Dr Ghia on Long-Term Efficacy With Acalabrutinib Monotherapy in CLL

Paolo Ghia, MD, PhD, professor of medicine, Università Vita-Salute San Raffaele, discusses the long-term follow-up data from a study evaluating the impact of the number of prior lines of therapy on overall survival (OS), progression-free survival (PFS), and time to next treatment (TTNT) in patients with treatment-naive or relapsed/refractory chronic lymphocytic leukemia (CLL) receiving acalabrutinib (Calquence) monotherapy.

The pooled analysis included data from the phase 3 ELEVATE-TN (NCT02475681), ELEVATE-RR (NCT02477696), and ASCEND (NCT02970318) trials. Ghia notes that the primary objective of this evaluation was to describe the impact of the number of prior lines of therapy on OS, PFS, and TTNT in patients with CLL overall and stratified by 17p deletion (del[17p]) status. Secondary objectives included safety and overall response rate.

Findings showed that patients in the overall population who had not received any prior therapy had a 45% lower risk of death vs those who had received 1 prior line of therapy (P = .0185), with 92% and 85% of patients alive at 36 months, respectively. Also, patients in the overall population who had not received any prior therapy had a 56% lower risk of disease progression or death vs those who had received 1 prior line of therapy (P = .0001), with 84% and 73% of patients progression-free at 36 months, respectively.

Regarding patients with del(17p) those who had received 1 prior line of therapy had a 57% lower risk of disease progression or death compared with patients who had received 2 or more prior lines of therapy (P =.0004), with 74% and 45% of patients progression-free at 36 months, respectively. Patients with del(17p) who had received 1 prior line of therapy had a 46% lower risk of initiating subsequent therapy compared with those who had received 2 or more prior lines of therapy (P =.0091), with 72% and 56% of patients not initiating subsequent therapy at 36 months, respectively.

Regarding safety, acalabrutinib exhibited a manageable profile, with common adverse effects being headache, diarrhea, and hypertension, and a low incidence of severe events.