Dr. Bhat on the FDA Approval of Acalabrutinib in CLL

Seema A. Bhat, MD, a hematologist specializing in chronic lymphocytic leukemia (CLL) at The Ohio State University Comprehensive Cancer Center–James, discusses the approval of acalabrutinib (Calquence) in CLL based on data from the phase 3 ELEVATE-TN trial.

The ELEVATE-TN study was an international study conducted in older or younger patients with comorbidities. Patients enrolled in the study were randomized 1:1:1 to 3 arms, says Bhat. The standard arm was comprised of chlorambucil plus obinutuzumab (Gazyva), which was given in a standard fashion for 6 cycles. The 2 experimental arms included acalabrutinib monotherapy and acalabrutinib plus obinutuzumab.

Notably, obinutuzumab was started on cycle 2 and given for a total of 6 cycles, while acalabrutinib was given indefinitely. This trial permitted crossover from the chlorambucil/obinutuzumab arm to the acalabrutinib/obinutuzumab arm upon disease progression. The study met its primary end point of progression-free survival, which led to the FDA’s decision to approve acalabrutinib for patients with CLL or small lymphocytic lymphoma in November 2019, concludes Bhat.