Cerdulatinib for the treatment of b-cell malignancies
Inventors
Pandey, Anjali • Coffey, Gregory • Leeds, Janet
Assignees
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Publication Number
US-12350269-B2
Publication Date
2025-07-08
Expiration Date
Abstract
Provided herein are compositions and methods for treating a relapsed or refractory hematologic cancer in a human patient in need thereof. The methods entail administering to the patient a daily dose of about 10 mg to about 75 mg of cerdulatinib or a pharmaceutically acceptable salt thereof, wherein the patients suffer one or more of a B-cell malignancy, chronic lymphocytic leukemia (CLL), follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL) or other transformed FL and/or have relapsed or not responded to a prior chemotherapy.
Core Innovation
The disclosed invention relates to compositions and methods using cerdulatinib for treating relapsed/refractory B-cell malignancies in a human patient. Cerdulatinib is described as a small-molecule ATP-competitive reversible inhibitor of SYK and JAK, and its therapeutic effects are linked to inhibition of B-cell antigen receptor (BCR)/SYK signaling and JAK/STAT pathway signaling.
The problem addressed is the need for treating relapsed or refractory B-cell malignancies, including follicular lymphoma and transformed follicular lymphoma. The partial content states that patient selection and disease context can include eligibility factors associated with poor prognosis and relapse or drug resistance, including specified relapse- and resistance-linked mutations and markers such as unmutated IGHV, high CD49d, and ZAP-70.
The partial content also describes pharmacodynamic and pharmacokinetic support for the approach, including ex vivo inhibition of BCR/SYK signaling and cytokine JAK/STAT signaling, apoptosis and cell-cycle arrest in DLBCL cell lines, and apoptosis in primary CLL with subgroup-dependent potency. It additionally describes Phase 1 PK/PD findings showing SYK/JAK pathway inhibition and reduction of serum inflammation markers correlated with tumor response, supporting use of cerdulatinib monotherapy in the described patient populations.
Claims Coverage
The partial content provides one independent claim focused on treating follicular lymphoma with cerdulatinib as monotherapy using specified dosing regimens and administration schedules. Dependent coverage refines the treated follicular lymphoma state and patient eligibility using disease-state conditions and specific relapse- or drug-resistance-associated mutations.
Monotherapy treating follicular lymphoma with twice-daily or once-daily cerdulatinib dosing
A method of treating a follicular lymphoma in a human patient in need thereof by administering about 15 mg or about 30 mg of cerdulatinib or a pharmaceutically acceptable salt thereof twice daily, or about 30 mg of cerdulatinib or a pharmaceutically acceptable salt thereof once daily, wherein cerdulatinib is administered as monotherapy and not administered in combination with another anticancer drug therapy.
Across the independent claim, the core inventive coverage is cerdulatinib as monotherapy for treating follicular lymphoma with specified once-daily or twice-daily dosing and without combination anticancer drug therapy. Dependent aspects further limit the patient and disease context using relapsed/refractory or transformed follicular lymphoma status and specific relapse- or drug-resistance-associated mutations.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Treating a follicular lymphoma in a human patient using cerdulatinib monotherapy administered about 15 mg or about 30 mg twice daily or about 30 mg once daily.
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