Acalabrutinib (Acala) versus idelalisib plus rituximab (IdR) or bendamustine plus ritux-imab (BR) in relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL): ASCEND final results
Abstract Number : 8015
Abstract Type : Poster Discussion Session
Indication : Chronic Lymphocytic Leukemia
Intervention : Acalabrutinib
Company : Acerta Pharma, a member of the AstraZeneca group
Technology : Small molecule
310 pts (acala, n=155; IdR, n=119; BR, n=36) were enrolled (median age: 67 y; del(17p) 16%, del(11q) 27%, Rai stage 3/4 42%). At a median follow-up of 22.0 m, acala significantly prolonged INV-assessed PFS vs IdR/BR (median: not reached vs 16.8 m; hazard ratio: 0.27, P<0.0001); 18-m PFS rates were 82% for acala and 48% for IdR/BR. 18-m OS rate was 88% for both treatment regimens. ORR was 80% with acala vs 84% with IdR/BR (ORR + partial response with lymphocytosis: 92% vs 88%, respectively). Common adverse events (AEs) are listed in the Table. AEs led to drug discontinuation in 16% of acala, 56% of IdR, and 17% of BR pts. AEs of interest included atrial fibrillation (acala 6%, IdR/BR 3%), major hemorrhage (all grade; acala 3%, IdR/BR 3%), grade ≥3 infections (acala 20%, IdR/BR 25%), and second primary malignancies excluding non-melanoma skin cancer (acala 5%, IdR/BR 2%).
Final ASCEND results with additional follow-up confirm earlier findings and support the favorable efficacy and safety of acala compared with standard-of-care regimens in R/R CLL pts.
Between the two BTK inhibitors Acalabrutinib bested Ibrutinib with respect to PFS and safety profile, Data on survival benefit still awaited.