Site Editor
Jeremy S. Abramson, MD, MMSc
Jeremy S. Abramson, MD, MMSc
Posted: Thursday, February 20, 2025
Alexey Danilov, MD, PhD, of City of Hope, Duarte, California, and colleagues presented data from the fully enrolled chronic lymphocytic leukemia (CLL) expansion cohort and the first data from a cycle 1 optimization cohort of the EPCORE CLL-1 trial at the 2024 American Society of Hematology (ASH) Annual Meeting & Exposition. These early findings with the CD3 × CD20 bispecific antibody epcoritamab in patients with relapsed or refractory CLL support its continued evaluation, according to the investigators.
“Single-agent epcoritamab led to encouraging complete response and undetectable minimal residual disease rates in heavily pretreated relapsed or refractory CLL, regardless of high-risk features,” they stated. “Immune-related toxicities were markedly improved with an adapted step-up dosing schedule.”
EPCORE CLL-1 is a multicenter, open-label, phase Ib/II trial evaluating the use of epcoritamab in patients with CD20-positive relapsed or refractory CLL or small lymphocytic lymphoma who have undergone at least two prior systemic therapies, including Bruton’s tyrosine kinase inhibitors. As of May 2024, the study included 40 patients. Many patients had high-risk disease characteristics, such as TP53 aberrations (63%) and unmutated IGHV (70%).
Among patients in the expansion cohort, epcoritamab demonstrated an overall response rate of 61%, with a complete response rate of 39%. Patients with TP53 aberrations achieved an overall response rate of 67%, with a complete response rate of 33%; those with unmutated IGHV had an overall response rate of 63% and a complete response rate of 44%.
Minimal (measurable) residual disease (MRD) analysis in the expansion cohort showed that 75% of evaluable responders achieved undetectable MRD at the standard 10⁻⁴ threshold. A total of 67% achieved undetectable MRD at the more stringent 10⁻⁶ threshold.
The most frequently reported nonhematologic treatment-emergent adverse events in the expansion cohort included cytokine-release syndrome (96%), diarrhea (48%), peripheral edema (48%), and fatigue (43%). Hematologic toxicities such as anemia (65%) and thrombocytopenia (65%) were also reported. Of note, the optimization cohort had a marked reduction in the severity of cytokine-release syndrome.
Disclosure: For full disclosures of the study authors, visit ash.confex.com.
2024 ASH Annual Meeting & Exposition
