PureTech Health presented positive Phase 1b trial data for LYT-200, a novel anti-galectin-9 monoclonal antibody, in patients with relapsed or refractory acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). The trial evaluated LYT-200 as a monotherapy and in combination with standard-of-care venetoclax and hypomethylating agents (HMAs). Early results indicate a favorable safety profile and promising efficacy, including partial and complete responses and prolonged disease stabilization.
Relapsed/refractory AML carries a grim prognosis, with limited effective treatment options and short survival times. The data presented suggest that LYT-200 could address this unmet need by providing a new therapeutic approach with the potential to improve outcomes for these patients, either as a standalone therapy or in combination with existing treatments. This is also important for the company as they intend to advance LYT-200 through a Founded Entity called Gallop Oncology.
In the monotherapy arm, 59% of evaluable patients achieved stable disease or better, with two partial responses observed. The mean duration on treatment exceeded two months, notably longer than the typical survival time for patients refractory to venetoclax/HMA therapy. In the combination arm, 80% of evaluable patients achieved stable disease or better, with two complete responses and one patient achieving morphologic leukemia-free state. The mean duration of treatment in the combination arm also surpassed two months. Importantly, LYT-200 demonstrated clinical benefit across various genetic subtypes, including patients with complex cytogenetics and mutations like KRAS, NRAS, and BRAF, who often have poorer responses to standard therapies. Pharmacodynamic analyses confirmed LYT-200’s dual mechanism of action, directly targeting cancer cells and reactivating the immune system.
These promising Phase 1b results pave the way for further clinical development of LYT-200. The data support advancing LYT-200 into a Phase 2 trial for relapsed/refractory AML/MDS, potentially offering a much-needed new treatment option for this challenging patient population. The dual mechanism of action, coupled with the favorable safety profile and evidence of efficacy, positions LYT-200 as a potential game-changer in AML/MDS therapy. Further studies will be crucial to confirm these initial findings and define the optimal role of LYT-200 in the treatment paradigm. The potential for LYT-200 to improve outcomes for patients with relapsed/refractory AML/MDS is substantial, and its continued development represents a significant step forward in the fight against these aggressive blood cancers.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
