First Patient Receives Investigational Cancer Drug-Combination for Relapsed/Refractory Acute Myeloid Leukemia


Adding the investigational cancer drug lanraplenib to Xospata, if found to be effective, may broaden treatment options for patients with relapsed/refractory FLT3-mutated acute myeloid leukemia.

The first patient in a phase 1b/2 clinical trial received treatment with lanraplenib plus Xospata (gilteritinib), according to a press release from the targeted therapy’s manufacturer, Kronos Bio.

Lanraplenib, a spleen tyrosine kinase inhibitor, is being developed for the treatment of patients with relapsed/refractory FLT3-mutated acute myeloid leukemia. This genetic mutation is found in approximately one-third of patients with acute myeloid leukemia, according to the release.

“The initiation of this study is an important first step as we advance lanraplenib for patients with certain genetically defined types of (acute myeloid leukemia),” said Dr. Jorge DiMartino, chief medical officer and executive vice president of clinical development at Kronos Bio, in the release. “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 (acute myeloid leukemia). Today’s announcement represents important progress toward that goal.”

Researchers conducting this clinical trial are assessing antileukemic, pharmacokinetic and safety of lanraplenib plus Xospata in patients with relapsed/refractory FLT3-mutated acute myeloid leukemia. The trial will also focus on the FLT3 measurable residual disease (a very small number of cancer cells in the body during or after treatment) negativity rate in patients with a complete response (disappearance of all signs of cancer from treatment), in addition to potential biomarkers that may align with clinical outcomes, according to the release.

The early-phase clinical trial is expected to comprise 55 adults with acute myeloid leukemia who have received at least one prior treatment.

The trial is still recruiting patients across several treatment centers in the United States. Enrolled patients must have adequate liver and kidney function. Additionally, patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 and 2. Of note, the ECOG performance status score is used to identify a patient’s level of functioning in terms of their ability to care for themselves, as well as perform daily activities such as working and walking. An ECOG score of 2 or less indicates that a person is capable of caring for themselves in some capacity as well as working in some instances.

Once researchers determine the recommended dose of lanraplenib plus Xospata, another stage of the clinical trial will be added to evaluate the safety and antileukemic activity of lanraplenib.

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