Biotherapeutics company PureTech Health plc reported on Wednesday that its founded entity Gallop Oncology reported positive topline Phase 1b data for LYT-200 in relapsed/refractory high-risk myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML).
The study showed complete responses and a favourable safety profile across 101 heavily pretreated patients, with no dose-limiting toxicities or treatment-related serious adverse events.
In efficacy-evaluable patients, LYT-200 combined with standard therapies achieved a 45.5% overall response rate in MDS and 42.3% in AML. The company has selected a Phase 2 dose and plans to engage with the U.S. Food and Drug Administration on a potential registrational study in MDS.
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