GlycoMimetics Announces Continuation of Phase 3 Study of E-selectin Antagonist Uproleselan in Relapsed/Refractory AML to Originally Planned Final Analysis Following Interim Analysis by Independent Data Monitoring Committee
- Independent Data Monitoring Committee recommended pivotal Phase 3 study continue to the originally planned final overall survival events trigger and expressed no concerns about safety
- Interim utility analysis was conducted using a very high statistical threshold to preserve the integrity of the originally planned final analysis
- Review of blinded pooled data shows patients continue to live longer than historical benchmarks; final survival event trigger now expected within first half of 2024
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“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
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
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.
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The pivotal Phase 3 trial evaluating uproleselan in addition to a cytarabine-based chemotherapy regimen in patients with relapsed/refractory AML completed enrollment in November of 2021. A total of 388 patients across 70 sites in nine countries were randomized in the clinical trial, which has a primary endpoint of overall survival.
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