The phase 2/3 PREACH-M trial is evaluating the addition of lenzilumab, an anti-granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody, to the current standard of care for the treatment of newly-diagnosed chronic myelomonocytic leukemia (CMML).
Early data from the trial suggest promising objective responses, according to a poster presented at the AACR Annual Meeting 2023.
The open-label, nonrandomized trial will treat 72 adults with newly-diagnosed CMML with TET2 or RAS pathway mutations with lenzilumab plus the standard-of-care azacitidine. For patients with RAS pathway mutations, lenzilumab and azacitidinewill be administered for 24 cycles. Patients with TET2 mutations only will also receive sodium ascorbate.
The primary endpoint of the study is the proportion of patients who achieve a complete or partial response within the first 12 cycles of treatment.
Overall and progression-free survival at 2 years are secondary endpoints. Other secondary endpoints include proportion of patients with clinical benefit at any time during 24 cycles, physical and functional capacity, social well-being, quality of life, and safety.
Of the 72 patients planned for enrollment, 8 have received treatment (as of December 31, 2022) and 6 were evaluable for assessment. An objective response was observed in all patients, 2 of whom had high-risk disease based on molecular profiling.
There were 10 grade 3-4 serious adverse events, including 2 that were deemed possibly related to lenzilumab.
Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, or device companies. Please see the original reference for a full list of disclosures.
Hiwase D, Ross D, Lane S, et al. A phase 2/3, multicenter trial of lenzilumab and azacitidine in chronic myelomonocytic leukemia: The PREACH-M trial. AACR 2023; April 14-19, 2023. Abstract CT085/13.