Posted: Friday, July 22, 2022
Jeff Porter Sharman, MD, of US Oncology Network, Woodlands, Texas, and colleagues reported on the 5-year follow-up data from the ELEVATE-TN trial. They found the efficacy and safety of the combination of acalabrutinib and obinutuzumab as well as acalabrutinib monotherapy were maintained in patients with treatment-naive chronic lymphocytic leukemia (CLL). In fact overall survival was significantly longer with the acalabrutinib-based therapy compared with obinutuzumab plus chlorambucil. These findings were presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 7539).
The 5-year follow-up study randomly assigned patients to receive acalabrutinib plus obinutuzumab, acalabrutinib monotherapy, or obinutuzumab plus chlorambucil. Patients whose disease progressed on obinutuzumab/chlorambucil treatment could cross over to acalabrutinib monotherapy.
The study included 535 patients: 179 received acalabrutinib/obinutuzumab, 179 received acalabrutinib monotherapy, and 177 received obinutuzumab/chlorambucil. The median age of patients was 70.
The median progression-free survival was not reached for acalabrutinib/obinutuzumab or acalabrutinib at 58.2 months of follow-up. The estimated 60-month progression-free survival rates were 84% for acalabrutinib/obinutuzumab, 72% for acalabrutinib monotherapy, and 21% for obinutuzumab/chlorambucil. The median overall survival was not reached in any treatment arm. However, the overall survival rate was significantly longer with acalabrutinib/obinutuzumab than with obinutuzumab/chlorambucil (P = .0474). The estimated 60-month overall survival rates were 90% with acalabrutinib/obinutuzumab, 84% with acalabrutinib monotherapy, and 82% with obinutuzumab/chlorambucil. The overall response rate was significantly higher with acalabrutinib/obinutuzumab (P <.0001) and acalabrutinib monotherapy (P =.0499) than with obinutuzumab/chlorambucil. The complete response/complete response with incomplete hematologic recovery rates were higher with acalabrutinib/obinutuzumab (29%/3%) versus obinutuzumab/chlorambucil (13%/1%).
Treatment was ongoing in 65% of patients given acalabrutinib/obinutuzumab and 60% of patients given acalabrutinib. The most common reasons for treatment discontinuation were adverse events (17% [acalabrutinib/obinutuzumab], 16% [acalabrutinib monotherapy], 14% [obinutuzumab/chlorambucil]) and progressive disease (6%, 10%, 2%, respectively). Crossover from obinutuzumab/chlorambucil to acalabrutinib treatment occurred in 72 patients (41%). Of the 72 patients, 25% discontinued treatment with acalabrutinib.
Disclosures: For full disclosures of the study authors, visit coi.asco.org.