Uproleselan

Apollomics' Phase 3 trial of uproleselan in China for relapsed or refractory acute myeloid leukemia did not show favorable benefit. Median OS was 9.3 months in the uproleselan arm vs. 14.3 months in the chemotherapy-only arm. The trial was generally well tolerated, with similar safety profiles in both arms.

Apollomics Inc. announced the results of its Phase 3 bridging trial of uproleselan in China, which did not meet its primary endpoint. The trial involved patients with relapsed or refractory acute myeloid leukemia (AML). Despite the setback, the company maintains a healthy current ratio of 2.25, suggesting adequate liquidity. Apollomics' lead program is now vebreltinib (APL-101), a c-Met inhibitor in a Phase 2 multicohort clinical trial for non-small cell lung cancer and other advanced tumors with c-Met alterations.

GlycoMimetics to present uproleselan AML trial data at the 66th ASH Annual Meeting in San Diego, Dec 7-10, 2024, including Phase 3 findings on efficacy and safety with chemotherapy, updated Phase 1 results, and final Phase 2 results.

A phase 2/3 study (NCT03701308) found that combining uproleselan with 7+3 chemotherapy did not significantly improve event-free survival (EFS) for older patients with newly diagnosed AML compared to chemotherapy alone. The trial, enrolling patients aged 60 and older, did not meet its primary EFS endpoint in phase 2. The National Cancer Institute and the Alliance for Clinical Trials in Oncology plan to analyze subgroup efficacy for potential further research. Earlier phase 3 trial results showed a modest overall survival benefit with uproleselan in relapsed or refractory AML patients.

Combining uproleselan with 7+3 chemotherapy did not significantly improve event-free survival (EFS) in older patients with newly diagnosed AML eligible for intensive chemotherapy, according to a phase 2/3 study (NCT03701308). The study's primary endpoint of EFS was not met, and further subgroup analysis is ongoing to identify potential efficacy signals. Topline data from the trial will be presented at a future medical meeting.

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