Acalabrutinib (Calquence), an oral blocker of cancer-cell signaling, was approved by the FDA in 2019 for patients with chronic lymphocytic leukemia (CLL) who relapsed or were refractory to ≥1 previous treatment.
A large clinical trial called ASCEND compared acalabrutinib alone versus older chemoimmunotherapy treatments in patients with relapsed CLL. Patients who were assigned to chemoimmunotherapy in this trial could receive 1 of 2 treatments: idelalisib (Zydelig) plus rituximab (Rituxan; IR) or bendamustine (Bendeka) plus rituximab (BR).1 Researchers presented the final results from the ASCEND study during the ASCO 2020 Virtual Scientific Program.
A total of 310 patients with relapsed or refractory CLL were enrolled in the ASCEND study. Patients received either oral acalabrutinib (100 mg twice daily until disease progression) or a chemoimmunotherapy combination: idelalisib (150 mg twice daily until disease progression) plus rituximab (intravenous [IV] for 8 total infusions), or bendamustine plus rituximab (IV for 6 total 28-day cycles). Researchers tested the effectiveness of each treatment using a variety of measures, including progression-free survival, overall survival, and overall response rate. The safety and tolerability of these treatments were also assessed.
Of the 310 patients enrolled in ASCEND, 155 received acalabrutinib, 119 received IR, and 36 received BR. The median age of patients was 67 years, and 42% of patients had advanced-stage CLL. After following patients for almost 2 years, researchers reported that acalabrutinib extended progression-free time compared with IR and BR. Patients on acalabrutinib had a 73% lower risk of disease progression or death compared with patients on chemoimmunotherapy. After 1.5 years, 82% of patients on acalabrutinib had not experienced disease progression compared with 48% of patients on IR or BR.
Common side effects associated with acalabrutinib treatment included headache, low white blood cell count (neutropenia), diarrhea, upper respiratory infection, low red blood cell count (anemia), and cough. Sixteen percent of patients stopped taking acalabrutinib because of side effects. In contrast, 56% and 17% of patients taking IR and BR, respectively, stopped treatment because of side effects.
The final results from the ASCEND trial affirmed the clinical benefits of acalabrutinib for patients with relapsed or refractory CLL compared with standard-of-care chemoimmunotherapy regimens.
Reference
- Ghia P, Pluta A, Wach M, et al. Acalabrutinib (Acala) versus idelalisib plus rituximab (IdR) or bendamustine plus rituximab (BR) in relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL): ASCEND final results. J Clin Oncol. 2020;38(15_suppl). Abstract 8015.
