At the 61st American Society of Hematology (ASH) Annual Meeting and Exposition, held December 7-10, in Orlando, Florida, Jeff P. Sharman, MD, from the Willamette Valley Cancer Institute and Research Center, discussed the results of the phase III ELEVATE TN study of acalabrutinib (Calquence) combined with obinutuzumab (Gazyva), compared with acalabrutinib alone or obinutuzumab plus chlorambucil (Leukeran) in patients with treatment-naïve chronic lymphocytic leukemia (CLL).
With regards to the primary endpoint, the median progression-free survival was not observed in either of the acalabrutinib arms, whereas this was observed in the obinutuzumab/chlorambicil arm. A landmark 2-year progression-free survival analysis showed 93% for the combination of BTK and CD20, 87% for BTK alone, and 47% for those patients randomized to the control arm of chlorambicil/obinutuzumab. The hazard ratio was 0.1 with a P value of less than 0.0001 in favor of the experimental combination. And for those patients who received monotherapy, the hazard ratio was 0.2 compared to control also with a highly statistically significant P value. Overall survival was relatively similar at 95% and 92% with a slightly higher incidence of deaths occurring on the control arm compared to the experimental arms, but that did not achieve statistical significance.