The STIMULUS-MDS2 trial of sabatolimab + azacitidine did not meet its primary endpoint for subjects with intermediate, high, or very high-risk myelodysplastic syndromes
The STIMULUS-MDS2 trial was testing sabatolimab (MBG453) in combination with azacitidine in previously untreated adult subjects with intermediate, high, or very high-risk myelodysplastic syndromes (MDS) who were not eligible for intensive chemotherapy or a haematopoietic stem cell transplantation (HSCT)
In its fourth-quarter results update, Novartis revealed that the programme was being discontinued to prioritise other programmes in its portfolio because STIMULUS-MDS2 had not met its primary endpoint. The study’s main objective was to show an improvement in overall survival for the combination compared to azacitidine plus placebo. It started in 2020 and had been due to follow up patients for five years, with a main readout due in 2027. Sabatolimab also missed the mark in the phase II STIMULUS-MDS1 study, which also looked at the combination of the drug with azacitidine in previously untreated higher-risk MDS and was published in The Lancet Haematology journal earlier this month.
See- VOLUME 11, ISSUE 1, E38-E50, JANUARY 2024. "Sabatolimab plus hypomethylating agents in previously untreated patients with higher-risk myelodysplastic syndromes (STIMULUS-MDS1): a randomised, double-blind, placebo-controlled, phase II trial". The Lancet Haematology.,Amer M Zeidan, MBBS , Kiyoshi Ando, MD, Odile Rauzy, MD, et al. Published: December 05, 2023DOI:https://doi.org/10.1016/S2352-3026(23)00333-2.
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