Maryland-based GlycoMimetics revealed this week that the phase 3 trial for its relapsed/refractory acute myeloid leukemia drug, uproleselan, had not met its primary endpoint of overall survival.
The phase 3, randomized, double-blind, placebo-controlled trial included included 388 patients and evaluated uproleselan alongside chemotherapy R/R AML patients. The study's primary endpoint was overall survival without transplant censoring.
In the trial, the combination of uproleselan with chemotherapy did not yield a statistically significant improvement in overall survival compared to chemotherapy alone. Participants administered with uproleselan exhibited a median overall survival of 13 months, only slightly surpassing the 12.3 months seen in the placebo group.
Uproleselan is a potential a first-in-class e-selectin antagonist. In AML, e-selectin plays a role in promoting leukemic cell survival and protecting them from therapy. Uproleselan is designed to disrupt this interaction, potentially making the leukemia cells more vulnerable to treatment.
According to GlycoMimetics, a phase 2/3 study of uproleselan in older adults with newly diagnosed AML who are a fit for intensive chemotherapy, conducted by the NCI and the Alliance for Clinical Trials in Oncology, remains ongoing.
