Three FCS Oncologists Co-Author Integrated Safety Analysis of Umbralisib in Lymphoid Malignancies

Fort Myers, Fla., Oct. 14, 2021 – Three medical oncologists at Florida Cancer Specialists & Research Institute (FCS) are co-authors on a new integrated safety analysis of umbralisib, used to treat lymphoid malignancies. FCS Director of Clinical Research Gustavo Fonseca, MD, FACP, Director of Drug Development Manish Patel, MD and James Reeves, MD, a member of the FCS clinical research team, participated in the study entitled “Integrated safety analysis of umbralisib, a dual PI3Kδ/CK1ε inhibitor, in relapsed/refractory lymphoid malignancies,” which was recently published online in Blood Advances.

Florida Cancer Specialists & Research Institute is a strategic partner of Sarah Cannon Research Institute, one of the leading clinical trial organizations in the world, and was heavily involved in the development of umbralisib, beginning with the initial Phase I trial in Sarasota at the FCS Drug Development Unit (DDU) and continuing to the later phase trials that have taken place throughout the practice’s network over several years.

As stated in the study, “Phosphoinositide 3-kinase-delta (PI3Kδ) inhibitors are active in lymphoid malignancies, though associated toxicities can limit their use. Umbralisib is a dual inhibitor of PI3Kδ and casein kinase-1ε (CK1ε),” which distinguishes it from other lymphoma treatments. The drug received accelerated approval from the Food and Drug Administration (FDA) in February 2021 for the treatment of relapsing and refractory marginal zone lymphoma (MZL) and follicular lymphoma (FL) in adults.*

Drs. Fonseca, Patel, Reeves and their co-authors analyzed comprehensive data on the toxicity of umbralisib from four phase 1 and 2 studies. These studies included 371 adult patients with relapsed/refractory non-Hodgkin lymphoma (follicular lymphoma); marginal zone lymphoma; diffuse large B-cell lymphoma/mantle cell lymphoma and chronic lymphocytic leukemia (CLL).

Low rates of immune-mediated toxicities were observed with umbralisib and no cumulative toxicities were reported. The analysis concluded, “The favorable long-term tolerability profile and low rates of immune-mediated toxicities support the potential use of umbralisib for the benefit of a broad population of patients with lymphoid malignancies.”

To access the PDF: https://doi.org/10.1182/bloodadvances.2021005132

*Additional resource – Food and Drug Administration: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-umbralisib-marginal-zone-lymphoma-and-follicular-lymphoma