https://orcid.org/0000-0001-7017-8160
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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).
Clinical Trial Registration: NCT04266301 (ClinicalTrials.gov)
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Supplementary data
An infographic accompanies this paper. To view or download this infographic in your browser please click here: https://www.tandfonline.com/doi/suppl/10.2217/fon-2022-1237
Author contributions
All authors met the criteria for authorship set forth by the International Committee of Medical Journal Editors, and were involved in conception, preparation, and approval of the manuscript. AM Zeidan serves as the primary author and V Santini is the senior author for this manuscript
Acknowledgments
The authors would like to thank the patients and their families, investigators, co-investigators, and the study teams at each of the participating centers. Medical writing assistance was provided by JAN Javier, MD, of Healthcare Consultancy Group, (NY, USA), and was funded by Novartis Pharmaceuticals Corporation, (NJ, USA).
Financial & competing interests disclosure
AM Zeidan is a Leukemia and Lymphoma Society Scholar in Clinical Research. AM Zeidan received research funding (institutional) from Celgene/BMS, AbbVie, Astex, Pfizer, Medimmune/AstraZeneca, Boehringer-Ingelheim, Cardiff Oncology, Incyte, Takeda, Novartis, Aprea, and ADC Therapeutics. AM Zeidan participated in advisory boards and/or had a consultancy with and received honoraria from AbbVie, Otsuka, Pfizer, Celgene/BMS, Jazz, Incyte, Agios, Boehringer-Ingelheim, Novartis, Acceleron, Astellas, Daiichi Sankyo, Cardinal Health, Taiho, Seattle Genetics, BeyondSpring, Cardiff Oncology, Takeda, Ionis, Amgen, Janssen, Genentech, Epizyme, Syndax, Gilead, Kura, Chiesi, ALX Oncology, BioCryst, Notable, Orum, Mendus, Foran, Syros, and Tyme. AM Zeidan served on clinical trial committees for Novartis, AbbVie, Gilead, BioCryst, ALX Oncology, Geron, and Celgene/BMS. AM Zeidan received travel support for meetings from Pfizer, Novartis, and Cardiff Oncology. A Giagounidis has received honoraria from Bristol Myers Squibb. MA Sekeres has served on advisory boards for Bristol Myers Squibb, Novartis, and Kurome. Z Xiao has no disclosures. G Sanz reports consultancy and membership on the Board of Directors or advisory committees for Celgene, AbbVie, Helsinn Healthcare, Novartis, and Takeda. GS has received honoraria and research funding from Helsinn Healthcare and Takeda. GS reports teaching and speaking at Janssen Pharmaceuticals, Inc. M Van Hoef is an employee of Novartis Pharma AG. F Ma is an employee of Novartis Pharmaceuticals Corporation. S Hertle is an employee of Novartis Pharma AG. V Santini has served on advisory boards for BMS, AbbVie, Geron, Gilead, Menarini, Novartis, Syros, Servier, Otsuka, and Takeda. VS has received travel grants from Janssen. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Medical writing assistance was provided by JAN Javier of Healthcare Consultancy Group, (NY, USA), and was funded by Novartis Pharmaceuticals Corporation, (NJ, USA).
Ethical conduct of research
This trial was designed, implemented, and reported in accordance with the ICH Harmonized Tripartite Guidelines for GCP, applicable local regulations, and the Declaration of Helsinki. Investigators/institutions conducted the trial in accordance with their Institutional Review Boards/Independent Ethics Committees. Informed consent was obtained from all patients before inclusion in the trial.