What's Happening?
Gallop Oncology, a subsidiary of PureTech Health, has announced positive initial results from its Phase 1b clinical trial of LYT-200, a monoclonal antibody targeting galectin-9, in patients with relapsed/refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome. The trial demonstrated favorable tolerability and strong efficacy, with an initial median overall survival of 13.2 months in the combination cohort, significantly exceeding the expected survival of less than 2.5 months in this patient population. The study involved LYT-200 both as a monotherapy and in combination with standard-of-care treatments, showing promising responses even in patients with high-risk mutations. These findings support the advancement of LYT-200 into
a potentially registrational Phase 2 trial.
Why It's Important?
The results from the LYT-200 trial are significant as they offer a potential new treatment avenue for patients with relapsed/refractory AML, a condition with limited treatment options and poor prognosis. The observed efficacy and safety profile of LYT-200 could lead to improved survival rates and quality of life for patients. The trial's success underscores the potential of targeting galectin-9, a key oncogenic driver, in treating AML and possibly other cancers. This development could influence future research and treatment strategies in oncology, particularly for diseases with high unmet medical needs.
What's Next?
Gallop Oncology plans to advance LYT-200 into a Phase 2 trial, with further engagement with regulatory authorities expected once the overall survival data mature. The company aims to explore the broader applicability of LYT-200 in earlier lines of treatment and other cancer types. The final overall survival results are anticipated in the first half of 2026, which will guide the next steps in the drug's development and potential approval process.
