GlycoMimetics Announces U.S. Food and Drug Administration Clears Addition of Time-based Final Analysis to Pivotal Phase 3 Study of Uproleselan in Relapsed/Refractory Acute Myeloid Leukemia
- Final analysis to be conducted after the earlier of 295 survival events or the FDA-aligned cutoff date; topline results expected by the end of Q2 2024
- Prolonged duration of blinded pooled survival in relapsed/refractory Acute Myeloid Leukemia expected to yield clinically mature dataset in Q2 2024, supporting addition of time-based analysis of overall survival primary endpoint
- Dataset is expected to reflect greater than three years of median follow-up, including at least two years of post-transplant data for a large majority of patients who received stem cell transplantation
“We are pleased the FDA cleared the addition of a time-based pathway to final analysis as it provides the opportunity to evaluate the effect of uproleselan on R/R AML based on a clinically mature database with more than three years median follow-up,” said
The Phase 3 trial completed enrollment of 388 patients across 70 sites in nine countries in
Based on blinded pooled data observed to date, a time-based final analysis in Q2 2024 is expected to yield a clinically mature dataset to evaluate uproleselan in R/R AML. This dataset is expected to reflect a median follow-up of greater than three years, including at least two years of post-transplant data. The majority of surviving patients in the study received hematopoietic stem cell transplantation (HSCT). As a result, the company believes the capture rate of survival events for this study beyond Q2 2024 would provide limited additional value for the primary analysis.
Two years post-transplant is generally considered an important milestone in AML because most patients who survive at least two years post-transplant without experiencing disease relapse are typically deemed to be long-term survivors. For patients over two years post-transplant, disease relapse is less likely.1
As part of the protocol amendment, the FDA also cleared the addition of landmark EFS and overall survival analyses as secondary endpoints.
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This press release contains forward-looking statements. These forward-looking statements may include, but are not limited to, statements regarding the conduct of and data from clinical trials, planned or potential clinical development, regulatory interactions and submissions, and the potential benefits and impact of the company’s drug candidate, uproleselan. Actual results may differ materially from those described in these forward-looking statements. For a further description of the risks associated with these statements, as well as other risks facing
1 Bolon YT, Atshan R,
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