Apollomics' Uproleselan Fails Phase 3 Trial in Relapsed/Refractory AML
核心洞察
Apollomics' Phase 3 trial of uproleselan in China did not meet its primary endpoint, showing no significant benefit in overall survival for patients with relapsed or refractory AML (搜索).
The median overall survival in the uproleselan arm was 9.3 months, compared to 14.3 months in the chemotherapy-only arm, indicating a potential detriment with the addition of uproleselan.
Due to the trial's failure and a previous unsuccessful global Phase 3 trial, Apollomics is discontinuing the uproleselan program, with remaining expenses expected to be under $500,000.
Apollomics Inc. has announced disappointing results from its Phase 3 bridging trial of uproleselan in China for patients with relapsed or refractory acute myeloid leukemia (搜索) (AML (搜索)). The randomized, double-blinded trial, which included 140 patients, failed to demonstrate a favorable benefit when comparing uproleselan plus chemotherapy to chemotherapy alone.
The trial's primary endpoint was overall survival (OS). Patients receiving uproleselan in combination with chemotherapy had a median OS of 9.3 months (95% CI: 6.1 – 16.0 months), while those receiving chemotherapy alone had a median OS of 14.3 months (95% CI: 6.2 – NA months). The p-value was 0.48, indicating the difference was not statistically significant. The addition of uproleselan to chemotherapy was generally well-tolerated, with a similar safety profile to the control arm. However, the incidence of serious adverse events was slightly higher in the uproleselan arm (43%) compared to the chemotherapy-only arm (39%). Common serious adverse events in the uproleselan arm included decreased platelet count, infectious pneumonia, and sepsis.
Program Discontinuation and Financial Implications
Guo-Liang Yu, PhD, Chairman and CEO of Apollomics, stated that the results were expected, given the previous failure of a global Phase 3 trial of uproleselan by their partner, Glycomimetics (搜索). He added that the company's regulatory and commercial strategy in China required a positive global Phase 3 trial, leading to the decision to discontinue the program. Apollomics had already written down the intangible asset related to the upfront payment for the uproleselan program in August 2024 and expects future expenses to be less than $500,000.
Focus on Vebreltinib (APL-101)
With the uproleselan program being discontinued, Apollomics will now focus on its lead program, vebreltinib (APL-101), a potent, selective c-Met (搜索) inhibitor. Vebreltinib is currently in a Phase 2 multicohort clinical trial for the treatment of non-small cell lung cancer (搜索) and other advanced tumors with c-Met alterations. The company intends to submit the full results of the uproleselan trial for presentation at a future medical conference.
About Uproleselan
Uproleselan is a drug designed to target E-selectin, a cell adhesion molecule that plays a role in the interaction between cancer cells and the bone marrow microenvironment. The hypothesis was that by blocking this interaction, uproleselan could improve the efficacy of chemotherapy in AML (搜索). However, the Phase 3 trial results did not support this hypothesis.