Gallop Oncology reported that its Phase 1b study of the anti‑galectin‑9 antibody LYT‑200 produced striking topline data in patients with relapsed or refractory acute myeloid leukemia (AML) and high‑risk myelodysplastic syndrome (MDS). The 101‑patient trial, which enrolled heavily pre‑treated individuals, showed a median overall survival of 13.2 months in the combination cohort receiving LYT‑200 with venetoclax and a hypomethylating agent—an improvement that far exceeds the typical <2.5‑month survival seen in this setting.
In the same cohort, 33 % of patients achieved a complete response, and half of those responders went on to stem‑cell transplant. The durable benefit is underscored by a 27‑month partial response in a single monotherapy patient, while the median overall survival in the monotherapy arm was 6.5 months. These figures represent a meaningful clinical advance for a population with limited options.
Safety data were encouraging: no LYT‑200‑related serious adverse events or dose‑limiting toxicities were reported, and the combination with venetoclax and a hypomethylating agent did not produce overlapping toxicities. The favorable safety profile supports the feasibility of moving the drug into a larger, phase 2 program.
The results de‑risk LYT‑200’s development and broaden its potential applicability across high‑risk mutations such as KRAS, NRAS, JAK2, and KIT. LYT‑200 already holds Fast Track and Orphan Drug designations from the FDA for AML, and the positive data strengthen the case for regulatory engagement and partnership opportunities. The company plans to present additional data at the 67th American Society of Hematology meeting on December 6, 2025, and will seek regulatory feedback as overall‑survival data mature.
"These results represent a step change in the treatment of AML for patients who have exhausted standard options," said Luba Greenwood, CEO of Gallop Oncology. "The combination’s survival benefit, high response rate, and manageable safety profile give us confidence to advance LYT‑200 into a definitive phase 2 trial and to explore its use across a broader spectrum of high‑risk disease.”
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