Seema A. Bhat, MD, discusses the results of the phase 3 ELEVATE-TN trial in patients with treatment-naïve CLL.
Seema A. Bhat, MD, a hematologist specializing in chronic lymphocytic leukemia (CLL) at The Ohio State University Comprehensive Cancer Center–James, discusses the results of the phase 3 ELEVATE-TN trial in patients with treatment-naïve CLL.
Results of the ELEVATE-TN trial showed that after a median follow-up of 28 months, the median progression-free survival (PFS) for the acalabrutinib (Calquence)-containing arms was not reached. In the chlorambucil plus obinutuzumab (Gazyva) arm, however, the median PFS was 22.6 months, says Bhat. The 2-year PFS rates were 93%, 87%, and 47% for acalabrutinib/obinutuzumab, single-agent acalabrutinib, and chemoimmunotherapy, respectively.
The comparison made between the 2 acalabrutinib-containing arms was not a preplanned analysis; however, in a post-hoc analysis, some separation between the curves was seen, Bhat adds. Additionally, the complete response (CR) rates were higher in the acalabrutinib/obinutuzumab arm at 13% compared with 1% patient in single agent acalabrutinib arm. Yet, results from the RESONATE-2 study indicated that CR rates with ibrutinib (Imbruvica), tend to increase over time. Long-term follow-up from the ELEVATE-TN are needed, but nonetheless, these are highly encouraging data, concludes Bhat.