On May 18, 2017 GlycoMimetics, Inc. (NASDAQ: GLYC) reported the release of abstracts containing new data from the ongoing Phase 2 clinical trial of its product candidate GMI-1271, an E-selectin antagonist, in patients with acute myeloid leukemia (AML) (Press release, GlycoMimetics, MAY 18, 2017, View Source [SID1234519253]). The data will be presented at the June annual meetings of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and the European Hematology Association (EHA) (Free EHA Whitepaper). The data released by ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper), which reflect a late-January analysis, will be updated in posters presented at both meetings.
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In the ongoing Phase 2 trial, AML patients treated with GMI-1271, combined with chemotherapy, continue to experience higher-than-expected remission rates and lower-than-expected induction-related mortality rates in both arms of the trial. In addition, researchers have observed that baseline expression of the E-selectin ligand biomarker on leukemia cells was predictive of clinical response and tied to greater likelihood of achieving remission in the cohort of AML patients with relapsed/refractory disease, which supports the mechanism of action of GMI-1271. Treatment with GMI-1271 continues to be well tolerated, with no obvious incremental toxicity observed when GMI-1271 is added to chemotherapy.
According to Helen Thackray, MD, Chief Medical Officer, "The data has consistently shown good tolerability and high remission rates as well as lower than expected 30- and 60-day mortality rates in early evaluations of patients. We are increasingly confident that our investigational drug, GMI-1271, may play a role in addressing unmet needs in this cancer. It is particularly noteworthy to see in the relapsed/refractory cohort that patients who have higher levels of the E-selectin ligand biomarker on their leukemic blasts appear to be more likely to achieve remission of their disease. This observation builds directly on what we and others have reported in the preclinical and clinical settings about the key role E-selectin plays in many forms of cancer, including AML. Importantly, this provides what we believe is the first direct clinical evidence of the potential benefit of targeting of E-selectin in this difficult-to-treat population of AML patients."
Relapsed or Refractory Disease Arm: Abstract Data
Consistent with GlycoMimetics’ prior published research, the addition of GMI-1271 to mitoxantrone, etoposide and cytarabine (MEC) chemotherapy has been well-tolerated, with patients achieving a high overall response rate (ORR), low induction mortality, and promising initial survival outcomes. The data show that baseline expression of the E-selectin ligand biomarker was predictive of response. GlycoMimetics believes these results are better than what would be expected in this population, based on published historical controls in similar patients.
Highlights of the data reported in the published abstract include:
47 patients were enrolled.
30- and 60-day mortality were 0 and 7%, respectively.
ORR was 21/42 evaluable (50%).
Median Overall Survival in the Phase 1 portion was 7.6 months.
The median E-selectin ligand binding at baseline was 35% of blasts (range, 1-75%) and, importantly, was higher in those achieving remission.
The data from the ongoing Phase 2 trial were submitted to the U.S. Food and Drug Administration (FDA). As announced yesterday, GMI-1271 was granted Breakthrough Therapy designation from the FDA for the treatment of adult AML patients with relapsed/refractory disease. The FDA had previously granted Orphan Drug designation and Fast Track Status for GMI-1271 for the treatment of AML.
Newly Diagnosed, Treatment-Naïve, Elderly Arm: Abstract Data
In the published abstract, data reflects 17 of 24 enrolled and evaluable elderly patients. Highlights from the abstract include:
The remission rate (CR/CRi) was 12/17 (71%).
CR/CRi rate was 75% for patients with de novo disease and 67% for patients with secondary AML.
GlycoMimetics noted that the safety profile of the investigational drug, GMI-1271, in combination with chemotherapy is encouraging. Outcomes for elderly patients with AML remain poor, and tolerability of treatments is a key concern.