Apollomics Announces Top-line Results for Phase 3 Trial of Uproleselan in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Apollomics Inc. recently announced the results from its Phase 3 bridging trial of uproleselan in China in patients with relapsed or refractory acute myeloid leukemia. The trial did not demonstrate favorable benefit for uproleselan.

The Phase 3 trial was a randomized, double-blinded bridging trial to evaluate the safety and efficacy of uproleselan administered with chemotherapy versus chemotherapy alone in patients with relapsed or refractory acute myeloid leukemia. The primary endpoint was comparing overall survival (OS) in the uproleselan treatment arm versus the control arm. A total of 140 subjects were enrolled in the Phase 3 trial and randomized 1:1 to receive either uproleselan with chemotherapy (n=69) or chemotherapy alone (n=71). The median OS in the uproleselan arm was 9.3 months (95% CI 6.1 – 16.0 months) versus 14.3 months (95% CI 6.2 – NA months) in the chemotherapy-only arm (p=0.48). Addition of uproleselan to chemotherapy was generally well tolerated, with a similar safety profile to the control arm. The incidence of serious adverse events was 43% in the uproleselan arm versus 39% in the chemotherapy-only arm. The most common serious adverse events in the uproleselan arm were decreased platelet count, infectious pneumonia, and sepsis.

“While we are disappointed that uproleselan did not show a clinical benefit, the results were expected given that the global Phase 3 trial of uproleselan in a similar patient population by our partner, Glycomimetics, did not meet its primary endpoint earlier this year. Our regulatory and commercial strategy in China has always required a positive global Phase 3 trial, and therefore we are currently wrapping up this program,” said Guo-Liang Yu, PhD, Chairman and CEO of Apollomics. “We extend our thanks and gratitude to all the patients and their families, investigators and clinical team that supported the trial.”

In August 2024, Apollomics announced the write-down of the intangible asset related to the upfront payment for the uproleselan program. Apollomics is concluding the clinical trial and expects future expenses for the uproleselan program to be less than $500,000.

The company intends to submit the full results of this trial for presentation at a future medical conference.

Apollomics Inc. is an innovative clinical-stage biopharmaceutical company focused on the discovery and development of oncology therapies with the potential to be combined with other treatment options to harness the immune system and target specific molecular pathways to inhibit cancer. Apollomics’ lead program is vebreltinib (APL-101), a potent, selective c-Met inhibitor for the treatment of non-small cell lung cancer and other advanced tumors with c-Met alterations, which is currently in a Phase 2 multicohort clinical trial in the United States and over 10 other countries. For more information, visit www.apollomicsinc.com.