ASCO 2021: 4-Year Update of ELEVATE-TN Trial of Acalabrutinib Regimens in CLL
Posted: Monday, June 21, 2021
During the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, Jeff Porter Sharman, MD, of the Willamette Valley Cancer Institute and US Oncology Research Center, Eugene, Oregon, and colleagues shared the 4-year update of the ELEVATE-TN trial of acalabrutinib regimens in patients with treatment-naive chronic lymphocytic leukemia (CLL) (Abstract 7509). They announced that the efficacy and safety of the combination of the kinase inhibitor acalabrutinib plus the monoclonal antibody obinutuzumab as well as acalabrutinib monotherapy were maintained since the interim analysis, with increases in complete response rates with both regimens (from 21% to 27% and from 7% to 11%, respectively).
The investigators focused on 535 patients with treatment-naive CLL who were randomly assigned 1:1:1 to receive obinutuzumab with either chlorambucil (n = 177) or acalabrutinib (n = 179) or acalabrutinib alone (n = 179). Patients who experienced disease progression on obinutuzumab plus chlorambucil were allowed to crossover to acalabrutinib monotherapy.
At a median follow-up of 46.9 months, the median progression-free survival was not reached for those treated with acalabrutinib plus obinutuzumab or acalabrutinib alone. However, patients given obinutuzumab plus chlorambucil had a progression-free survival of 27.8 months.
The estimated 48-month progression-free survival rates for acalabrutinib plus obinutuzumab, acalabrutinib alone, and obinutuzumab plus chlorambucil were 87%, 78%, and 25%, respectively; overall survival rates were 93%, 88%, and 88%. The objective response rate was the highest in the acalabrutinib-plus-obinutuzumab group (96.1%), followed by acalabrutinib alone (89.9%) and obinutuzumab plus chlorambucil (82.5%). Patients who received acalabrutinib plus obinutuzumab had the highest rates of complete response/complete response with incomplete hematologic recovery compared with those given obinutuzumab plus chlorambucil and acalabrutinib alone.
The most common adverse events with acalabrutinib plus obinutuzumab and acalabrutinib alone were bleeding, diarrhea, and headache. As for the combination of obintuzumab and chlorambucil, the most common adverse events were neutropenia, infusion-related reactions, and nausea. Adverse events influenced treatment discontinuation in 12.8%, 12.3%, and 14.7% of patients given acalabrutinib plus obinutuzumab, acalabrutinib alone, and obinutuzumab plus chlorambucil, respectively.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.