In a financial report, Novartis revealed that its anti-TIM-3 antibody, sabatolimab, failed a crucial phase 3 blood cancer trial.
The study, focusing on patients with myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia-2, showed no survival improvement with azacitidine plus sabatolimab (MBG453) compared to placebo. Consequently, Novartis has halted sabatolimab's development.
Sabatolimab is a therapeutic agent designed to target the TIM-3 protein, a cell surface receptor involved in regulating the immune response. By inhibiting TIM-3, sabatolimab aims to enhance the anti-tumor immune response, particularly in cancer cells expressing TIM-3.
In 2021, the FDA granted fast track designation to the therapy for the treatment of adult patients with MDS characterized by a high or very high IPSS-R risk category when combined with hypomethylating agents.
MDS, a group of rare and often underdiagnosed blood cancers, is marked by a compromised immune system and the proliferation of leukemic stem cells. Despite recent treatment innovations like hypomethylating agents in higher-risk MDS, patients still face poor outcomes, including limited response duration and a median overall survival rate of less than a year.
