Dr. Pagel on the ELEVATE-TN Trial in CLL

John M. Pagel, MD, PhD, chief of the Hematologic Malignancies Program, and director, Hematopoietic Cell Transplantation Program, at Swedish Cancer Institute in Seattle, discusses the phase III ELEVATE-TN trial in chronic lymphocytic leukemia (CLL).

Results from trial, which were presented at the 2019 ASH Annual Meeting, demonstrated a progression-free survival advantage with acalabrutinib (Calquence) with or without obinutuzumab (Gazyva) versus chlorambucil plus obinutuzumab in patients with treatment-naïve CLL.

At a median follow-up of 28.3 months, acalabrutinib in combination with obinutuzumab led to a 90% reduction in the risk of disease progression or death compared with the combination of chlorambucil and obinutuzumab (HR, 0.10; 95% CI, 0.06-0.17; P <.0001).

Overall survival favored acalabrutinib monotherapy and acalabrutinib/obinutuzumab; however, this advantage was not statistically significant.

These data suggest that the addition of obinutuzumab may not be necessary in all patients. However, if obinutuzumab is given in combination with acalabrutinib, providers should be aware of the potential for increased toxicity, including infusion-related events and neutropenia, says Pagel.

In general, the regimen appears to be well tolerated. The majority of patients remained on treatment after 2 years with low rates of atrial fibrillation, grade 3 hypertension, and major bleeding, concludes Pagel.