30May

Acalabrutinib versus idelalisib plus rituximab or bendamustine plus rituximab in R/R CLL: ASCEND final results

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


Result:

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%).


Conclusion:

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.


Commentary:

Between the two BTK inhibitors Acalabrutinib bested Ibrutinib with respect to PFS and safety profile, Data on survival benefit still awaited.


Refer to Chronic Lymphocytic Leukemia Market report for detailed Insights.