Dr Dorritie on Acalabrutinib With/Without Obinutuzumab in Treatment-Naive CLL

Kathleen A. Dorritie, MD, hematologist/medical oncologist at the University of Pittsburgh Medical Center’s Hillman Cancer Center and assistant professor of medicine in the Division of Oncology, Department of Medicine, University of Pittsburgh, discusses the clinical implications of the 6-year follow-up data from the phase 3 ELEVATE-TN study (NCT02475681) evaluating acalabrutinib (Calquence) with or without obinutuzumab (Gazyva) vs obinutuzumab plus chlorambucil in patients with treatment-naive chronic lymphocytic leukemia (CLL).

Six-year follow up data from ELEVATE-TN demonstrated that both acalabrutinib-containing regimens demonstrated an improvement in progression-free survival (PFS) compared with the control arm. The median PFS was not reached (NR) in the acalabrutinib plus obinutuzumab arm (HR, 0.14; 95% CI, 0.10-0.20; P < .001) and the acalabrutinib monotherapy arm (HR, 0.24; 95% CI, 0.17-0.32; P < .001).

Additionally, overall response rates (ORRs) compared with the control arm were higher for both acalabrutinib plus obinutuzumab and acalabrutinib monotherapy (difference, 6.1%; 95% CI, 0.9%-11.4%; P = .022). Complete response rates were also improved in the acalabrutinib arms (difference, 17.9%; 95% CI, 8.8%-27.0%; P = .022).

The safety profile of acalabrutinib was consistent with previous findings, Dorritie explains, with adverse effects largely limited to manageable cytopenias and infections, she adds. These findings reinforce acalabrutinib’s position as a frontline treatment option for patients with CLL, allowing clinicians to tailor treatment strategies based on individual patient needs.

She explains that although benefits were observed in both of the acalabrutinib-containing arms, the use of the combination was associated with deeper responses in terms of minimal residual disease negativity.