GlycoMimetics Announces New Uproleselan Clinical Data in Both Frontline Unfit and Treated Secondary Acute Myeloid Leukemia presented at ASH Annual Meeting
“We are excited to share initial results from these two investigator-sponsored trials of uproleselan. The studies describe safety and preliminary efficacy in frontline unfit and treated secondary AML populations not previously studied with this novel investigational agent,” said
Uproleselan Added to Cladribine Plus Low Dose Cytarabine (LDAC) in Patients with Treated Secondary Acute Myeloid Leukemia (TS-AML)
This Phase Ib/II clinical trial evaluates safety, tolerability, and preliminary efficacy of uproleselan added to cladribine and low-dose cytarabine (LDAC) in patients with treated secondary AML. A majority of 15 patients enrolled were male (n=10) with ECOG status of less than 2 (ECOG 0=1; 1=10; 2=4). Median age was 71 years. Preliminary results from 12 evaluable patients at 3.3 months follow-up found cladribine and LDAC combined with uproleselan generated few treatment-related adverse events. The combination produced an overall response rate of 62% in a very high-risk population with expected median survival below 5 months. Disease responses were seen irrespective of previous hypomethylating agents and Venetoclax exposure. Enrollment in the study is ongoing.
A Phase I Study of Uproleselan Combined with Azacitidine and Venetoclax for the Treatment of Older or Unfit Patients with Treatment Naïve Acute Myeloid Leukemia
This Phase I study is evaluating the safety, tolerability, and preliminary efficacy of uproleselan in combination with azacitidine (Aza) and Venetoclax (Ven) in patients with untreated AML who were unfit for intensive chemotherapy. The majority of the 8 patients enrolled were female (n=6) with a median age of 78. Four patients had secondary AML, including 3 with therapy-related AML, and 75% had ELN adverse risk cytogenetics. Preliminary results showed that uproleselan with Aza/Ven did not lead to any dose-limited toxicities. The most common Grade 3-4 adverse events and serious adverse events were hematologic in nature. Dose modifications and/or cycle delays were common. In this study the combination produced promising preliminary results, with all 8 patients having a MLFS+ response. Five patients (63%) achieved CR and one patient achieved CRi, for a total CR/CRi rate of 75%, and two patients achieved MLFS. Four of the CR/CRi responses were MFC MRD-ve, for an overall MRD-ve CR/CRi rate of 50% and 67% among the CR/CRi responders. Enrollment is ongoing with current plans to add two additional sites to the study.
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