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Kronos Bio Gets FDA OK to Begin Phase I/II Trials of SYK Inhibitor in AML

NEW YORK – Kronos Bio on Tuesday said that the US Food and Drug Administration has cleared its investigational new drug application for lanraplenib, allowing it to begin studying the SYK inhibitor in combination with gilteritinib (Astellas' Xospata) in FLT3-mutated, relapsed or refractory acute myeloid leukemia patients.

The San Mateo, California-headquartered drugmaker will begin the Phase I/II lanraplenib-gilteritinib combination trial in Q4 this year. In this study, researchers will initially explore the safety, pharmacokinetics, and preliminary activity of increasing once-daily doses of lanraplenib in combination with gilteritinib. They will also track patients for FLT3 measurable residual disease negativity to gauge if they are having complete responses to the combination and look for biomarkers predictive of response.

The first data from this phase of the study is expected in the second half of 2022. Once the recommended dose is set, investigators will enroll 30 patients in the second phase of the trial to further measure the activity of the drug. These data are expected in the second half of 2023.

Lanraplenib has shown acceptable safety in studies involving more than 250 healthy volunteers and patients with autoimmune diseases. Kronos' plan is to explore the activity of the drug for progressive AML in extended dosing regimens in combination with gilteritinib and venetoclax (AbbVie/Genentech's Venclexta) plus the chemotherapy azacitidine.

The company will begin a second Phase I/II trial in the first half of next year, exploring lanraplenib's activity in combination with venetoclax and azacitidine in patients with newly diagnosed AML with NPM1 and FLT3 mutations. Patients must be at least 75 years old and cannot be eligible for intensive induction chemo. The company expects data readouts from this trial in 2023 and 2024.

In addition to lanraplenib, Kronos has another SYK inhibitor in its pipeline, entospletinib, which is slated to enter Phase III trials for newly diagnosed AML patients with NPM1 mutations. "We believe this precision oncology approach [with these SYK inhibitors] will allow us to systematically address patients with genetic mutations present in more than two-thirds of the AML patient population," Jorge DiMartino, Kronos' chief medical officer, said in a statement.