After unveiling updated results from a trial evaluating GMI-1271 in relapsed or refractory acute myeloid leukemia (AML), GlycoMimetics (NASDAQ: GLYC) shares are surging 24.3% as of noon EST Tuesday.
In June, GlycoMimetics provided results for GMI-1271 at the American Society of Clinical Oncology (ASCO) annual meeting. At the time, results from this phase 1/2 study failed to impress, causing shares to sell-off.
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Today, updated GMI-1271 data is having the opposite effect on investors.
In June, the overall response rate in 54 evaluable AML patients was 41% and median overall survival from the phase 1 portion of the study was 7.6 months. Also, the overall response rate was 68% in 25 newly diagnosed AML patients over age 60. Previously, the overall response rate in 42 evaluable patients was 50%, so the declining ORR weighed down optimism.
News today is that the clinical remission rate was 43% in 54 patients at a median follow-up of 6.6 months. Median overall survival was 9.4 months while median duration of remission was 11.1 months. This compares favorably to a historical median overall survival of up to 5.4 months for similar patient populations. In the 25 older patients with newly diagnosed AML, the clinical remission rate was 68% at a median follow-up of 10.5 months. The median overall survival was 15.8 months and the median duration of remission was 14.8 months.
Overall, there doesn't appear to be any unforeseen safety concerns, so the company plans to begin a phase 3 trial in 2018.
GM-1271 disrupts pathways of tumor resistance in a manner that makes chemotherapy more effective and trials so far suggest that it could one day become another tool in oncologists' toolboxes. GlycoMimetics will hold a briefing for investors to review the GMI-1271 program on Dec. 19, at 7:30 a.m. EST, so investors will want to pay attention to how the market reacts to that discussion next week.
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