NEW YORK – Kronos Bio said Monday that the first patient with advanced FLT3-mutated acute myeloid leukemia has received the combination of its SYK inhibitor lanraplenib and Astellas' Xospata (gilteritinib) in a Phase Ib/II trial.
In the first stage of the trial, patients with relapsed or refractory FLT3-mutated AML will receive escalating doses of lanraplenib with standard-dose Xospata to assess safety, pharmacokinetics, and anti-leukemic activity. That will be followed by an expansion stage to further evaluate the safety and efficacy of the drug combination.
"The initiation of this study is an important first step as we advance lanraplenib for patients with certain genetically defined types of AML," Jorge DiMartino, Kronos Bio chief medical officer and executive VP, said in a statement. "Our long-term vision is to develop lanraplenib as a cornerstone of targeted regimens for these patients, allowing us to potentially reach as many as two-thirds of patients with AML."
Lanraplenib has shown activity against NPM1-mutated and FLT3-mutated AML. In prior studies of the drug in patients with autoimmune diseases by Gilead, lanraplenib had an acceptable safety profile.
San Mateo, California-based Kronos is developing another SYK inhibitor, entospletinib, for patients with NPM1-mutated AML. It began a Phase III trial in December 2021 in patients with newly diagnosed disease, who are receiving entospletinib plus chemotherapy or chemotherapy alone. Data from that trial is anticipated in the second half of 2023.
Lanraplenib and entospletinib came to Kronos in 2020, when it purchased Gilead Sciences' SYK inhibitor portfolio. Gilead is entitled to regulatory and commercial milestone payments and royalties on future sales of products developed from the acquired programs.