Apollomics Completes Phase 3 Enrollment for Uproleselan in Chinese AML Patients

Apollomics Inc., a biopharmaceutical firm focused on clinical-stage development, has announced the successful completion of patient enrollment for its Phase 3 bridging trial evaluating uproleselan (APL-106) for treating adult patients with relapsed or refractory acute myeloid leukemia (AML). Uproleselan is an investigational E-selectin antagonist intended to be used alongside standard chemotherapy.

The study, a randomized controlled trial conducted in China, involved 140 adult patients across 20 locations in Greater China. These participants, all suffering from either primary refractory AML or relapsed AML, were assigned to receive either a combination of uproleselan and chemotherapy or a placebo plus chemotherapy. Apollomics obtained the rights to develop, produce, and market uproleselan in Greater China through a licensing agreement with GlycoMimetics.

Dr. Jianxiang Wang of the Chinese Academy of Medical Sciences and Peking Union Medical College noted that uproleselan, the first of its kind, could revolutionize the treatment approach for relapsed and refractory AML patients. AML remains an aggressive blood cancer with poor prognosis, especially in relapsed or refractory cases. In China alone, nearly 40,000 new AML cases are diagnosed each year, highlighting the urgent need for effective treatments. Guo-Liang Yu, Chairman and CEO of Apollomics, emphasized the potential of uproleselan to address chemoresistance and improve patient outcomes. He also expressed gratitude to all parties involved in achieving this important milestone.

The primary endpoint of the Phase 3 study is overall survival, with secondary endpoints including remission rates, remission duration, and the incidence of oral mucositis, a common chemotherapy-related side effect. Detailed information about the clinical trial is available on clinicaltrials.gov under the identifier NCT05054543.

Uproleselan, developed initially by GlycoMimetics, is currently undergoing extensive clinical evaluation, including a late-stage Phase 3 trial. It has received Breakthrough Therapy and Fast Track designations from the U.S. FDA and a Breakthrough Therapy designation from the Chinese National Medical Products Administration for adult AML patients with relapsed or refractory conditions. The drug operates by inhibiting E-selectin, a molecule expressed on blood vessel surfaces that facilitates leukemic cell survival via NF-kB signaling, thus potentially overcoming chemoresistance.

Apollomics Inc. is a cutting-edge biopharmaceutical company dedicated to the discovery and development of oncology treatments that work by mobilizing the immune system and targeting specific molecular pathways. Currently, the company's pipeline includes nine drug candidates, with six in the clinical stage. The lead candidates include vebreltinib (APL-101) and uproleselan (APL-106), both of which target different aspects of cancer treatment. Vebreltinib is a selective c-Met inhibitor aimed at treating non-small cell lung cancer and other tumors with c-Met alterations, while uproleselan is designed to be used in conjunction with standard chemotherapy for acute myeloid leukemia.

This overview highlights Apollomics' commitment to advancing cancer therapy through innovative drug development and rigorous clinical testing, positioning the company at the forefront of oncological research and treatment.