A Kura Oncology and Kyowa Kirin-partnered drug vying to become the first FDA-approved treatment for cases of acute myeloid leukemia (AML) carrying a particular genetic signature will have its regulatory review supported by clinical data showing the therapy achieved statistically significant improvement in signs and symptoms of the disease. But the companies held back on revealing details of the results until the full presentation of the data this week during the annual meeting of the American Society of Clinical Oncology in Chicago.
The Kura drug, ziftomenib, is part of a new class of therapies designed to block menin, a protein that supports cancer growth in leukemias. Kura’s oral small molecule is specifically designed to address leukemias characterized by mutations to the NPM1 gene,