decitabine or azacitidine in high- or very high-risk myelodysplastic syndromes

Andrew M Brunner; Jordi Esteve; Kimmo Porkka; Steve Knapper; Elie Traer; Sebastian Scholl; Guillermo Garcia-Manero; Norbert Vey; Martin Wermke; Jeroen J W M Janssen; Rupa Narayan; Shaun Fleming; Sun Loo; Natalia Tovar; Mika Kontro; Oliver G Ottmann; Purushotham Naidu; Haiying Sun; May Han; Roisin White; Na Zhang; Anisa Mohammed; Catherine A Sabatos-Peyton; David P Steensma; Mikael L Rinne; Uma M Borate; Andrew H Wei

doi:10.1002/ajh.27161

Phase Ib study of sabatolimab (MBG453), a novel immunotherapy targeting TIM-3 antibody, in combination with decitabine or azacitidine in high- or very high-risk myelodysplastic syndromes

Am J Hematol. 2024 Feb;99(2):E32-E36. doi: 10.1002/ajh.27161. Epub 2023 Nov 22.

Authors

Andrew M Brunner¹, Jordi Esteve², Kimmo Porkka³, Steve Knapper⁴, Elie Traer⁵, Sebastian Scholl⁶, Guillermo Garcia-Manero⁷, Norbert Vey⁸, Martin Wermke⁹, Jeroen J W M Janssen¹⁰, Rupa Narayan¹, Shaun Fleming¹¹, Sun Loo¹¹, Natalia Tovar², Mika Kontro³, Oliver G Ottmann⁴, Purushotham Naidu¹², Haiying Sun¹², May Han¹³, Roisin White¹⁴, Na Zhang¹⁵, Anisa Mohammed¹², Catherine A Sabatos-Peyton¹⁶, David P Steensma¹⁵, Mikael L Rinne¹⁷, Uma M Borate⁵, Andrew H Wei¹⁸

Affiliations

¹ Massachusetts General Hospital, Boston, Massachusetts, USA.
² Hospital Clínic, Barcelona, Spain.
³ Helsinki University Hospital Comprehensive Cancer Center, Helsinki, Finland.
⁴ School of Medicine, Cardiff University, Cardiff, UK.
⁵ Oregon Health & Science University, Portland, Oregon, USA.
⁶ University Hospital Jena, Jena, Germany.
⁷ MD Anderson Cancer Center, Houston, Texas, USA.
⁸ Institut Paoli-Calmettes, Marseille, France.
⁹ TU Dresden, NCT/UCC Early Clinical Trial Unit, Dresden, Germany.
¹⁰ Amsterdam University Medical Centers, Amsterdam, The Netherlands.
¹¹ The Alfred Hospital, Melbourne, Victoria, Australia.
¹² Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
¹³ Cure Ventures, Boston, Massachusetts, USA.
¹⁴ Novartis Ireland Limited, Dublin, Ireland.
¹⁵ Novartis Institutes for BioMedical Research, Cambridge, Massachusetts, USA.
¹⁶ Larkspur Biosciences, Cambridge, Massachusetts, USA.
¹⁷ Blueprint Medicines, Cambridge, Massachusetts, USA.
¹⁸ The Peter MacCallum Cancer Centre and Royal Melbourne Hospital Walter and Eliza Hall Institute of Medical Research, Melbourne, Victoria, Australia.

PMID: 37994196
DOI: 10.1002/ajh.27161

Abstract

The safety and efficacy of sabatolimab, a novel immunotherapy targeting T-cell immunoglobulin domain and mucin domain-3 (TIM-3), was assessed in combination with hypomethylating agents (HMAs) in patients with HMA-naive revised International Prognostic System Score (IPSS-R) high- or very high-risk myelodysplastic syndromes (HR/vHR-MDS) or chronic myelomonocytic leukemia (CMML). Sabatolimab + HMA had a safety profile similar to that reported for HMA alone and demonstrated durable clinical responses in patients with HR/vHR-MDS. These results support the ongoing evaluation of sabatolimab-based combination therapy in MDS, CMML, and acute myeloid leukemia.

Publication types

Clinical Trial, Phase I
Letter
Research Support, Non-U.S. Gov't

MeSH terms

Antibodies / therapeutic use
Antibodies, Monoclonal*
Antimetabolites, Antineoplastic / therapeutic use
Azacitidine / therapeutic use
Decitabine / therapeutic use
Hepatitis A Virus Cellular Receptor 2 / therapeutic use
Humans
Leukemia, Myeloid, Acute* / drug therapy
Leukemia, Myelomonocytic, Chronic* / drug therapy
Myelodysplastic Syndromes* / drug therapy
Treatment Outcome

Substances

Azacitidine
Decitabine
sabatolimab
Antimetabolites, Antineoplastic
Hepatitis A Virus Cellular Receptor 2
Antibodies
Antibodies, Monoclonal

Grants and funding

Novartis Pharmaceuticals Corporation