Independent Data Monitoring Committee recommends continuation of Phase III Study of uproleselan in r/r AML

“We thank the independent DMC for its recommendation and are strongly encouraged as the blinded pooled survival data continues to show patients living longer than historical benchmarks. Going forward, survival duration for new events in the study will be greater than 14 months since the last patient was randomized, giving us confidence in the potential for uproleselan to improve outcomes for people living with R/R AML,” said Harout Semerjian, Chief Executive Officer of GlycoMimetics. “We are proud to be advancing a novel treatment with significant potential to address the urgent unmet medical need in this acute leukemia, and we look forward to continuing the study to the originally planned final overall survival analysis, now expected within the first half of 2024.”

The interim utility analysis was added to the study in the fall of 2022 as blinded pooled survival data showed patients living longer than expected based on the historical benchmarks used to design the study. The plan for the independent DMC to review efficacy and safety data at approximately 80% of planned survival events was cleared with the FDA. When designing the interim analysis, the company amended the protocol to create the opportunity to achieve unblinding at around 80% of survival events while maintaining the integrity of the final analysis should the DMC recommend the study continue to the final overall events trigger. The interim analysis plan required a high statistical threshold to be met for the independent DMC to recommend unblinding, reserving approximately 95% of the study’s statistical power for the final analysis.