Updated clinical data from Ph 1/2 KOMET-001 trial of ziftomenib in patients with heavily pretreated and co-mutated R/R NPM1-mutant AML announced

“Our goal with our ziftomenib program is to transform the standard of care for patients with acute leukemias,” said Stephen Dale, M.D., Chief Medical Officer of Kura Oncology, “and we are delighted to share new clinical and preclinical data that we believe further demonstrate its potential best-in-class product profile. The emerging data for ziftomenib include: high clinical activity in relapsed/refractory NPM1-mutant AML patients, including 35% achieving durable complete remissions (CR) with maintained full count recovery on ziftomenib monotherapy; a lower frequency of MEN1 resistance mutations; a favorable safety and tolerability profile; strong evidence of mechanistic synergy with standards of care such as venetoclax and FLT3 inhibitors; and convenient once-daily, oral dosing and optimal pharmaceutical properties for combination. We believe ziftomenib has the ideal properties to become a cornerstone of therapy across the continuum of treatment, and we intend to build on the growing momentum as we continue to execute on our registration-enabling study in NPM1-mutant AML and move rapidly into combinations.”