SELLAS Life Sciences Group, Inc. recently disclosed the preliminary outcomes from the Phase 2a trial of their drug SLS009, a highly selective CDK9 inhibitor, used in treating recurrent or hard-to-treat acute myeloid leukemia. They have also successfully submitted a provisional patent application encompassing the ASXL1 mutation and SLS009, along with all CDK9 inhibitor drugs. As of April 19, the data cutoff showed a significant 57% overall response rate, considerably exceeding the anticipated 20% rate utilizing the optimal dose regimen of 30 mg biweekly.
SELLAS has plans to begin talks with the Food and Drug Administration (FDA) regarding the potential for a fast-tracked approval process for SLS009. This will apply not just for the molecularly defined ASXL1 acute myeloid leukemia patients who are either recurrent or hard-to-treat, but also for patients exhibiting this mutation in various other cases.
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