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.
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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.
Reference
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.
