GlycoMimetics Phase 3 Leukemia Study Fails

GlycoMimetics says its Phase 3 study of uproleselan combined with chemotherapy in relapsed/refractory acute myeloid leukemia (AML) patients “did not achieve a statistically significant improvement in overall survival in the intent to treat population versus chemotherapy alone.” The company says it is analyzing the data in collaboration with medical, statistical and regulatory experts and committed to submitting a comprehensive data analysis for presentation at an upcoming medical meeting.

GlycoMimetics says a National Cancer Institute and Alliance for Clinical Trials in Oncology adaptive Phase 2/3 study of uproleselan is ongoing in adults with newly diagnosed AML who are 60 years or older and fit for intensive chemotherapy. The randomized, controlled study is evaluating the addition of uproleselan to a standard cytarabine/daunorubicin regimen versus chemotherapy alone. The Phase 2 portion of the study completed enrollment of 267 patients in December 2021.