Apollomics Reports Phase 3 Uproleselan Trial Results for AML in China

On December 20, 2024, Apollomics Inc., a biopharmaceutical firm listed on Nasdaq under the ticker APLM, shared the outcomes of its Phase 3 trial for uproleselan in China. Uproleselan is a drug developed for patients battling relapsed or refractory acute myeloid leukemia. Unfortunately, the study concluded without demonstrating significant benefits for those treated with uproleselan.

The clinical trial was set up as a randomized, double-blinded study. It aimed to assess the safety and effectiveness of combining uproleselan with chemotherapy, compared to chemotherapy alone, in individuals facing challenging leukemia cases. A focal point of the study was to compare overall survival rates between the treatment group receiving uproleselan and the control group receiving only chemotherapy. The trial enrolled 140 participants, who were evenly divided into two groups: 69 patients received both uproleselan and chemotherapy, while 71 patients were treated with chemotherapy alone.

Results showed that the median overall survival for patients in the uproleselan group was 9.3 months, with a confidence interval ranging from 6.1 to 16.0 months. In contrast, those receiving only chemotherapy had a median overall survival of 14.3 months, with a confidence interval from 6.2 months onwards. The statistical analysis showed no significant difference with a p-value of 0.48. The addition of uproleselan was generally well tolerated by patients, with its safety profile closely aligning with that of the chemotherapy-only group. The occurrence of serious adverse events was slightly higher in the uproleselan group at 43%, compared to 39% in the chemotherapy group. Common severe issues in the uproleselan group included decreased platelet count, infectious pneumonia, and sepsis.

Guo-Liang Yu, PhD, the Chairman and CEO of Apollomics, expressed disappointment at the lack of clinical benefit observed in the trial. He noted that these results were expected, referencing a similar global Phase 3 trial conducted by their partner Glycomimetics, which also failed to meet its primary endpoint earlier in the year. Yu emphasized that the regulatory and commercial strategy in China was contingent upon positive results from a global Phase 3 trial, prompting the decision to conclude the uproleselan program. He extended gratitude to the patients, their families, and the clinical team involved in the trial.

Earlier in August 2024, Apollomics announced a financial write-down related to the initial payment for the uproleselan program. With the trial coming to an end, the company anticipates that any remaining expenses for the uproleselan program will stay under $500,000. Apollomics also plans to present the complete trial results at an upcoming medical conference.

In addition to this trial, Apollomics Inc. continues its pioneering work in oncology, focusing on creating therapies that can be integrated with other treatments to utilize the immune system and specifically target molecular pathways that inhibit cancer. A significant development in their pipeline is vebreltinib (APL-101), a strong, selective inhibitor of c-Met aimed at treating non-small cell lung cancer and other advanced tumors with c-Met alterations. This treatment is currently undergoing a Phase 2 multicohort trial across the United States and over ten other countries.