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CMML is an aggressive, poorly understood cancer; approximately 20% of patients survive three years from diagnosis
Eleven subjects dosed with lenzilumab and with current standard of care, azacitidine
Six evaluable subjects, including those with high risk CMML, demonstrated clinical benefit at three months follow-up
Lenzilumab appears to be well-tolerated
Short Hills, New Jersey and Adelaide, South Australia--(Newsfile Corp. - April 14, 2023) - Humanigen, Inc. (NASDAQ:HGEN), Humanigen Australia Pty Ltd, (Humanigen) and the South Australian Health and Medical Research Institute (SAHMRI) today presented (poster CT085/13); the design and baseline results of the Precision Approach to Chronic Myelomonocytic Leukemia (PREACH-M) study of lenzilumab in chronic myelomonocytic leukemia (CMML), at the 2023 annual meeting of the American Association of Cancer Research being held in Orlando, FL April 14-19. PREACH-M is currently treating 11 intermediate and high risk CMML subjects (five male, six female; mean age 68 years) with lenzilumab, a granulocyte-macrophage colony-stimulating factor (GM-CSF) neutralizing antibody, and azacitidine, the current standard of care for CMML. As of December 31, 2022, six subjects were evaluable based on at least three months of follow-up and all demonstrated clinical benefit. Ten grade 3/4 Serious Adverse Events were observed, of which two were assessed by the investigator as possibly related to lenzilumab.
CMML remains a disease with high unmet medical need and there have been no new therapeutic agents with a novel mechanism of action for patients with high-risk CMML in the last 30 years.1Treatment options for these patients are limited to blood transfusions, hydroxyurea and supportive care alongside the current standard of care, which includes hypomethylating agents such as azacytidine and decitabine with limited response rates of 7-18%2,3,4 and no proven increase in overall survival.
"GM-CSF is a cytokine that helps make white blood cells in the body and promotes myeloid cell development and maturation, playing a major role in the development of CMML.5The clinical benefits of GM-CSF neutralization in life-threatening conditions such as CMML may be highlighted by these early results," said Cameron Durrant, MD, MBA, Chairman and CEO, Humanigen. "PREACH-M has brought together experts from around the world and enabled Humanigen and its clinical partners to quickly obtain important data that may help us address a critical unmet need in oncology. We believe that the results observed to date have the potential to qualify lenzilumab for expedited regulatory pathways."
"PREACH-M is enrolling intermediate and high risk CMML patients with TET2 and RAS pathway mutations who would ordinarily be treated only with azacitidine or another hypomethylating agent, the standard of care for the past thirty years. These patients have significant hematologic indices and constitutional symptoms of CMML," said Associate Professor Daniel Thomas, principal investigator of the PREACH-M study and Program Leader for Blood Cancers at SAHMRI and Associate Professor of Medicine at the University of Adelaide. "The current early data from PREACH-M suggests promise in improving treatment response rates in CMML through GM-CSF neutralization with lenzilumab. Patients undergoing treatment in PREACH-M also appear to tolerate lenzilumab well."
Treatment with lenzilumab and azacitidine led to rapid clinical response in all evaluable patients. Three high-risk patients, as defined by CMML-specific prognostic scoring system-Molecular (CPSS-Mol)6 achieved clinical benefits, as defined by the Savona criteria7 for myelodysplastic/myeloproliferative neoplasms (MDS/MPN). Quality of life is also being measured.
Posted In: HGEN
