Acalabrutinib + obinutuzumab in TN patients with CLL: 6-year follow-up results from the ELEVATE-TN trial

The randomized phase III ELEVATE-TN trial (NCT02475681) evaluated acalabrutinib ± obinutuzumab vs chlorambucil + obinutuzumab in 535 patients with treatment-naïve (TN) chronic lymphocytic leukemia (CLL). Sharman et al. published 6-year follow-up results from this trial, in Blood.

Key data: At median follow-up of 74.5 months, median progression-free survival (PFS) was not reached for acalabrutinib + obinutuzumab and acalabrutinib monotherapy vs 27.8 months for chlorambucil + obinutuzumab (both p < 0.0001), with estimated 72-month PFS rates of 78.0%, 61.5%, and 17.2%, respectively. The post hoc analysis showed that acalabrutinib + obinutuzumab improved PFS vs acalabrutinib monotherapy (hazard ratio [HR], 0.58; 95% confidence interval [CI], 0.39–0.86; p = 0.0229). Median overall survival (OS) was not reached for all treatments; acalabrutinib + obinutuzumab demonstrated significantly longer OS than chlorambucil + obinutuzumab (HR, 0.62; 95% CI, 0.39–0.97; p = 0.0349).

Key learning: With 6 years of follow-up, the PFS benefit of the acalabrutinib-containing arms was maintained in patients with TN CLL. The OS benefit of first-line acalabrutinib + obinutuzumab vs chlorambucil + obinutuzumab supports its long-term use for the treatment of this patient population.